baclofen and Disease Models, Animal studies

Disease Models, Animal: Naturally-occurring or experimentally-induced animal diseases with pathological processes analogous to human diseases.

Research Excerpts

Excerpt	Relevance	Reference
"Previous studies from our laboratory showed that anxiety-related responses induced by nicotine (NIC), measured by the elevated plus maze, were abolished by 2-OH-saclofen (GABAB receptor antagonist) (1 mg/kg; ip) or the lack of GABAB receptors (GABAB1 knockout mice)."	7.80	Involvement of GABAB receptors in biochemical alterations induced by anxiety-related responses to nicotine in mice: genetic and pharmacological approaches. ( Balerio, GN; Bettler, B; Pedrón, VT; Varani, AP, 2014)
" Our aims were to investigate the effect and mechanism of action of the GABA(B) receptor agonist, baclofen, on gastric hypersensitivity in a validated rat model of functional dyspepsia (FD)."	7.77	The analgesic effects of the GABAB receptor agonist, baclofen, in a rodent model of functional dyspepsia. ( Liu, LS; Pasricha, PJ; Shenoy, M, 2011)
"Baclofen, a specific GABA(B) receptor agonist, is used to treat spasticity and its off-label use includes the treatment of pain."	7.75	Role of GABA(B) receptor agonist baclofen in acute pain modulation during the early postnatal period. ( Franek, M; Vaculin, S, 2009)
"We investigated the effects of baclofen, a selective GABA-B receptor agonist, on certain behaviours in rats after short-term hypoxia, as a model of experimentally induced amnesia."	7.71	Baclofen prevents hypoxia-induced consolidation impairment for passive avoidance in rats. ( Car, H; Nadlewska, A; Oksztel, R; Wiśniewski, K, 2001)
"Melatonin is an effective treatment in MS patients and experimental autoimmune encephalomyelitis (EAE), a mouse model of MS."	5.48	Spasticity Treatment Ameliorates the Efficacy of Melatonin Therapy in Experimental Autoimmune Encephalomyelitis (EAE) Mouse Model of Multiple Sclerosis. ( Farhadi, N; Ghareghani, M; Sadeghi, H; Zibara, K, 2018)
"R-baclofen treatment reversed social approach deficits in BTBR T+ Itpr3tf/J (BTBR), reduced repetitive self-grooming and high marble burying scores in BTBR, and reduced stereotyped jumping in C58/J (C58), at nonsedating doses."	5.42	GABAB Receptor Agonist R-Baclofen Reverses Social Deficits and Reduces Repetitive Behavior in Two Mouse Models of Autism. ( Baker, S; Butler-Struben, HM; Crawley, JN; Hayes, JE; Pride, MC; Puhger, KR; Silverman, JL, 2015)
"Cough was elicited by mechanical stimulation of the lumen of the intrathoracic trachea in spontaneously breathing cats."	5.39	Influence of baclofen on laryngeal and spinal motor drive during cough in the anesthetized cat. ( Castillo, D; Pitts, T, 2013)
"tended to decrease seizure intensity and at a dose of 10 mg/kg was ineffective at all."	5.29	Further evidence for the interactions between angiotensin II and GABAergic transmission in pentylenetetrazol kindling seizures in mice. ( Georgiev, VP; Kambourova, TS; Lazarova, MB, 1995)
"(-)-Baclofen was the only one of the three compounds tested that reversed in a dose-dependent manner the effects of tone exposure on both the amplitude of the click-evoked potentials recorded from the IC and on measures of the changes in temporal integration based on these potentials."	5.29	Effects of (-)-baclofen, clonazepam, and diazepam on tone exposure-induced hyperexcitability of the inferior colliculus in the rat: possible therapeutic implications for pharmacological management of tinnitus and hyperacusis. ( Møller, AR; Szczepaniak, WS, 1996)
"Previous studies from our laboratory showed that anxiety-related responses induced by nicotine (NIC), measured by the elevated plus maze, were abolished by 2-OH-saclofen (GABAB receptor antagonist) (1 mg/kg; ip) or the lack of GABAB receptors (GABAB1 knockout mice)."	3.80	Involvement of GABAB receptors in biochemical alterations induced by anxiety-related responses to nicotine in mice: genetic and pharmacological approaches. ( Balerio, GN; Bettler, B; Pedrón, VT; Varani, AP, 2014)
" Our aims were to investigate the effect and mechanism of action of the GABA(B) receptor agonist, baclofen, on gastric hypersensitivity in a validated rat model of functional dyspepsia (FD)."	3.77	The analgesic effects of the GABAB receptor agonist, baclofen, in a rodent model of functional dyspepsia. ( Liu, LS; Pasricha, PJ; Shenoy, M, 2011)
"Past work has demonstrated that kainic acid (KA)-induced seizures could cause the enhancement of excitation and lead to neuronal death in rat hippocampus."	3.76	Coactivation of GABA receptors inhibits the JNK3 apoptotic pathway via disassembly of GluR6-PSD-95-MLK3 signaling module in KA-induced seizure. ( Han, D; Li, C; Pei, DS; Wang, WW; Xu, B; Yu, HM; Yu, XJ; Zhang, GY; Zhu, J, 2010)
"Baclofen, a specific GABA(B) receptor agonist, is used to treat spasticity and its off-label use includes the treatment of pain."	3.75	Role of GABA(B) receptor agonist baclofen in acute pain modulation during the early postnatal period. ( Franek, M; Vaculin, S, 2009)
" This study compared the neuroprotective efficacies of muscimol, a GABA A receptor agonist, and a GABA B receptor agonist baclofen in rat brain ischemia."	3.74	Additive neuroprotection of GABA A and GABA B receptor agonists in cerebral ischemic injury via PI-3K/Akt pathway inhibiting the ASK1-JNK cascade. ( Li, C; Xu, J; Yin, XH; Zhang, GY, 2008)
"This study investigated the effect of GABAA (muscimol, MUSC) and GABAB (baclofen, BACL) agonist receptors microinjected into medial accumbens shell on feeding and the level of fear in free-feeding rats submitted to the elevated plus-maze (EPM), an animal model of anxiety."	3.74	GABAA and GABAB agonist microinjections into medial accumbens shell increase feeding and induce anxiolysis in an animal model of anxiety. ( da Cunha, IC; de Lima, TC; Faria, MS; Ferraz, A; Lopes, AP; Neto, JM; Paschoalini, MA; Steffens, SM; Vargas, JC, 2007)
" We previously reported that baclofen, the prototypical GABA(B) agonist, elicits antipsychotic-like effects in the rat paradigm of prepulse inhibition (PPI) of the startle, a highly validated animal model of schizophrenia."	3.74	Activation of GABA(B) receptors reverses spontaneous gating deficits in juvenile DBA/2J mice. ( Bortolato, M; Castelli, MP; Fà, M; Frau, R; Gessa, GL; Marrosu, F; Mereu, G; Orrù, M; Piras, AP; Puligheddu, M; Tuveri, A, 2007)
"We investigated the effects of baclofen, a selective GABA-B receptor agonist, on certain behaviours in rats after short-term hypoxia, as a model of experimentally induced amnesia."	3.71	Baclofen prevents hypoxia-induced consolidation impairment for passive avoidance in rats. ( Car, H; Nadlewska, A; Oksztel, R; Wiśniewski, K, 2001)
"In order to determine whether changes in synaptic inhibition are involved in chronic models of epilepsy, it is necessary to understand the factors which determine the kinetics of fast gamma-aminobutyric acid (GABA)ergic inhibition."	3.69	Analysis of the kinetics of synaptic inhibition points to a reduction in GABA release in area CA1 of the genetically epileptic mouse, El. ( Andreasen, M; Fueta, Y; Lambert, JD; Roepstorff, A, 1996)
"Experimental studies indicate that the effects of spinal cord stimulation (SCS) on 'hypersymptoms' in neuropathic pain conditions may at least partly be mediated via GABAergic and adenosine-dependent mechanisms."	3.69	Modulation of spinal pain mechanisms by spinal cord stimulation and the potential role of adjuvant pharmacotherapy. ( Cui, JG; Linderoth, B; Meyerson, BA; O'Connor, WT; Segerdahl, M; Sollevi, A; Stiller, CO; Yakhnitsa, V, 1997)
"It may also decrease alcohol withdrawal symptoms."	2.48	Is baclofen a revolutionary medication in alcohol addiction management? Review and recent updates. ( Aubin, HJ; Benyamina, A; Blecha, L; Gorsane, MA; Hache, G; Kebir, O; Reynaud, M, 2012)
"A mouse model of spasticity was developed by producing incomplete SCI at the 9th thoracic level."	1.56	The beneficial aspects of spasticity in relation to ambulatory ability in mice with spinal cord injury. ( Konno, DJ; Kubota, K; Maeda, T; Matsumoto, Y; Nakashima, Y; Okada, S; Saito, T; Tanaka, M; Yokota, K; Yoshizaki, S, 2020)
"In baclofen treatment group, thermal hyperalgesia and formalin test improved in comparison with morphine tolerance group."	1.56	Repeated Administration of Baclofen Modulates TRPV-1 Channel Expression by PKC Pathway in Dorsal Root Ganglia of Spinal Cord in a Morphine Tolerance Model of Rats ( Ashabi, G; Hoseini, M; Karimiyan, SM; Mehrabadi, S; Moradbeygi, K, 2020)
" A novel polytherapeutic proof-of-principle approach using PXT3003, a low-dose combination of baclofen, naltrexone and sorbitol, slowed disease progression after long-term dosing in adult Pmp22 transgenic rats, a known animal model of CMT1A."	1.51	Early short-term PXT3003 combinational therapy delays disease onset in a transgenic rat model of Charcot-Marie-Tooth disease 1A (CMT1A). ( Adam, J; Cohen, D; Ewers, D; Hajj, R; Kungl, T; Mroczek, M; Nabirotchkin, S; Nave, KA; Prukop, T; Sereda, MW; Stenzel, J; Wernick, S, 2019)
"Specifically, postsurgical pain continues to be a frequent and undermanaged condition."	1.51	Antiallodynic effects of the selective NaV1.7 inhibitor Pn3a in a mouse model of acute postsurgical pain: evidence for analgesic synergy with opioids and baclofen. ( Alewood, PF; Cheneval, O; Dekan, Z; Deuis, JR; Morgan, M; Mueller, A; Schroeder, CI; Starobova, H; Vetter, I, 2019)
"Melatonin is an effective treatment in MS patients and experimental autoimmune encephalomyelitis (EAE), a mouse model of MS."	1.48	Spasticity Treatment Ameliorates the Efficacy of Melatonin Therapy in Experimental Autoimmune Encephalomyelitis (EAE) Mouse Model of Multiple Sclerosis. ( Farhadi, N; Ghareghani, M; Sadeghi, H; Zibara, K, 2018)
"Binge drinking is defined as a pattern of drinking leading to intoxication in a single short session and is a serious but preventable public health problem."	1.48	Evaluation of alcohol use disorders pharmacotherapies in a new preclinical model of binge drinking. ( Diouf, M; González-Marín, MC; Jeanblanc, J; Lebourgeois, S; Naassila, M, 2018)
"Binge drinking is a form of abusive alcohol drinking defined by the NIAAA as a drinking to blood alcohol levels (BALs)>0."	1.46	High Drinking in the Dark (HDID) mice are sensitive to the effects of some clinically relevant drugs to reduce binge-like drinking. ( Barkley-Levenson, A; Crabbe, JC; Hack, WR; Huang, LC; Metten, P; Ozburn, AR; Schlumbohm, JP; Spence, SE, 2017)
"Spinocerebellar ataxia type 1 (SCA1) is a progressive neurodegenerative disease caused by a gene defect, leading to movement disorder such as cerebellar ataxia."	1.46	Progressive impairment of cerebellar mGluR signalling and its therapeutic potential for cerebellar ataxia in spinocerebellar ataxia type 1 model mice. ( Hirai, H; Hosoi, N; Sato, Y; Shuvaev, AN; Yanagihara, D, 2017)
"Baclofen treatment significantly improved the spatial working memory impairments caused by 2VO, accompanied with a reversion of 2VO-induced down-regulation of HCN2."	1.43	Baclofen ameliorates spatial working memory impairments induced by chronic cerebral hypoperfusion via up-regulation of HCN2 expression in the PFC in rats. ( Chen, C; Fu, T; Guo, L; He, Z; Li, C; Lu, Q; Lu, Y; Luo, P; Xu, X, 2016)
"R-baclofen treatment reversed social approach deficits in BTBR T+ Itpr3tf/J (BTBR), reduced repetitive self-grooming and high marble burying scores in BTBR, and reduced stereotyped jumping in C58/J (C58), at nonsedating doses."	1.42	GABAB Receptor Agonist R-Baclofen Reverses Social Deficits and Reduces Repetitive Behavior in Two Mouse Models of Autism. ( Baker, S; Butler-Struben, HM; Crawley, JN; Hayes, JE; Pride, MC; Puhger, KR; Silverman, JL, 2015)
" Whereas overall binge-like saccharin intake was significantly reduced by R(+)-baclofen, chronic intake was not significantly altered."	1.42	Bidirectional enantioselective effects of the GABAB receptor agonist baclofen in two mouse models of excessive ethanol consumption. ( Blasingame, SN; Boehm, SL; Kasten, CR, 2015)
" Chronic administration of GABAB receptors agonist baclofen significantly alleviated neuronal damage."	1.42	Baclofen mediates neuroprotection on hippocampal CA1 pyramidal cells through the regulation of autophagy under chronic cerebral hypoperfusion. ( Guo, LJ; Li, CJ; Liu, L; Lu, Y; Luo, C; Sun, J; Zong, XG, 2015)
"Baclofen treatment resulted in recovery of the weakened RDD at 1 week post stroke."	1.40	Weakened rate-dependent depression of Hoffmann's reflex and increased motoneuron hyperactivity after motor cortical infarction in mice. ( Kiyama, H; Lee, S; Toda, T; Yamashita, T, 2014)
"In addition to spasticity, TBI patients exhibit enduring cognitive, balance, and other motor impairments."	1.39	Effects of acute intrathecal baclofen in an animal model of TBI-induced spasticity, cognitive, and balance disabilities. ( Bose, P; Hou, J; Keener, J; Nelson, R; Nissim, N; Parmer, R; Thompson, FJ; Wacnik, PW, 2013)
"Cough was elicited by mechanical stimulation of the lumen of the intrathoracic trachea in spontaneously breathing cats."	1.39	Influence of baclofen on laryngeal and spinal motor drive during cough in the anesthetized cat. ( Castillo, D; Pitts, T, 2013)
"Orofacial pain was induced by subcutaneous injection of formalin (50 μl, 5 %) in the upper lip region, and the number of jumps and time spent face rubbing was recorded for 40 min."	1.39	Antinociceptive effects of H₃ (R-methylhistamine) and GABA(B) (baclofen)-receptor ligands in an orofacial model of pain in rats. ( Kostrzewa, RM; Kowalińska-Kania, M; Malinowska-Borowska, J; Nowak, D; Nowak, P, 2013)
"Seizure was confirmed using electroencephalography (EEG) data obtained from the Laxtha EEG-monitoring device in the EEG recording room and EEG was monitored 5-15 min after PTZ injection."	1.39	Decreased GABABR expression and increased neuronal cell death in developing rat brain after PTZ-induced seizure. ( Al-Qahtani, MH; Ansari, SA; Bibi, F; Karim, S; Kim, MO; Naseer, MI; Ullah, I; Ullah, N, 2013)
" Finally, the chronic administration of STX209 in juvenile mice corrected the increased spine density in Fmr1-knockout mice without affecting spine density in wild-type mice."	1.38	Reversal of disease-related pathologies in the fragile X mouse model by selective activation of GABAB receptors with arbaclofen. ( Bear, MF; Brynczka, C; Carpenter, RL; Hammond, RS; Healy, AM; Henderson, C; Kind, PC; Kinoshita, MN; Paylor, R; Postma, FR; Rush, R; Shumway, M; Thomas, A; Vanderklish, PW; Warren, ST; Wijetunge, L, 2012)
"It suppressed tonic phase of generalized seizures induced by pentetrazol in 7-, 12- and 18-day-old rats and increased their latency in 7- and 12-day-old animals."	1.35	Anticonvulsant action of GABA-B receptor agonist SKF97541 differs from that of baclofen. ( Mares, P, 2008)
"At 4 weeks after Th9-10 spinal cord transection awake cystometry and recordings of external urethral sphincter electromyogram were performed to examine the effect of intrathecal application of the gamma-aminobutyric acid A and B agonists muscimol and baclofen or the gamma-aminobutyric acid A and B antagonists bicuculline and saclofen (Tocris Cookson, Ellisville, Missouri), respectively, at the level of the L6-S1 spinal cord."	1.35	GABA receptor activation in the lumbosacral spinal cord decreases detrusor overactivity in spinal cord injured rats. ( Chancellor, MB; de Groat, WC; Hiragata, S; Miyazato, M; Sasatomi, K; Sugaya, K; Yoshimura, N, 2008)
"Baclofen or saline was microinjected into the anterior or posterior VTA of male C57BL/6J mice."	1.35	Site-specific microinjection of baclofen into the anterior ventral tegmental area reduces binge-like ethanol intake in male C57BL/6J mice. ( Boehm, SL; Moore, EM, 2009)
"Infantile spasms is a catastrophic childhood seizure disorder for which few animal models exist."	1.35	Infantile spasms and Down syndrome: a new animal model. ( Aleem, IS; Ashraf, A; Cortez, MA; Kanawaty, A; Liu, CC; Sadeghnia, HR; Shen, L; Snead, OC; Stewart, L; Trepanier, CH; Wu, Y, 2009)
"Mechanical allodynia was maximal by 1 week and persisted at blunted levels for at least 18 weeks after injury."	1.33	Spinal nerve ligation does not alter the expression or function of GABA(B) receptors in spinal cord and dorsal root ganglia of the rat. ( Bettler, B; Engle, MP; Gassman, M; Hammond, DL; Sykes, KT, 2006)
"Baclofen, which is a specific agonist of the metabotropic GABA(B) receptor, is used in clinical practice for the treatment of spasticity of skeletal muscles."	1.32	GABA(B) receptor agonist baclofen has non-specific antinociceptive effect in the model of peripheral neuropathy in the rat. ( Franek, M; Rokyta, R; Vaculín, S, 2004)
"Diabetic animals displayed marked mechanical hyperalgesia, and some thermal hypoalgesia."	1.30	Critical evaluation of the streptozotocin model of painful diabetic neuropathy in the rat. ( Eastwood, C; Fox, A; Gentry, C; Manning, D; Urban, L, 1999)
"tended to decrease seizure intensity and at a dose of 10 mg/kg was ineffective at all."	1.29	Further evidence for the interactions between angiotensin II and GABAergic transmission in pentylenetetrazol kindling seizures in mice. ( Georgiev, VP; Kambourova, TS; Lazarova, MB, 1995)
"Morphine pre-treatment was less effective in preventing development of hyperalgesia; however, whilst the ipsilateral (146 +/- 18 g) paw withdrawal threshold tended to be lower than the contralateral (183 +/- 8 g), this was not significant."	1.29	Pre-emptive administration of clonidine prevents development of hyperalgesia to mechanical stimuli in a model of mononeuropathy in the rat. ( Birch, PJ; Elliott, PJ; Harrison, SM; Smith, GD; Wiseman, J, 1993)
"(-)-Baclofen was the only one of the three compounds tested that reversed in a dose-dependent manner the effects of tone exposure on both the amplitude of the click-evoked potentials recorded from the IC and on measures of the changes in temporal integration based on these potentials."	1.29	Effects of (-)-baclofen, clonazepam, and diazepam on tone exposure-induced hyperexcitability of the inferior colliculus in the rat: possible therapeutic implications for pharmacological management of tinnitus and hyperacusis. ( Møller, AR; Szczepaniak, WS, 1996)
"Quinolinic acid (QA) is an endogenous excitotoxin present in mammalian brain that reproduces many of the histologic and neurochemical features of Huntington's disease (HD)."	1.27	Systemic approaches to modifying quinolinic acid striatal lesions in rats. ( Beal, MF; Ferrante, RJ; Kowall, NW; Martin, JB; Swartz, KJ, 1988)

Research

Studies (155)

Authors

Clinical Trials (6)

Trial Overview

Trial Outcomes

Change From Pre-dose in the Repeatable Battery for the Assessment of Neuropsychological Status at 4 Hours Post Dose

Timeframe	Studies, this research(%)	All Research%
pre-1990	6 (3.87)	18.7374
1990's	15 (9.68)	18.2507
2000's	48 (30.97)	29.6817
2010's	74 (47.74)	24.3611
2020's	12 (7.74)	2.80

Authors	Studies
Solinski, HJ	1
Dranchak, P	1
Oliphant, E	1
Gu, X	1
Earnest, TW	1
Braisted, J	1
Inglese, J	1
Hoon, MA	1
Abrams, RPM	1
Yasgar, A	1
Teramoto, T	1
Lee, MH	1
Dorjsuren, D	1
Eastman, RT	1
Malik, N	1
Zakharov, AV	1
Li, W	1
Bachani, M	1
Brimacombe, K	1
Steiner, JP	1
Hall, MD	1
Balasubramanian, A	1
Jadhav, A	1
Padmanabhan, R	1
Simeonov, A	1
Nath, A	1
Sun, R	1
Tsunekawa, T	1
Hirose, T	1
Yaginuma, H	1
Taki, K	1
Mizoguchi, A	1
Miyata, T	1
Kobayashi, T	1
Sugiyama, M	1
Onoue, T	1
Takagi, H	1
Hagiwara, D	1
Ito, Y	1
Iwama, S	1
Suga, H	1
Banno, R	1
Bettler, B	3
Arima, H	1
Janz, P	1
Nicolas, MJ	1
Redondo, RL	1
Valencia, M	1
Jonak, CR	1
Pedapati, EV	1
Schmitt, LM	1
Assad, SA	1
Sandhu, MS	1
DeStefano, L	1
Ethridge, L	1
Razak, KA	1
Sweeney, JA	1
Binder, DK	1
Erickson, CA	1
Park, JY	1
Park, J	1
Baek, J	1
Chang, JW	1
Kim, YG	1
Chang, WS	1
Zhang, Y	1
Yang, J	1
Sevilla, A	1
Weller, R	1
Wu, J	1
Su, C	1
Zheng, C	1
Rodriguez-Blanco, YF	1
Gitlin, M	1
Candiotti, KA	1
Yoshizaki, S	1
Yokota, K	1
Kubota, K	1
Saito, T	1
Tanaka, M	1
Konno, DJ	1
Maeda, T	1
Matsumoto, Y	1
Nakashima, Y	1
Okada, S	1
Gawlińska, K	1
Jastrzębska, J	1
Gamberini, S	1
Gawliński, D	1
Pieniążek, R	1
Suder, A	1
Wydra, K	1
Frankowska, M	2
Mehrabadi, S	1
Karimiyan, SM	1
Ashabi, G	1
Moradbeygi, K	1
Hoseini, M	1
Bushart, DD	1
Huang, H	2
Man, LJ	1
Morrison, LM	1
Shakkottai, VG	1
Zou, HW	1
Li, ZL	1
Jing, XY	1
Wang, Y	2
Liu, YJ	1
Li, LF	1
Khakpoor, M	1
Vaseghi, S	1
Mohammadi-Mahdiabadi-Hasani, MH	1
Nasehi, M	3
Zhou, YQ	1
Chen, SP	1
Liu, DQ	1
Manyande, A	1
Zhang, W	4
Yang, SB	1
Xiong, BR	1
Fu, QC	1
Song, ZP	1
Rittner, H	1
Ye, DW	1
Tian, YK	1
Zhang, H	1
Qian, YL	1
Li, C	6
Liu, D	1
Wang, L	2
Wang, XY	1
Liu, MJ	1
Liu, H	1
Zhang, S	1
Guo, XY	1
Yang, JX	1
Ding, HL	1
Koo, JW	1
Mouzon, E	1
Deisseroth, K	1
Nestler, EJ	1
Zachariou, V	1
Han, MH	1
Cao, JL	1
Holtyn, AF	1
Kaminski, BJ	2
Weerts, EM	2
Zarrabian, S	1
Farrahizadeh, M	1
Zarrindast, MR	2
Crabbe, JC	1
Ozburn, AR	1
Metten, P	1
Barkley-Levenson, A	1
Schlumbohm, JP	1
Spence, SE	1
Hack, WR	1
Huang, LC	1
Stoppel, LJ	1
Kazdoba, TM	1
Schaffler, MD	1
Preza, AR	1
Heynen, A	1
Crawley, JN	2
Bear, MF	2
Pilipenko, V	1
Narbute, K	1
Beitnere, U	1
Rumaks, J	1
Pupure, J	1
Jansone, B	1
Klusa, V	1
Cai, XJ	1
Hu, CM	1
Martinello, K	1
Sciaccaluga, M	1
Morace, R	1
Mascia, A	1
Arcella, A	1
Esposito, V	1
Fucile, S	1
Ghareghani, M	1
Zibara, K	1
Sadeghi, H	1
Farhadi, N	1
Vengeliene, V	1
Takahashi, TT	1
Dravolina, OA	1
Belozertseva, I	1
Zvartau, E	1
Bespalov, AY	1
Spanagel, R	1
Zeidler, S	1
Pop, AS	1
Jaafar, IA	1
de Boer, H	1
Buijsen, RAM	1
de Esch, CEF	1
Nieuwenhuizen-Bakker, I	1
Hukema, RK	1
Willemsen, R	1
González-Marín, MC	1
Lebourgeois, S	1
Jeanblanc, J	1
Diouf, M	1
Naassila, M	1
Migita, K	1
Matsuzaki, Y	1
Koga, K	1
Matsumoto, T	1
Mishima, K	1
Hara, S	1
Honda, K	1
Prukop, T	1
Stenzel, J	1
Wernick, S	1
Kungl, T	1
Mroczek, M	1
Adam, J	1
Ewers, D	1
Nabirotchkin, S	4
Nave, KA	2
Hajj, R	4
Cohen, D	4
Sereda, MW	2
Mueller, A	1
Starobova, H	1
Morgan, M	1
Dekan, Z	1
Cheneval, O	1
Schroeder, CI	1
Alewood, PF	1
Deuis, JR	1
Vetter, I	1
Nowak, P	1
Kowalińska-Kania, M	1
Nowak, D	1
Kostrzewa, RM	1
Malinowska-Borowska, J	1
Varani, AP	3
Antonelli, MC	2
Balerio, GN	4
Castillo, D	1
Pitts, T	1
Dugladze, T	1
Maziashvili, N	1
Börgers, C	1
Gurgenidze, S	1
Häussler, U	1
Winkelmann, A	1
Haas, CA	1
Meier, JC	1
Vida, I	1
Kopell, NJ	1
Gloveli, T	1
Sweeney, FF	1
O'Leary, OF	1
Cryan, JF	2
Kim, W	1
Seo, H	1
Lee, S	1
Toda, T	1
Kiyama, H	1
Yamashita, T	1
Pedrón, VT	1
Billingslea, EN	1
Tatard-Leitman, VM	1
Anguiano, J	1
Jutzeler, CR	1
Suh, J	1
Saunders, JA	1
Morita, S	1
Featherstone, RE	1
Ortinski, PI	2
Gandal, MJ	2
Lin, R	1
Liang, Y	2
Gur, RE	2
Carlson, GC	1
Hahn, CG	1
Siegel, SJ	2
Bai, HP	1
Liu, P	1
Wu, YM	1
Guo, WY	1
Guo, YX	1
Wang, XL	2
Bolton, MM	1
Heaney, CF	1
Murtishaw, AS	1
Sabbagh, JJ	1
Magcalas, CM	1
Kinney, JW	1
Limpens, JH	1
Damsteegt, R	1
Broekhoven, MH	1
Voorn, P	1
Vanderschuren, LJ	1
Li, X	1
Zeric, T	1
Kambhampati, S	1
Bossert, JM	1
Shaham, Y	1
Chumakov, I	3
Milet, A	3
Cholet, N	3
Primas, G	1
Boucard, A	2
Pereira, Y	2
Graudens, E	2
Mandel, J	1
Laffaire, J	2
Foucquier, J	3
Glibert, F	1
Bertrand, V	2
Vial, E	2
Guedj, M	3
Tyagi, RK	1
Bisht, R	1
Pant, J	1
Kumar, P	1
Majeed, AB	1
Prakash, A	1
Kasten, CR	1
Blasingame, SN	1
Boehm, SL	2
Toulorge, D	2
Traoré, S	1
Callizot, N	1
Steinschneider, R	1
Maurice, T	1
Scart-Grès, C	1
Silverman, JL	1
Pride, MC	1
Hayes, JE	1
Puhger, KR	1
Butler-Struben, HM	1
Baker, S	1
Qin, M	1
Huang, T	1
Kader, M	1
Krych, L	1
Xia, Z	1
Burlin, T	1
Zeidler, Z	1
Zhao, T	1
Smith, CB	1
Martins, I	1
Carvalho, P	1
de Vries, MG	1
Teixeira-Pinto, A	1
Wilson, SP	1
Westerink, BHC	1
Tavares, I	1
Xu, C	1
Tu, H	1
Sun, Q	1
Hu, P	1
Hu, Y	1
Rondard, P	1
Liu, J	2
Khanegheini, A	1
Liu, L	1
Li, CJ	1
Lu, Y	2
Zong, XG	1
Luo, C	1
Sun, J	1
Guo, LJ	1
Huang, D	1
Xu, J	2
Tong, J	1
Wang, Z	1
Huang, L	1
Yang, Y	1
Bai, X	1
Wang, P	1
Suo, H	1
Ma, Y	1
Yu, M	1
Fei, J	1
Huang, F	1
Robelet, S	1
Mitry, R	1
Vickers, SP	1
Hackett, D	1
Murray, F	1
Hutson, PH	1
Heal, DJ	1
Castro, J	1
Harrington, AM	1
Garcia-Caraballo, S	1
Maddern, J	1
Grundy, L	1
Zhang, J	1
Page, G	1
Miller, PE	1
Craik, DJ	1
Adams, DJ	1
Brierley, SM	1
Yan, Y	1
Cheng, J	1
Xiao, G	1
Gu, J	1
Zhang, L	1
Yuan, S	1
Wang, J	2
Shen, Y	1
Zhou, YD	1
Luo, P	1
Chen, C	1
Fu, T	1
Lu, Q	1
Xu, X	1
He, Z	1
Guo, L	1
Li, G	1
Lv, J	1
Wan, P	1
Li, Y	1
Jiang, H	1
Jin, Q	1
Shuvaev, AN	1
Hosoi, N	1
Sato, Y	1
Yanagihara, D	1
Hirai, H	1
Cevikbas, F	1
Braz, JM	1
Wang, X	1
Solorzano, C	1
Sulk, M	1
Buhl, T	1
Steinhoff, M	1
Basbaum, AI	1
Li, DP	1
Yang, Q	1
Pan, HM	1
Pan, HL	2
Maccioni, P	2
Fantini, N	1
Froestl, W	2
Carai, MA	4
Gessa, GL	5
Colombo, G	4
Brusberg, M	1
Ravnefjord, A	1
Martinsson, R	1
Larsson, H	1
Martinez, V	1
Lindström, E	1
Hadengue, A	1
Gache, P	1
Fejgin, K	1
Pålsson, E	1
Wass, C	1
Finnerty, N	1
Lowry, J	1
Klamer, D	1
Inaba, Y	1
D'Antuono, M	1
Bertazzoni, G	1
Biagini, G	1
Avoli, M	1
Cortez, MA	1
Shen, L	1
Wu, Y	1
Aleem, IS	1
Trepanier, CH	1
Sadeghnia, HR	1
Ashraf, A	1
Kanawaty, A	1
Liu, CC	1
Stewart, L	1
Snead, OC	2
Fattore, L	1
Spano, MS	1
Cossu, G	1
Scherma, M	1
Fratta, W	1
Fadda, P	1
Miranda, F	1
Jiménez, JC	1
Cedillo, LN	1
Sandoval-Sánchez, A	1
Millán-Mejía, P	1
Sánchez-Castillo, H	1
Velázquez-Martínez, DN	1
Moore, EM	1
Franek, M	2
Vaculin, S	2
Xu, B	1
Wang, WW	1
Yu, XJ	1
Zhu, J	1
Yu, HM	2
Han, D	2
Pei, DS	1
Zhang, GY	3
Zhang, Q	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Neurophysiological and Acute Pharmacological Studies in FXS Patients[NCT02998151]	Early Phase 1	29 participants (Actual)	Interventional	2016-01-31	Completed
International, Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Study Assessing in Parallel Groups the Efficacy and Safety of 2 Doses of PXT3003 in Patients With Charcot-Marie-Tooth Disease Type 1A Treated 15 Months[NCT02579759]	Phase 3	323 participants (Actual)	Interventional	2015-12-31	Completed
Benefit of Acupuncture Combined to Regional Analgesia for Post Operative Pain Relief After Hysterectomy[NCT06002464]		72 participants (Anticipated)	Interventional	2023-09-01	Recruiting
Effects of Corticotropin-Releasing Hormone Receptor 1 (CRH1) Antagonism on Stress-Induced Craving in Alcoholic Women With High Anxiety: an Experimental Medicine Study[NCT01187511]	Phase 2	44 participants (Actual)	Interventional	2010-01-31	Completed
Corticotropin-Releasing Hormone Receptor 1 (CRH1) Antagonism in Anxious Alcoholics[NCT01227980]	Phase 2	70 participants (Actual)	Interventional	2010-10-31	Completed
Modulation of Pharmacologically Induced Alcohol Craving in Recently Detoxified Alcoholics[NCT00605904]	Phase 2	37 participants (Actual)	Interventional	2008-01-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Four 10-item lists of unrelated words were presented orally to the examinee who was then required to immediately recall words presented, at both pre-dose and post-dose timepoints. The impact of drug was assessed by subtracting the number of words remembered post-dose from the number of words remembered pre-dose. Lower numbers indicate more words remembered post-dose; higher numbers indicate more words remembered pre-dose. (NCT02998151)
Timeframe: Pre-dose, 4-hour post dose

Change in EEG Relative Gamma Power

Intervention	number of words remembered (Mean)
Placebo	-.20
Acamprosate	-1.47
Lovastatin	-1.25
Minocycline	-.69
Baclofen	-.88

EEG relative gamma power at rest was calculated as the percent of power in the gamma frequencies relative to the sum of power in all frequency bands, averaged across electrodes, and calculated separately at pre-dose and post-dose timepoints. To assess the impact of drug, the pre-dose relative gamma power was subtracted from post-dose relative gamma power. Higher numbers indicate more relative gamma power post-dose; lower numbers indicate more relative gamma power pre-dose. (NCT02998151)
Timeframe: Pre-dose, 4-hour post-dose

Clinical Global Impressions-Improvement

Intervention	percent of power in gamma frequencies (Mean)
Placebo	0.0024
Acamprosate	-0.0077
Lovastatin	-0.0039
Minocycline	0.0019
Baclofen	-0.0160

The Clinical Global Impressions - Improvement (CGI-I) requires the clinician to assess how much the patient's illness has changed relative to pre-dose, from 1 (very much improved) to 7 (very much worse). (NCT02998151)
Timeframe: 4-hour post-dose

Test of Attentional Performance for Children (KiTAP) Test of Alertness

Intervention	score on a scale (Mean)
Placebo	3.70
Acamprosate	3.88
Lovastatin	3.97
Minocycline	3.81
Baclofen	3.94

Computerized task where an examinee is required to push a key when a target stimulus is presented on the screen. Scores are presented as change in median reaction time (RT), in milliseconds. (NCT02998151)
Timeframe: Predose, 4-hour post-dose

Woodcock Johnson Test of Cognitive Abilities - Auditory Attention Task

Intervention	change in median RT in milliseconds (Mean)
Placebo	13.76
Acamprosate	-28.64
Lovastatin	18.59
Minocycline	26.85
Baclofen	-31.44

Woodcock Johnson Test of Cognitive Abilities III Auditory Attention subscale. Participants must identify orally presented words amid increasingly intense background noise. The scores for this subtask range from 0-50, with higher scores indicating a better outcome. Raw scores for this subscale are reported (rather than standard scores, or age- or grade-equivalents). (NCT02998151)
Timeframe: 4-hour post-dose

Number of Participants With ONLS Therapy Response 1

Intervention	score on a scale (Mean)
Placebo	32.84
Acamprosate	33.07
Lovastatin	32.93
Minocycline	33.24
Baclofen	33

ONLS Therapy Response 1 was defined as the number of participants (responders) with an improvement on final ONLS Total Score of at least one point. A higher response rate indicate a better clinical condition. (NCT02579759)
Timeframe: From Baseline to Month 15

Number of Participants With ONLS Therapy Response 2

Intervention	Number of Participants (Number)
PXT3003 Dose 1	16
PXT3003 Dose 2	14
Placebo	14

"ONLS Therapy Response 2 was defined as the number of participants with no deterioration (responders) on final ONLS Total Score.~A higher response rate indicates a better clinical condition." (NCT02579759)
Timeframe: From Baseline to Month 15

Incidence of AE Leading to Withdrawal of Study Drug

Intervention	Number of Participants (Number)
PXT3003 Dose 1	66
PXT3003 Dose 2	42
Placebo	58

Safety and tolerability of PXT3003 were compared to placebo on the incidence of TEAEs leading to withdrawal of study drug. (NCT02579759)
Timeframe: The period between the patient signing the informed consent and 30 days after the end of study (i.e. completion/early discontinuation/last contact as recorded on the 'Study Completion on Early Termination' form up to 15 months)

Incidence of SAEs

Intervention	participants (Number)
	Any TEAE leading to drug withdrawal	Any related TEAE leading to drug withdrawal
Placebo	6	2
PXT3003 Dose 1	6	3
PXT3003 Dose 2	6	2

Safety and tolerability of PXT3003 were compared to placebo on the incidence of serious adverse events (SAEs). (NCT02579759)
Timeframe: The period between the patient signing the informed consent and 30 days after the end of study (i.e. completion/early discontinuation/last contact as recorded on the 'Study Completion on Early Termination' form up to 15 months).

Mean of Ten Meter Walking Test (10MWT)

Intervention	participants (Number)
	Any serious TEAE	Any related serious TEAE	Any serious TEAE leading to drug withdrawal
Placebo	5	0	0
PXT3003 Dose 1	10	0	1
PXT3003 Dose 2	3	0	0

"This outcome measure is the mean of the available 10MWT values at month 12 and month 15.~The 10MWT is a simple to administer, standardized, reliable and valid evaluation of functional exercise capacity and gait that has been used to evaluate neurologic disorders and CMT patients.~Lower Time to Walk 10 Meters values indicate a better clinical condition.~Reported values are the values at Baseline (Base) and the average of the available values at Month 12 and Month 15 (Fin)." (NCT02579759)
Timeframe: From Baseline to Month 15

Mean of the CMTNS-v2 Examination Score (CMTES-v2)

Intervention	Seconds (s) (Mean)
	Base	Fin
Placebo	7.28	6.91
PXT3003 Dose 1	6.93	6.47
PXT3003 Dose 2	7.14	6.52

"This outcome measure is the mean of the available CMTNS-v2 Examination Score values at month 12 and month 15.~The CMTNS-v2 is a specific scale designed to assess severity of impairment in CMT disease. It is a 36-point scale based on nine items to quantify impairment (sensory symptoms, pin sensibility, vibration and arm and leg strength), activity limitations (motor symptoms arms and legs) and electrophysiological function (amplitudes of ulnar CMAP and SNAP). The CMTNS-v2 goes from 0 (no impairment) to 36 (maximum impairment) whom each sub-items goes from 0 to 4.~The CMTES-v2 is summed of item 1 to 7 of the CMTNS-v2 (limited to impairment items and excluding electrophysiological items). It is a 28-point score: 0 (no impairment) to 28 (maximum impairment).~Lower CMTES-v2 values indicate a better clinical condition.~Reported values are the values at Baseline (Base) and the average of the available values at Month 12 and Month 15 (Fin)." (NCT02579759)
Timeframe: From Baseline to Month 15

Mean of the CMTNS-v2 Sensory Score

Intervention	Scores on the CMTES-v2 (Mean)
	Base	Fin
Placebo	9.51	9.02
PXT3003 Dose 1	9.49	9.01
PXT3003 Dose 2	8.78	8.24

"This outcome measure is the mean of the available CMTNS-v2 Sensory Score values at month 12 and month 15.~The CMTNS-v2 is a specific scale designed to assess severity of impairment in CMT disease. It is a 36-point scale based on nine items to quantify impairment (sensory symptoms, pin sensibility, vibration and arm and leg strength), activity limitations (motor symptoms arms and legs) and electrophysiological function (amplitudes of ulnar CMAP and SNAP). The CMTNS-v2 goes from 0 (no impairment) to 36 (maximum impairment) whom each sub-items goes from 0 to 4.~The CMTNS-v2 Sensory score is summed of items 1+4+5 of CMTNS-v2 (Sensory symptoms, Pinprick sensibility and Vibration). It is a 12-point score: 0 (no impairment) to 12 (maximum impairment).~Lower CMTNS-v2 Sensory Score values indicate a better clinical condition.~Reported values are the values at Baseline (Base) and the average of the available values at Month 12 and Month 15 (Fin)." (NCT02579759)
Timeframe: From Baseline to Month 15

Mean of the CMTNS-v2 Sensory Symptoms

Intervention	Scores on the CMTNS-v2 Sensory Score (Mean)
	Base	Fin
Placebo	4.97	4.68
PXT3003 Dose 1	5.00	4.55
PXT3003 Dose 2	4.47	4.23

"This outcome measure is the mean of the available CMTNS-v2 Sensory Symptoms values at month 12 and month 15.~The CMTNS-v2 is a specific scale designed to assess severity of impairment in CMT disease. It is a 36-point scale based on nine items to quantify impairment (sensory symptoms, pin sensibility, vibration and arm and leg strength), activity limitations (motor symptoms arms and legs) and electrophysiological function (amplitudes of ulnar CMAP and SNAP). The CMTNS-v2 goes from 0 (no impairment) to 36 (maximum impairment) whom each sub-items goes from 0 to 4.~The CMTNS-v2 Sensory Symptoms is the first item of the CMTNS-v2. It is a 4-point score: 0 (no impairment) to 4 (maximum impairment).~Lower CMTNS-v2 Sensory Symptoms values indicate a better clinical condition.~Reported values are the values at Baseline (Base) and the average of the available values at Month 12 and Month 15 (Fin)." (NCT02579759)
Timeframe: From Baseline to Month 15

Mean of the Results at the Nine-Hole Peg Test (9-HPT)

Intervention	Scores on the CMTNS-v2 Sensory Symptoms (Mean)
	Base	Fin
Placebo	1.09	1.21
PXT3003 Dose 1	1.26	1.18
PXT3003 Dose 2	0.96	0.93

"This outcome measure is the mean of the available 9-HPT values at month 12 and month 15.~The Nine-Hole Peg Test (9HPT) is a simple timed test of fine motor coordination of extremitied in the upper limbs. It measures the time needed by the patient to insert 9 pegs in nine holes and to remove them (normal required time 18 seconds).~Lower 9HPT values indicate a better clinical condition.~Reported values are the values at Baseline (Base) and the average of the available values at Month 12 and Month 15 (Fin)." (NCT02579759)
Timeframe: From Baseline to Month 15

Number of Subjects With at Least One TEAE

Intervention	Seconds (s) (Mean)
	Base	Fin
Placebo	25.18	24.41
PXT3003 Dose 1	25.62	23.85
PXT3003 Dose 2	27.33	25.67

"Safety selection was to include all randomized patients that have received at least one dose of study treatment.~Safety and tolerability of PXT3003 were compared to placebo on the incidence of treatment-emergent adverse events (TEAEs); they were evaluated by type/nature, severity/intensity, seriousness, and relationship to study drug." (NCT02579759)
Timeframe: The period between the patient signing the informed consent and 30 days after the end of study (i.e. completion/early discontinuation/last contact as recorded on the 'Study Completion on Early Termination' form up to 15 months)

Overall Neuropathy Limitation Scale (ONLS) Total Score

Intervention	participants (Number)
	Any TEAE	Any related TEAE	Any moderately severe or severe related TEAE
Placebo	83	34	10
PXT3003 Dose 1	89	39	8
PXT3003 Dose 2	87	38	5

"The primary efficacy variable used in the main analysis is the mean of the available ONLS values at month 12 and month 15.~The ONLS is a disability scale that was derived and improved from the Overall Disability Sum Score (ODSS) to measure limitations in the everyday activities of the upper limbs (rated on 5 points) and the lower limbs (rated on 7 points). The total score is a 12-point scale: 0 (no disability) to 12 (maximum disability). Lower values in the ONLS indicate a better clinical condition.~Reported values are the values at Baseline (Base) and the average of the available values at Month 12 and Month 15 (Fin)." (NCT02579759)
Timeframe: From Baseline to Month 15

Plasma Concentrations of 6β-naltrexol at Trough and at 90 Min After Drug Intake

Intervention	Scores on the ONLS (Mean)
	Base	Fin
Placebo	3.23	3.36
PXT3003 Dose 1	3.33	3.25
PXT3003 Dose 2	3.05	2.82

"Plasma concentration of PXT3003 components were measured at trough (prior to dose) and peak (90 minutes post dose).~The mean plasma values of the baseline correspond to half of the administered dose." (NCT02579759)
Timeframe: At Month 12 and Month 15

Plasma Concentrations of Baclofen at Trough and at 90 Min After Drug Intake

Intervention	pg/mL (Mean)
	At trough, at Month 12	At trough, at Month 15	At 90 min after drug intake, at Month 12	At 90 min after drug intake, at Month 15
PXT3003 Dose 1	290.1	260.4	632.5	586.4
PXT3003 Dose 2	526.4	352.3	1257.1	1450.9

"Plasma concentration of PXT3003 components were measured at trough (prior to dose) and 90 minutes after drug intake.~The mean plasma values of the baseline correspond to half of the administered dose." (NCT02579759)
Timeframe: At Month 12 and Month 15

Plasma Concentrations of Naltrexone at Trough and at 90 Min After Drug Intake

Intervention	pg/mL (Mean)
	At trough, at Month 12	At trough, at Month 15	At 90 min after drug intake, at Month 12	At 90 min after drug intake, at Month 15
PXT3003 Dose 1	13739.3	9009.7	52201.6	47021.1
PXT3003 Dose 2	11651.9	8686.6	90238.7	105825.4

Alcohol Craving in Response to the Alcohol Cue Script

Intervention	pg/mL (Mean)
	At trough, at Month 12	At trough, at Month 15	At 90 min after drug intake, at Month 12	At 90 min after drug intake, at Month 15
PXT3003 Dose 1	33.0	31.8	63.0	55.0
PXT3003 Dose 2	42.0	30.0	107.5	130.9

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). (NCT01187511)
Timeframe: 15 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period

Alcohol Craving in Response to the Alcohol Cue Script

Intervention	Units on a scale (Least Squares Mean)
GSK561679	11.6932
Placebo	14.6126

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). (NCT01187511)
Timeframe: 15 minutes prior to the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period

Alcohol Craving in Response to the Alcohol Cue Script

Intervention	Units on a scale (Least Squares Mean)
GSK561679	8.7646
Placebo	10.413

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). (NCT01187511)
Timeframe: 30 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period

Alcohol Craving in Response to the Alcohol Cue Script

Intervention	Units on a scale (Least Squares Mean)
GSK561679	11.4075
Placebo	13.0412

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). (NCT01187511)
Timeframe: 45 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period

Alcohol Craving in Response to the Alcohol Cue Script

Intervention	Units on a scale (Least Squares Mean)
GSK561679	9.6218
Placebo	12.1841

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). (NCT01187511)
Timeframe: 5 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period

Alcohol Craving in Response to the Alcohol Cue Script

Intervention	Units on a scale (Least Squares Mean)
GSK561679	13.9789
Placebo	15.946

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). (NCT01187511)
Timeframe: 60 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period

Alcohol Craving in Response to the Alcohol Cue Script

Intervention	Units on a scale (Least Squares Mean)
GSK561679	9.9075
Placebo	12.1841

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). (NCT01187511)
Timeframe: 75 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period

Alcohol Craving in Response to the Alcohol Cue Script

Intervention	Units on a scale (Least Squares Mean)
GSK561679	9.6218
Placebo	11.6603

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). (NCT01187511)
Timeframe: 90 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period

Alcohol Craving in Response to the Stress Script

Intervention	Units on a scale (Least Squares Mean)
GSK561679	8.9075
Placebo	13.1841

Intervention	Units on a scale (Least Squares Mean)
GSK561679	12.1376
Placebo	13.1086

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). (NCT01187511)
Timeframe: 15 minutes prior to the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period

Alcohol Craving in Response to the Stress Script

Intervention	Units on a scale (Least Squares Mean)
GSK561679	9.7805
Placebo	10.6194

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). (NCT01187511)
Timeframe: 30 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period

Alcohol Craving in Response to the Stress Script

Intervention	Units on a scale (Least Squares Mean)
GSK561679	11.7091
Placebo	13.1432

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). (NCT01187511)
Timeframe: 45 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period

Alcohol Craving in Response to the Stress Script

Intervention	Units on a scale (Least Squares Mean)
GSK561679	11.3519
Placebo	12.1432

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). (NCT01187511)
Timeframe: 5 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period

Alcohol Craving in Response to the Stress Script

Intervention	Units on a scale (Least Squares Mean)
GSK561679	14.1376
Placebo	16.9051

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). (NCT01187511)
Timeframe: 60 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period

Alcohol Craving in Response to the Stress Script

Intervention	Units on a scale (Least Squares Mean)
GSK561679	11.2805
Placebo	12.0956

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). (NCT01187511)
Timeframe: 75 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period

Alcohol Craving in Response to the Stress Script

Intervention	Units on a scale (Least Squares Mean)
GSK561679	12.2091
Placebo	10.3813

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). (NCT01187511)
Timeframe: 90 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period

Alcohol Craving in Response to the Trier/Cue-reactivity Procedure

Intervention	Units on a scale (Least Squares Mean)
GSK561679	13.1376
Placebo	10.0004

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). (NCT01187511)
Timeframe: 100 minutes after the beginning of the Trier/cue-reactivity procedure, which occurred on Day 21 of the treatment period

Alcohol Craving in Response to the Trier/Cue-reactivity Procedure

Intervention	Units on a scale (Least Squares Mean)
GSK561679	12.977
Placebo	12.0475

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). (NCT01187511)
Timeframe: 15 minutes prior to the beginning of the Trier/cue-reactivity procedure, which occurred on Day 21 of the treatment period

Alcohol Craving in Response to the Trier/Cue-reactivity Procedure

Intervention	Units on a scale (Least Squares Mean)
GSK561679	15.1645
Placebo	12.0116

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). (NCT01187511)
Timeframe: 20 minutes after the beginning of the Trier/cue-reactivity procedure, which occurred on Day 21 of the treatment period

Alcohol Craving in Response to the Trier/Cue-reactivity Procedure

Intervention	Units on a scale (Least Squares Mean)
GSK561679	18.4145
Placebo	15.2497

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). (NCT01187511)
Timeframe: 40 minutes after the beginning of the Trier/cue-reactivity procedure, which occurred on Day 21 of the treatment period

Alcohol Craving in Response to the Trier/Cue-reactivity Procedure

Intervention	Units on a scale (Least Squares Mean)
GSK561679	20.352
Placebo	18.0116

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). (NCT01187511)
Timeframe: 70 minutes after the beginning of the Trier/cue-reactivity procedure, which occurred on Day 21 of the treatment period

Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period

Intervention	Units on a scale (Least Squares Mean)
GSK561679	13.7895
Placebo	13.0592

Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity). (NCT01187511)
Timeframe: Day 1 of the treatment period

Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period

Intervention	Units on a scale (Least Squares Mean)
GSK561679	7.8582
Placebo	8.7076

Intervention	Units on a scale (Least Squares Mean)
GSK561679	6.4777
Placebo	7.041

Intervention	Units on a scale (Least Squares Mean)
GSK561679	6.5443
Placebo	6.6122

Intervention	Units on a scale (Least Squares Mean)
GSK561679	6.011
Placebo	5.4219

Intervention	Units on a scale (Least Squares Mean)
GSK561679	6.611
Placebo	5.7835

Intervention	Units on a scale (Least Squares Mean)
GSK561679	5.3112
Placebo	5.1362

Depression Symptom Ratings Measured Bi-weekly During the Treatment Period

Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity). (NCT01187511)
Timeframe: Day 1 of the treatment period

Depression Symptom Ratings Measured Bi-weekly During the Treatment Period

Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period

Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value). (NCT01187511)
Timeframe: Day 1 of the treatment period

Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period

Alcohol Craving in Response to the Alcohol Cue Script

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). (NCT01227980)
Timeframe: 15 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period

Alcohol Craving in Response to the Alcohol Cue Script

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). (NCT01227980)
Timeframe: 15 minutes prior to the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period

Alcohol Craving in Response to the Alcohol Cue Script

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). (NCT01227980)
Timeframe: 30 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period

Alcohol Craving in Response to the Alcohol Cue Script

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). (NCT01227980)
Timeframe: 45 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period

Alcohol Craving in Response to the Alcohol Cue Script

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). (NCT01227980)
Timeframe: 5 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period

Alcohol Craving in Response to the Alcohol Cue Script

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). (NCT01227980)
Timeframe: 60 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period

Alcohol Craving in Response to the Alcohol Cue Script

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). (NCT01227980)
Timeframe: 75 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period

Alcohol Craving in Response to the Alcohol Cue Script

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). (NCT01227980)
Timeframe: 90 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period

Alcohol Craving in Response to the Stress Script

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). (NCT01227980)
Timeframe: 15 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period

Alcohol Craving in Response to the Stress Script

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). (NCT01227980)
Timeframe: 15 minutes prior to the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period

Alcohol Craving in Response to the Stress Script

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). (NCT01227980)
Timeframe: 30 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period

Alcohol Craving in Response to the Stress Script

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). (NCT01227980)
Timeframe: 45 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period

Alcohol Craving in Response to the Stress Script

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). (NCT01227980)
Timeframe: 5 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period

Alcohol Craving in Response to the Stress Script

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). (NCT01227980)
Timeframe: 60 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period

Alcohol Craving in Response to the Stress Script

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). (NCT01227980)
Timeframe: 75 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period

Alcohol Craving in Response to the Stress Script

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value). (NCT01227980)
Timeframe: 90 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period

Alcohol Craving Rating in Response to Meta-Chlorophenylpiperazine

Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). It is a 5-item self-administered instrument that measures frequency, intensity, and duration of thoughts about drinking, along with ability to resist drinking. There is a single outcome score than ranges from 0 to 30, with 30 being the maximum amount of alcohol craving. (NCT00605904)
Timeframe: 180 minutes after the start of the infusion

Alcohol Craving Rating in Response to Saline Infusion

Alcohol Craving Rating in Response to Yohimbine Infusion

Article	Year
The development of medications for alcohol-use disorders targeting the GABAB receptor system. Recent patents on CNS drug discovery, 2012, Volume: 7, Issue:2 Topics: Alcohol-Related Disorders; Allosteric Regulation; Animals; Baclofen; Disease Models, Animal; GABA-B	2012
Is baclofen a revolutionary medication in alcohol addiction management? Review and recent updates. Substance abuse, 2012, Volume: 33, Issue:4 Topics: Alcoholism; Animals; Baclofen; Behavior, Addictive; Clinical Trials as Topic; Disease Management; Di	2012
Pharmacological treatment of alcohol dependence: target symptoms and target mechanisms. Pharmacology & therapeutics, 2006, Volume: 111, Issue:3 Topics: Acamprosate; Alcohol Deterrents; Alcoholism; Animals; Baclofen; Corticotropin-Releasing Hormone; Dis	2006
Pharmacological treatment of alcohol dependence: target symptoms and target mechanisms. Pharmacology & therapeutics, 2006, Volume: 111, Issue:3 Topics: Acamprosate; Alcohol Deterrents; Alcoholism; Animals; Baclofen; Corticotropin-Releasing Hormone; Dis	2006
Pharmacological treatment of alcohol dependence: target symptoms and target mechanisms. Pharmacology & therapeutics, 2006, Volume: 111, Issue:3 Topics: Acamprosate; Alcohol Deterrents; Alcoholism; Animals; Baclofen; Corticotropin-Releasing Hormone; Dis	2006
Pharmacological treatment of alcohol dependence: target symptoms and target mechanisms. Pharmacology & therapeutics, 2006, Volume: 111, Issue:3 Topics: Acamprosate; Alcohol Deterrents; Alcoholism; Animals; Baclofen; Corticotropin-Releasing Hormone; Dis	2006
Pharmacological treatment of alcohol dependence: target symptoms and target mechanisms. Pharmacology & therapeutics, 2006, Volume: 111, Issue:3 Topics: Acamprosate; Alcohol Deterrents; Alcoholism; Animals; Baclofen; Corticotropin-Releasing Hormone; Dis	2006
Pharmacological treatment of alcohol dependence: target symptoms and target mechanisms. Pharmacology & therapeutics, 2006, Volume: 111, Issue:3 Topics: Acamprosate; Alcohol Deterrents; Alcoholism; Animals; Baclofen; Corticotropin-Releasing Hormone; Dis	2006
Pharmacological treatment of alcohol dependence: target symptoms and target mechanisms. Pharmacology & therapeutics, 2006, Volume: 111, Issue:3 Topics: Acamprosate; Alcohol Deterrents; Alcoholism; Animals; Baclofen; Corticotropin-Releasing Hormone; Dis	2006
Pharmacological treatment of alcohol dependence: target symptoms and target mechanisms. Pharmacology & therapeutics, 2006, Volume: 111, Issue:3 Topics: Acamprosate; Alcohol Deterrents; Alcoholism; Animals; Baclofen; Corticotropin-Releasing Hormone; Dis	2006
Pharmacological treatment of alcohol dependence: target symptoms and target mechanisms. Pharmacology & therapeutics, 2006, Volume: 111, Issue:3 Topics: Acamprosate; Alcohol Deterrents; Alcoholism; Animals; Baclofen; Corticotropin-Releasing Hormone; Dis	2006
Pharmacologic strategies in the treatment of experimental spinal cord injury. Journal of neurotrauma, 1992, Volume: 9 Suppl 1 Topics: 4-Aminopyridine; Animals; Baclofen; Disease Models, Animal; Gangliosides; Humans; Lipid Peroxidation	1992
Effects of different classes of antiepileptic drugs on brain-stem pathways. Federation proceedings, 1985, Volume: 44, Issue:8 Topics: Animals; Anticonvulsants; Baclofen; Brain Stem; Carbamazepine; Disease Models, Animal; Electroshock;	1985