gamma-aminobutyric acid and Asthenia studies

gamma-Aminobutyric Acid: The most common inhibitory neurotransmitter in the central nervous system.
gamma-aminobutyric acid : A gamma-amino acid that is butanoic acid with the amino substituent located at C-4.

Asthenia: Clinical sign or symptom manifested as debility, or lack or loss of strength and energy.

Research Excerpts

Excerpt	Relevance	Reference
"This randomised, double-blind study compared the newer antiepileptic drugs (AEDs) gabapentin (GBP) and lamotrigine (LTG) as monotherapy in newly diagnosed epilepsy."	9.10	Gabapentin versus lamotrigine monotherapy: a double-blind comparison in newly diagnosed epilepsy. ( Anhut, H; Brodie, MJ; Chadwick, DW; Garofalo, EA; Maton, S; Messmer, SL; Murray, G; Otte, A; Sauermann, W, 2002)
" During 2- and 6-week titration periods, respectively, GBP dosage reached 1,800 mg/day, and LTG, 150 mg/day."	6.70	Gabapentin versus lamotrigine monotherapy: a double-blind comparison in newly diagnosed epilepsy. ( Anhut, H; Brodie, MJ; Chadwick, DW; Garofalo, EA; Maton, S; Messmer, SL; Murray, G; Otte, A; Sauermann, W, 2002)
"This randomised, double-blind study compared the newer antiepileptic drugs (AEDs) gabapentin (GBP) and lamotrigine (LTG) as monotherapy in newly diagnosed epilepsy."	5.10	Gabapentin versus lamotrigine monotherapy: a double-blind comparison in newly diagnosed epilepsy. ( Anhut, H; Brodie, MJ; Chadwick, DW; Garofalo, EA; Maton, S; Messmer, SL; Murray, G; Otte, A; Sauermann, W, 2002)
" Patients of the first group received adaptol in dosage 1000 mg daily and patients of the second group received noofen in dosage 500 mg daily."	2.79	[Asthenic disorders in children and their differentiated treatment]. ( Anisimova, TI; Bondarchuk, IL; Chutko, LS; Iakovenko, EA; Nikishena, IS; Sergeev, AV; Surushkina, SI, 2014)
"The higher efficacy of adaptol in treatment of neurasthenia (80% in adolescents with neurasthenia and 60% of patients with residual asthenia) was shown."	2.79	[Asthenic disorders in children and their differentiated treatment]. ( Anisimova, TI; Bondarchuk, IL; Chutko, LS; Iakovenko, EA; Nikishena, IS; Sergeev, AV; Surushkina, SI, 2014)
"Authors examined 30 adolescents with neurasthenia and 30 with residual asthenia."	2.79	[Asthenic disorders in children and their differentiated treatment]. ( Anisimova, TI; Bondarchuk, IL; Chutko, LS; Iakovenko, EA; Nikishena, IS; Sergeev, AV; Surushkina, SI, 2014)
"Adolescents with neurasthenia were characterized by higher anxiety."	2.79	[Asthenic disorders in children and their differentiated treatment]. ( Anisimova, TI; Bondarchuk, IL; Chutko, LS; Iakovenko, EA; Nikishena, IS; Sergeev, AV; Surushkina, SI, 2014)
" During 2- and 6-week titration periods, respectively, GBP dosage reached 1,800 mg/day, and LTG, 150 mg/day."	2.70	Gabapentin versus lamotrigine monotherapy: a double-blind comparison in newly diagnosed epilepsy. ( Anhut, H; Brodie, MJ; Chadwick, DW; Garofalo, EA; Maton, S; Messmer, SL; Murray, G; Otte, A; Sauermann, W, 2002)
" Two analyses of adverse events are presented: tolerability and safety."	2.69	Safety and tolerability of gabapentin as adjunctive therapy in a large, multicenter study. ( Bernstein, P; Faught, RE; Holmes, GL; Magnus-Miller, L; McLean, MJ; Morrell, MJ; Privitera, MD; Rose-Legatt, A; Willmore, LJ, 1999)
" Within these 281 patients, two mutually exclusive groups were compared (a) those reporting adverse events at only < or =1,800 mg/day (low dose); and (b) those reporting adverse events at only >1,800 mg/day (high dose)."	2.69	Safety and tolerability of gabapentin as adjunctive therapy in a large, multicenter study. ( Bernstein, P; Faught, RE; Holmes, GL; Magnus-Miller, L; McLean, MJ; Morrell, MJ; Privitera, MD; Rose-Legatt, A; Willmore, LJ, 1999)
"Gabapentin doses >1,800 mg/day were as well tolerated as doses < or =1,800 mg/day and were not associated with more adverse events."	2.69	Safety and tolerability of gabapentin as adjunctive therapy in a large, multicenter study. ( Bernstein, P; Faught, RE; Holmes, GL; Magnus-Miller, L; McLean, MJ; Morrell, MJ; Privitera, MD; Rose-Legatt, A; Willmore, LJ, 1999)

Research

Studies (5)

Authors

Clinical Trials (1)

Trial Overview

Trial Outcomes

58-week Retention Rate Measured by the Number of Drop Outs Due to Adverse Events or Seizures From Day 1 of Treatment

Percentage of Patients Remaining Seizure Free at Week 58 (Visit 6)

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	1 (20.00)	18.2507
2000's	1 (20.00)	29.6817
2010's	3 (60.00)	24.3611
2020's	0 (0.00)	2.80

Authors	Studies
Chutko, LS	2
Surushkina, SI	1
Nikishena, IS	2
Iakovenko, EA	2
Anisimova, TI	2
Bondarchuk, IL	1
Sergeev, AV	1
Duma, SN	1
Shcherbakova, LV	1
Surushkina, SIu	1
Kuzovenkova, MP	1
Brodie, MJ	1
Chadwick, DW	1
Anhut, H	1
Otte, A	1
Messmer, SL	1
Maton, S	1
Sauermann, W	1
Murray, G	1
Garofalo, EA	1
McLean, MJ	1
Morrell, MJ	1
Willmore, LJ	1
Privitera, MD	1
Faught, RE	1
Holmes, GL	1
Magnus-Miller, L	1
Bernstein, P	1
Rose-Legatt, A	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
A Multicentre, Double-blind, Randomized, Phase IV Clinical Trial Comparing the Safety, Tolerability and Efficacy of Levetiracetam Versus Lamotrigine and Carbamazepine in the Oral Antiepileptic Therapy of Newly Diagnosed Elderly Patients With Focal Epileps[NCT00438451]	Phase 4	361 participants (Actual)	Interventional	2007-01-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Intervention	proportion of participants (Mean)
Levetiracetam	0.61
Carbamazepine	0.46
Lamotrigine	0.56

Percentage of patients experiencing no seizures until week 58 (Visit 6) and did not discontinue the study until week 58. (NCT00438451)
Timeframe: week 58

Percentage of Patients Remaining Seizure-free at Week 30 (Visit 4)

Intervention	percentage of participants (Number)
Levetiracetam	43
Carbamazepine	33
Lamotrigine	38

Percentage of patients experiencing no seizures until week 30 (Visit 4) and did not discontinue the study until week 30. (NCT00438451)
Timeframe: Week 30

Proportion of Seizure-free Days During the Maintenance Phase for Subjects Who Enter the Maintenance Phase

Results of Cognitive Testing (EpiTrack© by UCB) - Score at V6

Intervention	percentage of participants (Number)
Levetiracetam	48
Carbamazepine	39
Lamotrigine	49

Intervention	proportion of seizure-free days (Number)
Levetiracetam	0.99
Carbamazepine	0.99
Lamotrigine	0.99

EPITrack-Score shows the performance of attention and executive functions. Higher values indicate a better performance. The results of EPITrack Score ranges between 7 and 45. (NCT00438451)
Timeframe: week 58

The Absolute Seizure Frequency During the Maintenance Phase (Weeks 7 - 58)

Intervention	units on a scale (Mean)
Levetiracetam	26.0
Carbamazepine	26.0
Lamotrigine	25.4

"Seizure frequency was assessed by investigators in the CRF at the Visits V3, V4, V5 and V6.~The absolute seizure frequency during the maintenance phase was defined as the sum of those entries." (NCT00438451)
Timeframe: over 52 weeks

The Time (in Days) to First Break-through Seizure (From Day 1 of Treatment)

Time to Drop Out

Intervention	number of seizures (Number)
Levetiracetam	168
Carbamazepine	131
Lamotrigine	130

Intervention	days (Median)
Levetiracetam	NA
Carbamazepine	NA
Lamotrigine	NA

number of days between randomization and premature discontinuation of the study (NCT00438451)
Timeframe: 58 weeks

Portland Neurotoxicity Scale (PNS) at V6

Intervention	days (Median)
Levetiracetam	NA
Carbamazepine	265
Lamotrigine	NA

"The PNS is a 15-item scale. Each item can be scored from 1 to 9. There are a total score (includes all items, range:15 to 135) and two subscores: The cognitive toxicity subscore (10 items: Energy Level, Memory, Interest, Concentration, Forgetfulness, Sleepliness, Moodiness, Alertness, Attention Span, Motivation, range:10 to 90) and the somatomoto subscore (5 items: Vision, Walking, Coordination, Tremor, Speech, range:5-45). The score is calculated by taking the mean of all non-missing values times the number of items.~Lower values indicate better quality of life." (NCT00438451)
Timeframe: at week 58

QOLIE-31 (Quality Of Life In Epilepsy) Results at V6

Intervention	units on a scale (Mean)
	Cognitive toxicity subscore	Somatomotor subscore	Total Score
Carbamazepine	27.3	11.4	38.7
Lamotrigine	23.7	10.8	34.5
Levetiracetam	22.2	10.5	32.7

The QOLIE-31 is a 31 item score that measures the quality of life in epilepsy (each item with a range of 0 to 100). There are 7 sub-scores seizure worry (items 11,21,22,23,25), overall quality of life (items 1,14), emotional well-being (items 3,4,5,7,9), energy/fatigue (items 2,6,8,10), cognitive functioning (items 12,15,16,17,18,26), medication effects (items 24,29,30) and social functioning (13,19,20,27,28). These scores were combined to a total score by Total score = seizure worry*0.08 + overall quality of life*0.14 + emotional well-being*0.15 + energy/fatigue*0.12 + cognitive functioning*0.27 + medication effects*0.03 + social functioning*0.21 For all scores, higher values indicate better quality of life. Each score has a possible range from 0 to 100. (NCT00438451)
Timeframe: 58 weeks, final visit

Intervention	units on a scale (Mean)
	Seizure worry	Overall quality of life	Emotional well-being	Energy/fatigue	Cognitive functioning	Medication effects	Social functioning	Total Score	Health Scale
Carbamazepine	75.4	65.0	69.8	54.5	68.9	70.6	76.3	68.9	65.7
Lamotrigine	75.0	67.1	67.4	59.8	68.0	72.6	76.7	69.1	67.5
Levetiracetam	85.1	67.2	72.0	60.8	75.1	77.6	81.1	73.9	69.5

"Evaluation of current testing at V6:~≥29 score points: Inconspicuous; 26 to 28 score points: Borderline;~≤25 score points: Impaired" (NCT00438451)
Timeframe: 58 weeks

Intervention	participants (Number)
	Without pathological findings	Borderline	Impaired
Carbamazepine	34	17	33
Lamotrigine	31	15	39
Levetiracetam	38	10	36

"Evaluation of Changes~Changes in the EpiTrack® Score were categorized as follows:~≥5 score points: Improved;~-3 to 4 score points: Unchanged;~≤-4 score points: Worsened" (NCT00438451)
Timeframe: week 58

Article	Year
[Asthenic disorders in children and their differentiated treatment]. Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova, 2014, Volume: 114, Issue:12 Topics: Adolescent; Anti-Anxiety Agents; Anxiety; Asthenia; Biureas; Fatigue; Female; GABA Agonists; gamma-A	2014
[Diagnosis and treatment of psychogenic dizziness in patients with arterial hypertension]. Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova, 2016, Volume: 116, Issue:2 Topics: Aged; Anxiety; Asthenia; Betahistine; Dizziness; Female; gamma-Aminobutyric Acid; Humans; Hypertensi	2016
[Asthenic disorders in children]. Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova, 2010, Volume: 110, Issue:11 Pt 1 Topics: Adolescent; Asthenia; Biureas; Child; gamma-Aminobutyric Acid; Humans; Neurasthenia; Pantothenic Aci	2010
Gabapentin versus lamotrigine monotherapy: a double-blind comparison in newly diagnosed epilepsy. Epilepsia, 2002, Volume: 43, Issue:9 Topics: Acetates; Adolescent; Adult; Aged; Amines; Anticonvulsants; Asthenia; Clinical Protocols; Cyclohexan	2002
Safety and tolerability of gabapentin as adjunctive therapy in a large, multicenter study. Epilepsia, 1999, Volume: 40, Issue:7 Topics: Acetates; Adolescent; Adult; Ambulatory Care; Amines; Anticonvulsants; Asthenia; Carbamazepine; Cycl	1999

gamma-aminobutyric acid and Asthenia