Page last updated: 2024-10-22

antipyrine and ALS - Amyotrophic Lateral Sclerosis

antipyrine has been researched along with ALS - Amyotrophic Lateral Sclerosis in 38 studies

Antipyrine: An analgesic and antipyretic that has been given by mouth and as ear drops. Antipyrine is often used in testing the effects of other drugs or diseases on drug-metabolizing enzymes in the liver. (From Martindale, The Extra Pharmacopoeia, 30th ed, p29)
antipyrine : A pyrazolone derivative that is 1,2-dihydropyrazol-3-one substituted with methyl groups at N-1 and C-5 and with a phenyl group at N-2.

Research Excerpts

ExcerptRelevanceReference
"Edaravone slowed the rate of functional decline in subjects with amyotrophic lateral sclerosis (ALS) in phase 3 study MCI186-19 (Study 19)."9.51Edaravone efficacy in amyotrophic lateral sclerosis with reduced forced vital capacity: Post-hoc analysis of Study 19 (MCI186-19) [clinical trial NCT01492686]. ( Apple, S; Brooks, BR; Heiman-Patterson, T; Liu, S; Wiedau-Pazos, M; Zhang, J, 2022)
"In a previous phase 3 study in patients with amyotrophic lateral sclerosis (ALS), edaravone did not show a significant difference in the Revised ALS Functional Rating Scale (ALSFRS-R) score compared with placebo."9.24Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. ( , 2017)
"Our objective was to explore the efficacy and safety of edaravone in amyotrophic lateral sclerosis (ALS) patients with a Japan ALS severity classification of Grade 3."9.24Exploratory double-blind, parallel-group, placebo-controlled study of edaravone (MCI-186) in amyotrophic lateral sclerosis (Japan ALS severity classification: Grade 3, requiring assistance for eating, excretion or ambulation). ( , 2017)
"Our first phase III study failed to demonstrate efficacy of edaravone for amyotrophic lateral sclerosis (ALS) compared to placebo."9.24A post-hoc subgroup analysis of outcomes in the first phase III clinical study of edaravone (MCI-186) in amyotrophic lateral sclerosis. ( , 2017)
"Following the first phase III study of edaravone for amyotrophic lateral sclerosis (ALS), this extension study was performed to evaluate longer-term efficacy and safety."9.24Exploratory double-blind, parallel-group, placebo-controlled extension study of edaravone (MCI-186) in amyotrophic lateral sclerosis. ( , 2017)
"Compared to age-matched healthy controls (n = 55), patients with amyotrophic lateral sclerosis (ALS) (n = 26) showed increased oxidative stress as indicated by a significantly increased percentage of oxidized coenzyme Q10 (%CoQ10) in total plasma coenzyme Q10, a significantly decreased level of plasma uric acid, and a significantly decreased percentage of polyunsaturated fatty acids in total plasma free fatty acids (FFA)."9.22Increased oxidative stress in patients with amyotrophic lateral sclerosis and the effect of edaravone administration. ( Miyazaki, Y; Nagase, M; Yamamoto, Y; Yoshino, H, 2016)
"Our objective was to confirm the efficacy and safety of edaravone in amyotrophic lateral sclerosis (ALS) patients."9.19Confirmatory double-blind, parallel-group, placebo-controlled study of efficacy and safety of edaravone (MCI-186) in amyotrophic lateral sclerosis patients. ( Abe, K; Akimoto, M; Aoki, M; Doyu, M; Hamada, C; Itoyama, Y; Kondo, K; Sobue, G; Tsuji, S; Yoneoka, T; Yoshino, H, 2014)
"The free radical scavenger edaravone is a proven neuroprotective drug for patients with amyotrophic lateral sclerosis (ALS)."7.96Improvement of a decreased anti-oxidative activity by edaravone in amyotrophic lateral sclerosis patients. ( Abe, K; Hishikawa, N; Ikegami, K; Kawahara, Y; Matsumoto, N; Nakano, Y; Nomura, E; Ohta, Y; Omote, Y; Osakada, Y; Sasaki, R; Sato, K; Tadokoro, K; Takahashi, Y; Takamiya, M; Takemoto, M; Tsunoda, K; Yamashita, T; Yunoki, T, 2020)
"Edaravone was descriptively favoured for each ALSFRS-R item and each of the four ALSFRS-R domains at the end of cycle 6 (ALL LOCF), suggesting a generalised effect of edaravone in slowing functional decline across all anatomical regions."6.84Post-hoc analysis of randomised, placebo-controlled, double-blind study (MCI186-19) of edaravone (MCI-186) in amyotrophic lateral sclerosis. ( Liu, S; Palumbo, J; Takahashi, F; Takei, K; Tsuda, K, 2017)
" Endpoints included treatment-emergent adverse events (TEAEs), including AEs leading to discontinuation, serious adverse events (SAEs), and deaths."6.84A safety analysis of edaravone (MCI-186) during the first six cycles (24 weeks) of amyotrophic lateral sclerosis (ALS) therapy from the double-blind period in three randomized, placebo-controlled studies. ( Ishizaki, K; Kalin, A; Kim, A; Medina-Paraiso, E; Saita, T; Wasaki, M; Zhang, Y, 2017)
"Edaravone is a strong antioxidant that prevents oxidative stress from inducing motor neuron death in ALS patients."6.58Edaravone: a new hope for deadly amyotrophic lateral sclerosis. ( Bhandari, R; Kuhad, A, 2018)
"Edaravone, is a free-radical scavenger, it has been shown to inhibit motor neuron death in animal models by reducing oxidative stress & it has shown efficacy in a small subset of people with ALS."5.72Efficacy and Safety of Edaravone in Amyotrophic Lateral Sclerosis Patients in Indian Population. ( Gupta, S; Singal, A; Soni, R; Tomar, S, 2022)
"Edaravone slowed the rate of functional decline in subjects with amyotrophic lateral sclerosis (ALS) in phase 3 study MCI186-19 (Study 19)."5.51Edaravone efficacy in amyotrophic lateral sclerosis with reduced forced vital capacity: Post-hoc analysis of Study 19 (MCI186-19) [clinical trial NCT01492686]. ( Apple, S; Brooks, BR; Heiman-Patterson, T; Liu, S; Wiedau-Pazos, M; Zhang, J, 2022)
"In a previous phase 3 study in patients with amyotrophic lateral sclerosis (ALS), edaravone did not show a significant difference in the Revised ALS Functional Rating Scale (ALSFRS-R) score compared with placebo."5.24Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. ( , 2017)
"Our objective was to explore the efficacy and safety of edaravone in amyotrophic lateral sclerosis (ALS) patients with a Japan ALS severity classification of Grade 3."5.24Exploratory double-blind, parallel-group, placebo-controlled study of edaravone (MCI-186) in amyotrophic lateral sclerosis (Japan ALS severity classification: Grade 3, requiring assistance for eating, excretion or ambulation). ( , 2017)
"Our first phase III study failed to demonstrate efficacy of edaravone for amyotrophic lateral sclerosis (ALS) compared to placebo."5.24A post-hoc subgroup analysis of outcomes in the first phase III clinical study of edaravone (MCI-186) in amyotrophic lateral sclerosis. ( , 2017)
"Following the first phase III study of edaravone for amyotrophic lateral sclerosis (ALS), this extension study was performed to evaluate longer-term efficacy and safety."5.24Exploratory double-blind, parallel-group, placebo-controlled extension study of edaravone (MCI-186) in amyotrophic lateral sclerosis. ( , 2017)
"Compared to age-matched healthy controls (n = 55), patients with amyotrophic lateral sclerosis (ALS) (n = 26) showed increased oxidative stress as indicated by a significantly increased percentage of oxidized coenzyme Q10 (%CoQ10) in total plasma coenzyme Q10, a significantly decreased level of plasma uric acid, and a significantly decreased percentage of polyunsaturated fatty acids in total plasma free fatty acids (FFA)."5.22Increased oxidative stress in patients with amyotrophic lateral sclerosis and the effect of edaravone administration. ( Miyazaki, Y; Nagase, M; Yamamoto, Y; Yoshino, H, 2016)
"Our objective was to confirm the efficacy and safety of edaravone in amyotrophic lateral sclerosis (ALS) patients."5.19Confirmatory double-blind, parallel-group, placebo-controlled study of efficacy and safety of edaravone (MCI-186) in amyotrophic lateral sclerosis patients. ( Abe, K; Akimoto, M; Aoki, M; Doyu, M; Hamada, C; Itoyama, Y; Kondo, K; Sobue, G; Tsuji, S; Yoneoka, T; Yoshino, H, 2014)
"The free radical scavenger edaravone is a proven neuroprotective drug for patients with amyotrophic lateral sclerosis (ALS)."3.96Improvement of a decreased anti-oxidative activity by edaravone in amyotrophic lateral sclerosis patients. ( Abe, K; Hishikawa, N; Ikegami, K; Kawahara, Y; Matsumoto, N; Nakano, Y; Nomura, E; Ohta, Y; Omote, Y; Osakada, Y; Sasaki, R; Sato, K; Tadokoro, K; Takahashi, Y; Takamiya, M; Takemoto, M; Tsunoda, K; Yamashita, T; Yunoki, T, 2020)
"We evaluated a battery of functional tests for investigating the effects of edaravone, a free radical scavenger, in SOD1 transgenic (H46R) rat model of amyotrophic lateral sclerosis."3.77Feasibility study for functional test battery of SOD transgenic rat (H46R) and evaluation of edaravone, a free radical scavenger. ( Aoki, M; Itoyama, Y; Mizuno, H; Suzuki, N; Warita, H; Yuki, S, 2011)
"Edaravone was descriptively favoured for each ALSFRS-R item and each of the four ALSFRS-R domains at the end of cycle 6 (ALL LOCF), suggesting a generalised effect of edaravone in slowing functional decline across all anatomical regions."2.84Post-hoc analysis of randomised, placebo-controlled, double-blind study (MCI186-19) of edaravone (MCI-186) in amyotrophic lateral sclerosis. ( Liu, S; Palumbo, J; Takahashi, F; Takei, K; Tsuda, K, 2017)
" Endpoints included treatment-emergent adverse events (TEAEs), including AEs leading to discontinuation, serious adverse events (SAEs), and deaths."2.84A safety analysis of edaravone (MCI-186) during the first six cycles (24 weeks) of amyotrophic lateral sclerosis (ALS) therapy from the double-blind period in three randomized, placebo-controlled studies. ( Ishizaki, K; Kalin, A; Kim, A; Medina-Paraiso, E; Saita, T; Wasaki, M; Zhang, Y, 2017)
"Edaravone is a strong antioxidant that prevents oxidative stress from inducing motor neuron death in ALS patients."2.58Edaravone: a new hope for deadly amyotrophic lateral sclerosis. ( Bhandari, R; Kuhad, A, 2018)
" Questions regarding whether the dosing regimen could be simplified or improved, the duration of the effects, and the timing of the potential treatment to different stages of disease remain to be answered."2.55What can we learn from the edaravone development program for ALS? ( Maragakis, NJ, 2017)
"Edaravone has recently been approved as a new therapeutic option for ALS in Japan."2.53Novel therapies in development that inhibit motor neuron hyperexcitability in amyotrophic lateral sclerosis. ( Kiernan, MC; Noto, Y; Shibuya, K; Vucic, S, 2016)
"Edaravone, is a free-radical scavenger, it has been shown to inhibit motor neuron death in animal models by reducing oxidative stress & it has shown efficacy in a small subset of people with ALS."1.72Efficacy and Safety of Edaravone in Amyotrophic Lateral Sclerosis Patients in Indian Population. ( Gupta, S; Singal, A; Soni, R; Tomar, S, 2022)
"Edaravone is a free-radical scavenger, an agent being widely used for cerebral ischemia in Japan."1.35Treatment with edaravone, initiated at symptom onset, slows motor decline and decreases SOD1 deposition in ALS mice. ( Ito, H; Kaneko, S; Kusaka, H; Nakano, S; Ohnishi, S; Wate, R; Zhang, J, 2008)

Research

Studies (38)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's4 (10.53)29.6817
2010's29 (76.32)24.3611
2020's5 (13.16)2.80

Authors

AuthorsStudies
Tomar, S1
Gupta, S1
Singal, A1
Soni, R1
Brooks, BR1
Heiman-Patterson, T1
Wiedau-Pazos, M1
Liu, S2
Zhang, J2
Apple, S1
Park, JM1
Park, D1
Kim, HJ1
Park, JS1
Ohta, Y1
Yamashita, T1
Nomura, E1
Hishikawa, N1
Ikegami, K1
Osakada, Y1
Matsumoto, N1
Kawahara, Y1
Yunoki, T1
Takahashi, Y1
Takamiya, M1
Tadokoro, K1
Sasaki, R1
Nakano, Y1
Tsunoda, K1
Sato, K1
Omote, Y1
Takemoto, M1
Abe, K2
Sawada, H1
Hardiman, O2
van den Berg, LH2
Takei, K4
Watanabe, K1
Yuki, S2
Akimoto, M3
Sakata, T1
Palumbo, J4
Maragakis, NJ1
Takahashi, F3
Tsuda, K3
Kalin, A1
Medina-Paraiso, E1
Ishizaki, K1
Kim, A1
Zhang, Y1
Saita, T1
Wasaki, M1
Nakamura, K1
Mora, JS1
Tao, QQ1
Wu, ZY1
Al-Chalabi, A1
Andersen, PM1
Chandran, S1
Chio, A1
Corcia, P1
Couratier, P1
Danielsson, O1
de Carvalho, M1
Desnuelle, C1
Grehl, T1
Grosskreutz, J1
Holmøy, T1
Ingre, C1
Karlsborg, M1
Kleveland, G1
Koch, JC1
Koritnik, B1
KuzmaKozakiewicz, M1
Laaksovirta, H1
Ludolph, A1
McDermott, C1
Meyer, T1
Mitre Ropero, B1
Mora Pardina, J1
Nygren, I1
Petri, S1
Povedano Panades, M1
Salachas, F1
Shaw, P1
Silani, V1
Staaf, G1
Svenstrup, K1
Talbot, K1
Tysnes, OB1
Van Damme, P1
van der Kooi, A1
Weber, M1
Weydt, P1
Wolf, J1
Scott, A1
Rothstein, JD1
Yeo, CJJ1
Simmons, Z1
Bhandari, R1
Kuhad, A2
Genge, A1
Brooks, B1
Itoyama, Y2
Sobue, G1
Tsuji, S1
Aoki, M2
Doyu, M1
Hamada, C1
Kondo, K1
Yoneoka, T1
Yoshino, H3
Nagase, M1
Yamamoto, Y1
Miyazaki, Y1
Ikeda, K1
Iwasaki, Y1
Noto, Y1
Shibuya, K1
Vucic, S1
Kiernan, MC1
Martinez, A1
Palomo Ruiz, MD1
Perez, DI1
Gil, C1
Ito, H2
Wate, R1
Ohnishi, S1
Kaneko, S1
Nakano, S1
Kusaka, H1
Takahashi, R1
Warita, H1
Mizuno, H1
Suzuki, N1
Zona, C1
Pieri, M1
Carunchio, I1
Kimura, A1

Clinical Trials (8)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Interplay Between Gut Microbiota and Adaptive Immunity in Amyotrophic Lateral Sclerosis: a Clinical Trial[NCT03766321]42 participants (Actual)Interventional2020-07-01Active, not recruiting
Treatment Effect of Edaravone in Patients With Amyotrophic Lateral Sclerosis (ALS) in a Representative Iranian Population[NCT03272802]Phase 2/Phase 320 participants (Anticipated)Interventional2017-03-16Active, not recruiting
Efficacy and Safety Study of MCI-186 for Treatment of the Patients With Amyotrophic Lateral Sclerosis (ALS) 2[NCT01492686]Phase 3137 participants (Actual)Interventional2011-12-31Completed
Efficacy and Safety of Nerve Growth Factor or Edaravone on Alcohol-induced Brain Injury[NCT03968042]Phase 2150 participants (Anticipated)Interventional2019-06-30Recruiting
An Expanded Controlled Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis in Double-Blind, Parallel-Group, Placebo-Controlled Manner (Phase 3)[NCT00424463]Phase 3181 participants (Actual)Interventional2007-01-31Completed
An Exploratory Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (Severity Classification III) in Double-Blind, Parallel-Group, Placebo-Controlled Manner[NCT00415519]Phase 325 participants (Actual)Interventional2006-12-31Completed
Tolerability and Efficacy of L-Serine in Patients With Amyotrophic Lateral Sclerosis: A Phase IIa Study[NCT03580616]Phase 243 participants (Actual)Interventional2018-10-24Terminated (stopped due to Study was terminated by the IRB due to continued noncompliance.)
A Confirmatory Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis in Double-blind, Parallel-group, Placebo-controlled Manner.[NCT00330681]Phase 3206 participants (Actual)Interventional2006-05-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks

(NCT01492686)
Timeframe: baseline and 24 weeks

Interventionpercentage of FVC (Least Squares Mean)
MCI-186-15.61
Placebo of MCI-186-20.4

Change From Baseline in ALS Assessment Questionnaire (40 Items) (ALSAQ40) in Full Analysis Set (FAS) Population at 24 Weeks

The ALSAQ40 score is a measure of QoL for patients with ALS. The ALSAQ40 evaluates domains that include physical mobility, Activities of daily living (ADL) and independence, eating and drinking, communication, and emotional reactions. 200=worst; 40=best (NCT01492686)
Timeframe: baseline and 24 weeks

Interventionunits on a scale (Least Squares Mean)
MCI-18617.25
Placebo of MCI-18626.04

Change From Baseline in Modified Norris Scale Score in Full Analysis Set (FAS) Population at 24 Weeks

The Modified Norris Scale is a measure of movement disorder for patients with ALS. 0=worst; 102=best (NCT01492686)
Timeframe: baseline and 24 weeks

Interventionunits on a scale (Least Squares Mean)
MCI-186-15.91
Placebo of MCI-186-20.8

Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks

0=worst; 48=best (NCT01492686)
Timeframe: baseline and 24 weeks

Interventionunits on a scale (Least Squares Mean)
MCI-186-5.01
Placebo of MCI-186-7.5

Percentage of Participants With Adverse Drug Reactions

(NCT01492686)
Timeframe: 24 weeks

Interventionpercentage of Participants (Number)
MCI-1862.9
Placebo of MCI-1867.4

Percentage of Participants With Adverse Events

(NCT01492686)
Timeframe: 24 weeks

Interventionpercentage of Participants (Number)
MCI-18684.1
Placebo of MCI-18683.8

"Laboratory Tests Percentage of Participants With Adverse Events by System Organ Class (SOC) of Investigations (PT, MedDRA Ver. 17.0)"

(NCT01492686)
Timeframe: 24 weeks

,
Interventionpercentage of Participants (Number)
Blood bilirubin increasedBlood creatine phosphokinase increasedLiver function test abnormalWhite blood cell count decreased
MCI-186001.41.4
Placebo of MCI-1861.51.51.50

Number of Participants With Death or a Specified State of Disease Progression

"Any of death, disability of independent ambulation, loss of upper limbs function, tracheotomy, use of respirator, use of tube feeding and loss of useful speech was defined as an event." (NCT01492686)
Timeframe: 24 weeks

,
InterventionCount of Participants (Number)
DeathDisability of independent ambulationLoss of upper limbs functionTracheotomyUse of respiratorUse of tube feedingLoss of useful speech
MCI-1860001001
Placebo of MCI-1860200013

Percentage of Participants With Abnormal Values in Sensory Examinations

(NCT01492686)
Timeframe: baseline and 24 weeks

,
Interventionpercentage of Participants (Number)
Numbness (at baseline)Numbness (at 24 week)Staggering (at baseline)Staggering (at 24 week)
MCI-1862.97.21.42.9
Placebo of MCI-1867.49.48.83.1

Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks

To investigate the sustainability of effects of edaravone, the analysis focusing on the comparison between the placebo and edaravone groups of patients who had received 6 cycles of edaravone treatment, i.e., the comparison of data from Cycles 7 to 12 between the edaravone-edaravone group and the edaravone-placebo group, was performed. (NCT00424463)
Timeframe: baseline (seventh cycle) and at 24 week (twelfth cycle)

Interventionpercentage of FVC (Mean)
MCI-186 - Placebo of MCI-186-10.6
MCI-186 - MCI-186-12.91
Placebo of MCI-186 - MCI-186-10.54

Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks

0=worst; 48=best To investigate the sustainability of effects of edaravone, the analysis focusing on the comparison between the placebo and edaravone groups of patients who had received 6 cycles of edaravone treatment, i.e., the comparison of data from Cycles 7 to 12 between the edaravone-edaravone group and the edaravone-placebo group, was performed. (NCT00424463)
Timeframe: baseline (seventh cycle) and at 24 week (twelfth cycle)

Interventionunits on a scale (Mean)
MCI-186 - Placebo of MCI-186-5.5
MCI-186 - MCI-186-4.2
Placebo of MCI-186 - MCI-186-5.4

Percentage of Participants With Adverse Drug Reactions

(NCT00424463)
Timeframe: 36 weeks (from seventh cycle to fifteenth cycle)

Interventionpercentage of participant (Number)
MCI-186 - Placebo of MCI-1864.4
MCI-186 - MCI-18610.4
Placebo of MCI-186 - MCI-18610.2

Percentage of Participants With Adverse Events

(NCT00424463)
Timeframe: 36 weeks (from seventh cycle to fifteenth cycle)

Interventionpercentage of participant (Number)
MCI-186 - Placebo of MCI-18697.8
MCI-186 - MCI-18691.7
Placebo of MCI-186 - MCI-18692

Number of Participants With Death or a Specified State of Disease Progression

"Any of death, disability of independent ambulation, loss of upper arm function, tracheotomy, use of respirator, and use of tube feeding was defined as an event." (NCT00424463)
Timeframe: 24 weeks (from seventh cycle to twelfth cycle)

,,
InterventionParticipants (Count of Participants)
deathdisability of independent ambulationloss of upper arm functiontracheotomyuse of respiratoruse of tube feeding
MCI-186 - MCI-1861115011
MCI-186 - Placebo of MCI-186183001
Placebo of MCI-186 - MCI-1861207228

Percentage of Participants With Abnormal Changes in Sensory Examinations

(NCT00424463)
Timeframe: 36 weeks (from seventh cycle to fifteenth cycle)

,,
Interventionpercentage of participant (Number)
NumbnessStaggeringVibratory sensation
MCI-186 - MCI-18602.10
MCI-186 - Placebo of MCI-186000
Placebo of MCI-186 - MCI-18602.30

Percentage of Participants With Laboratory Tests for Which the Incidence of Abnormal Changes Was 5% or Higher in Either Group

(NCT00424463)
Timeframe: 36 weeks (from seventh cycle to fifteenth cycle)

,,
Interventionpercentage of participant (Number)
White blood cell countAlanine aminotransferaseUrinary glucose
MCI-186 - MCI-1864.26.36.3
MCI-186 - Placebo of MCI-18611.100
Placebo of MCI-186 - MCI-18610.24.53.4

Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks

No primary endpoint was used, because various exploratory analyses were performed. (NCT00415519)
Timeframe: baseline and 24 weeks

Interventionpercentage of FVC (Least Squares Mean)
MCI-186-18.75
Placebo of MCI-186-15.69

Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks

"No primary endpoint was used, because various exploratory analyses were performed.~0=worst; 48=best" (NCT00415519)
Timeframe: baseline and 24 weeks

Interventionunits on a scale (Least Squares Mean)
MCI-186-6.52
Placebo of MCI-186-6

Percentage of Participants With Adverse Drug Reactions

No primary endpoint was used, because various exploratory analyses were performed. (NCT00415519)
Timeframe: 24 weeks

Interventionpercentage of participants (Number)
MCI-18623.1
Placebo of MCI-1868.3

Percentage of Participants With Adverse Events

No primary endpoint was used, because various exploratory analyses were performed. (NCT00415519)
Timeframe: 24 weeks

Interventionpercentage of participants (Number)
MCI-18692.3
Placebo of MCI-186100

Death or a Specified State of Disease Progression

"No primary endpoint was used, because various exploratory analyses were performed.~Any of death, disability of independent ambulation, loss of upper arm function, tracheotomy, use of respirator, and use of tube feeding was defined as an event." (NCT00415519)
Timeframe: 24 weeks

,
Interventionevents (Number)
deathdisability of independent ambulationloss of upper arm functiontracheotomyuse of respiratoruse of tube feeding
MCI-186141001
Placebo of MCI-186022000

Percentage of Participants With Abnormal Changes in Sensory Examinations

No primary endpoint was used, because various exploratory analyses were performed. (NCT00415519)
Timeframe: 24 weeks

,
Interventionpercentage of participants (Number)
NumbnessStaggeringVibratory sensation
MCI-1860100
Placebo of MCI-186000

The Percentage of Participants With an Abnormal Change in Laboratory Tests That Occurred in More Than Two Patients

No primary endpoint was used, because various exploratory analyses were performed. (NCT00415519)
Timeframe: 24 weeks

,
Interventionpercentage of participants (Number)
White blood cell count (WBC)Other laboratory tests except for WBC
MCI-18623.10
Placebo of MCI-1868.30

Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks

(NCT00330681)
Timeframe: baseline and 24 weeks

Interventionpercentage of FVC (Least Squares Mean)
MCI-186-14.57
Placebo of MCI-186-17.49

Change From Baseline in ALS Assessment Questionnaire (40 Items) (ALSAQ40) in Full Analysis Set (FAS) Population at 24 Weeks

The ALSAQ40 score is a measure of QoL for patients with ALS. The ALSAQ40 evaluates domains that include physical mobility, ADL and independence, eating and drinking, communication, and emotional reactions. Worst=200, Best=40 (NCT00330681)
Timeframe: baseline and 24 weeks

Interventionunits on a scale (Least Squares Mean)
MCI-18619.6
Placebo of MCI-18619.13

Change From Baseline in Modified Norris Scale Score in Full Analysis Set (FAS) Population at 24 Weeks

The Modified Norris Scale is a measure of movement disorder for patients with ALS. Worst=0, Best=102 (NCT00330681)
Timeframe: baseline and 24 weeks

Interventionunits on a scale (Least Squares Mean)
MCI-186-14.12
Placebo of MCI-186-16.15

Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks

ALSFRS-R Score: 0=worst; 48=best (NCT00330681)
Timeframe: baseline and 24 weeks

Interventionunits on a scale (Least Squares Mean)
MCI-186-5.7
Placebo of MCI-186-6.35

Percentage of Participants With Adverse Drug Reactions

(NCT00330681)
Timeframe: 24 weeks

Interventionpercentage of participants (Number)
MCI-18613.7
Placebo of MCI-18619.2

Percentage of Participants With Adverse Events

(NCT00330681)
Timeframe: 24 weeks

Interventionpercentage of participants (Number)
MCI-18689.2
Placebo of MCI-18688.5

Death or a Specified State of Disease Progression

"Any of death, disability of independent ambulation, loss of upper arm function, tracheotomy, use of respirator, and use of tube feeding was defined as an event." (NCT00330681)
Timeframe: 24 weeks

,
Interventionparticipants (Number)
deathdisability of independent ambulationloss of upper arm functiontracheotomyuse of respiratoruse of tube feeding
MCI-1862282015
Placebo of MCI-1862234233

Percentage of Participants With Abnormal Changes in Sensory Examinations

(NCT00330681)
Timeframe: 24 weeks

,
Interventionpercentage of participants (Number)
NumbnessStaggeringVibratory sensation
MCI-186120
Placebo of MCI-18613.81

Percentage of Participants With Laboratory Tests for Which the Incidence of Abnormal Changes Was 5% or Higher in Either Group

(NCT00330681)
Timeframe: 24 weeks

,
Interventionpercentage of participants (Number)
White blood cell counturinary glucose
MCI-18626.9
Placebo of MCI-1865.82.9

Reviews

7 reviews available for antipyrine and ALS - Amyotrophic Lateral Sclerosis

ArticleYear
Clinical efficacy of edaravone for the treatment of amyotrophic lateral sclerosis.
    Expert opinion on pharmacotherapy, 2017, Volume: 18, Issue:7

    Topics: Amyotrophic Lateral Sclerosis; Animals; Antipyrine; Disease Models, Animal; Edaravone; Free Radical

2017
Edaravone and its clinical development for amyotrophic lateral sclerosis.
    Amyotrophic lateral sclerosis & frontotemporal degeneration, 2017, Volume: 18, Issue:sup1

    Topics: Amyotrophic Lateral Sclerosis; Antipyrine; Clinical Trials as Topic; Edaravone; Free Radical Scaveng

2017
What can we learn from the edaravone development program for ALS?
    Amyotrophic lateral sclerosis & frontotemporal degeneration, 2017, Volume: 18, Issue:sup1

    Topics: Amyotrophic Lateral Sclerosis; Antipyrine; Clinical Trials as Topic; Edaravone; Free Radical Scaveng

2017
July 2017 ENCALS statement on edaravone.
    Amyotrophic lateral sclerosis & frontotemporal degeneration, 2017, Volume: 18, Issue:7-8

    Topics: Amyotrophic Lateral Sclerosis; Antipyrine; Decision Making; Edaravone; Free Radical Scavengers; Huma

2017
Edaravone: a new hope for deadly amyotrophic lateral sclerosis.
    Drugs of today (Barcelona, Spain : 1998), 2018, Volume: 54, Issue:6

    Topics: Amyotrophic Lateral Sclerosis; Antipyrine; Edaravone; Free Radical Scavengers; Humans; Neuroprotecti

2018
Novel therapies in development that inhibit motor neuron hyperexcitability in amyotrophic lateral sclerosis.
    Expert review of neurotherapeutics, 2016, Volume: 16, Issue:10

    Topics: Amyotrophic Lateral Sclerosis; Antipyrine; Edaravone; Humans; Motor Neurons; Neuroprotective Agents;

2016
Drugs in clinical development for the treatment of amyotrophic lateral sclerosis.
    Expert opinion on investigational drugs, 2017, Volume: 26, Issue:4

    Topics: Amyotrophic Lateral Sclerosis; Animals; Antipyrine; Biological Therapy; Biomarkers; Cell- and Tissue

2017

Trials

13 trials available for antipyrine and ALS - Amyotrophic Lateral Sclerosis

ArticleYear
Edaravone efficacy in amyotrophic lateral sclerosis with reduced forced vital capacity: Post-hoc analysis of Study 19 (MCI186-19) [clinical trial NCT01492686].
    PloS one, 2022, Volume: 17, Issue:6

    Topics: Amyotrophic Lateral Sclerosis; Antipyrine; Double-Blind Method; Edaravone; Free Radical Scavengers;

2022
Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial.
    The Lancet. Neurology, 2017, Volume: 16, Issue:7

    Topics: Adult; Aged; Amyotrophic Lateral Sclerosis; Antipyrine; Double-Blind Method; Edaravone; Female; Free

2017
Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial.
    The Lancet. Neurology, 2017, Volume: 16, Issue:7

    Topics: Adult; Aged; Amyotrophic Lateral Sclerosis; Antipyrine; Double-Blind Method; Edaravone; Female; Free

2017
Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial.
    The Lancet. Neurology, 2017, Volume: 16, Issue:7

    Topics: Adult; Aged; Amyotrophic Lateral Sclerosis; Antipyrine; Double-Blind Method; Edaravone; Female; Free

2017
Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial.
    The Lancet. Neurology, 2017, Volume: 16, Issue:7

    Topics: Adult; Aged; Amyotrophic Lateral Sclerosis; Antipyrine; Double-Blind Method; Edaravone; Female; Free

2017
Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial.
    The Lancet. Neurology, 2017, Volume: 16, Issue:7

    Topics: Adult; Aged; Amyotrophic Lateral Sclerosis; Antipyrine; Double-Blind Method; Edaravone; Female; Free

2017
Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial.
    The Lancet. Neurology, 2017, Volume: 16, Issue:7

    Topics: Adult; Aged; Amyotrophic Lateral Sclerosis; Antipyrine; Double-Blind Method; Edaravone; Female; Free

2017
Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial.
    The Lancet. Neurology, 2017, Volume: 16, Issue:7

    Topics: Adult; Aged; Amyotrophic Lateral Sclerosis; Antipyrine; Double-Blind Method; Edaravone; Female; Free

2017
Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial.
    The Lancet. Neurology, 2017, Volume: 16, Issue:7

    Topics: Adult; Aged; Amyotrophic Lateral Sclerosis; Antipyrine; Double-Blind Method; Edaravone; Female; Free

2017
Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial.
    The Lancet. Neurology, 2017, Volume: 16, Issue:7

    Topics: Adult; Aged; Amyotrophic Lateral Sclerosis; Antipyrine; Double-Blind Method; Edaravone; Female; Free

2017
Post-hoc analysis of randomised, placebo-controlled, double-blind study (MCI186-19) of edaravone (MCI-186) in amyotrophic lateral sclerosis.
    Amyotrophic lateral sclerosis & frontotemporal degeneration, 2017, Volume: 18, Issue:sup1

    Topics: Aged; Amyotrophic Lateral Sclerosis; Antipyrine; Double-Blind Method; Edaravone; Female; Free Radica

2017
Post-hoc analysis of MCI186-17, the extension study to MCI186-16, the confirmatory double-blind, parallel-group, placebo-controlled study of edaravone in amyotrophic lateral sclerosis.
    Amyotrophic lateral sclerosis & frontotemporal degeneration, 2017, Volume: 18, Issue:sup1

    Topics: Adult; Aged; Amyotrophic Lateral Sclerosis; Antipyrine; Double-Blind Method; Edaravone; Female; Free

2017
Exploratory double-blind, parallel-group, placebo-controlled study of edaravone (MCI-186) in amyotrophic lateral sclerosis (Japan ALS severity classification: Grade 3, requiring assistance for eating, excretion or ambulation).
    Amyotrophic lateral sclerosis & frontotemporal degeneration, 2017, Volume: 18, Issue:sup1

    Topics: Activities of Daily Living; Adult; Aged; Amyotrophic Lateral Sclerosis; Antipyrine; Double-Blind Met

2017
Post-hoc analysis of open-label extension period of study MCI186-19 in amyotrophic lateral sclerosis.
    Amyotrophic lateral sclerosis & frontotemporal degeneration, 2017, Volume: 18, Issue:sup1

    Topics: Amyotrophic Lateral Sclerosis; Antipyrine; Double-Blind Method; Edaravone; Female; Free Radical Scav

2017
A post-hoc subgroup analysis of outcomes in the first phase III clinical study of edaravone (MCI-186) in amyotrophic lateral sclerosis.
    Amyotrophic lateral sclerosis & frontotemporal degeneration, 2017, Volume: 18, Issue:sup1

    Topics: Aged; Amyotrophic Lateral Sclerosis; Antipyrine; Double-Blind Method; Edaravone; Female; Free Radica

2017
Exploratory double-blind, parallel-group, placebo-controlled extension study of edaravone (MCI-186) in amyotrophic lateral sclerosis.
    Amyotrophic lateral sclerosis & frontotemporal degeneration, 2017, Volume: 18, Issue:sup1

    Topics: Adult; Aged; Amyotrophic Lateral Sclerosis; Antipyrine; Double-Blind Method; Edaravone; Female; Free

2017
A safety analysis of edaravone (MCI-186) during the first six cycles (24 weeks) of amyotrophic lateral sclerosis (ALS) therapy from the double-blind period in three randomized, placebo-controlled studies.
    Amyotrophic lateral sclerosis & frontotemporal degeneration, 2017, Volume: 18, Issue:sup1

    Topics: Adult; Aged; Amyotrophic Lateral Sclerosis; Antipyrine; Double-Blind Method; Edaravone; Female; Free

2017
Open-label 24-week extension study of edaravone (MCI-186) in amyotrophic lateral sclerosis.
    Amyotrophic lateral sclerosis & frontotemporal degeneration, 2017, Volume: 18, Issue:sup1

    Topics: Adult; Aged; Amyotrophic Lateral Sclerosis; Antipyrine; Double-Blind Method; Edaravone; Female; Free

2017
Confirmatory double-blind, parallel-group, placebo-controlled study of efficacy and safety of edaravone (MCI-186) in amyotrophic lateral sclerosis patients.
    Amyotrophic lateral sclerosis & frontotemporal degeneration, 2014, Volume: 15, Issue:7-8

    Topics: Adult; Aged; Amyotrophic Lateral Sclerosis; Analysis of Variance; Antipyrine; Double-Blind Method; E

2014
Confirmatory double-blind, parallel-group, placebo-controlled study of efficacy and safety of edaravone (MCI-186) in amyotrophic lateral sclerosis patients.
    Amyotrophic lateral sclerosis & frontotemporal degeneration, 2014, Volume: 15, Issue:7-8

    Topics: Adult; Aged; Amyotrophic Lateral Sclerosis; Analysis of Variance; Antipyrine; Double-Blind Method; E

2014
Confirmatory double-blind, parallel-group, placebo-controlled study of efficacy and safety of edaravone (MCI-186) in amyotrophic lateral sclerosis patients.
    Amyotrophic lateral sclerosis & frontotemporal degeneration, 2014, Volume: 15, Issue:7-8

    Topics: Adult; Aged; Amyotrophic Lateral Sclerosis; Analysis of Variance; Antipyrine; Double-Blind Method; E

2014
Confirmatory double-blind, parallel-group, placebo-controlled study of efficacy and safety of edaravone (MCI-186) in amyotrophic lateral sclerosis patients.
    Amyotrophic lateral sclerosis & frontotemporal degeneration, 2014, Volume: 15, Issue:7-8

    Topics: Adult; Aged; Amyotrophic Lateral Sclerosis; Analysis of Variance; Antipyrine; Double-Blind Method; E

2014
Confirmatory double-blind, parallel-group, placebo-controlled study of efficacy and safety of edaravone (MCI-186) in amyotrophic lateral sclerosis patients.
    Amyotrophic lateral sclerosis & frontotemporal degeneration, 2014, Volume: 15, Issue:7-8

    Topics: Adult; Aged; Amyotrophic Lateral Sclerosis; Analysis of Variance; Antipyrine; Double-Blind Method; E

2014
Confirmatory double-blind, parallel-group, placebo-controlled study of efficacy and safety of edaravone (MCI-186) in amyotrophic lateral sclerosis patients.
    Amyotrophic lateral sclerosis & frontotemporal degeneration, 2014, Volume: 15, Issue:7-8

    Topics: Adult; Aged; Amyotrophic Lateral Sclerosis; Analysis of Variance; Antipyrine; Double-Blind Method; E

2014
Confirmatory double-blind, parallel-group, placebo-controlled study of efficacy and safety of edaravone (MCI-186) in amyotrophic lateral sclerosis patients.
    Amyotrophic lateral sclerosis & frontotemporal degeneration, 2014, Volume: 15, Issue:7-8

    Topics: Adult; Aged; Amyotrophic Lateral Sclerosis; Analysis of Variance; Antipyrine; Double-Blind Method; E

2014
Confirmatory double-blind, parallel-group, placebo-controlled study of efficacy and safety of edaravone (MCI-186) in amyotrophic lateral sclerosis patients.
    Amyotrophic lateral sclerosis & frontotemporal degeneration, 2014, Volume: 15, Issue:7-8

    Topics: Adult; Aged; Amyotrophic Lateral Sclerosis; Analysis of Variance; Antipyrine; Double-Blind Method; E

2014
Confirmatory double-blind, parallel-group, placebo-controlled study of efficacy and safety of edaravone (MCI-186) in amyotrophic lateral sclerosis patients.
    Amyotrophic lateral sclerosis & frontotemporal degeneration, 2014, Volume: 15, Issue:7-8

    Topics: Adult; Aged; Amyotrophic Lateral Sclerosis; Analysis of Variance; Antipyrine; Double-Blind Method; E

2014
Increased oxidative stress in patients with amyotrophic lateral sclerosis and the effect of edaravone administration.
    Redox report : communications in free radical research, 2016, Volume: 21, Issue:3

    Topics: Aged; Amyotrophic Lateral Sclerosis; Antipyrine; Biomarkers; Edaravone; Fatty Acids, Nonesterified;

2016
Investigation of the therapeutic effects of edaravone, a free radical scavenger, on amyotrophic lateral sclerosis (Phase II study).
    Amyotrophic lateral sclerosis : official publication of the World Federation of Neurology Research Group on Motor Neuron Diseases, 2006, Volume: 7, Issue:4

    Topics: Amyotrophic Lateral Sclerosis; Antipyrine; Dose-Response Relationship, Drug; Edaravone; Female; Free

2006

Other Studies

18 other studies available for antipyrine and ALS - Amyotrophic Lateral Sclerosis

ArticleYear
Efficacy and Safety of Edaravone in Amyotrophic Lateral Sclerosis Patients in Indian Population.
    The Journal of the Association of Physicians of India, 2022, Volume: 70, Issue:4

    Topics: Amyotrophic Lateral Sclerosis; Animals; Antipyrine; Double-Blind Method; Edaravone; Humans; Neurodeg

2022
Long-term outcomes of edaravone in amyotrophic lateral sclerosis in South Korea: 72-week observational study.
    BMC neurology, 2022, Jul-14, Volume: 22, Issue:1

    Topics: Amyotrophic Lateral Sclerosis; Antipyrine; Double-Blind Method; Edaravone; Humans; Neurodegenerative

2022
In brief: Edaravone oral suspension (Radicava ORS) for ALS.
    The Medical letter on drugs and therapeutics, 2022, 09-05, Volume: 64, Issue:1658

    Topics: Amyotrophic Lateral Sclerosis; Antipyrine; Edaravone; Electrolytes; Free Radical Scavengers; Humans;

2022
Improvement of a decreased anti-oxidative activity by edaravone in amyotrophic lateral sclerosis patients.
    Journal of the neurological sciences, 2020, Aug-15, Volume: 415

    Topics: Amyotrophic Lateral Sclerosis; Antipyrine; Edaravone; Free Radical Scavengers; Humans; Oxidation-Red

2020
Edaravone: a new treatment for ALS on the horizon?
    The Lancet. Neurology, 2017, Volume: 16, Issue:7

    Topics: Amyotrophic Lateral Sclerosis; Antipyrine; Edaravone; Free Radical Scavengers; Humans

2017
Edaravone for treatment of early-stage ALS - Authors' reply.
    The Lancet. Neurology, 2017, Volume: 16, Issue:10

    Topics: Amyotrophic Lateral Sclerosis; Antipyrine; Edaravone; Free Radical Scavengers; Humans

2017
Edaravone for treatment of early-stage ALS.
    The Lancet. Neurology, 2017, Volume: 16, Issue:10

    Topics: Amyotrophic Lateral Sclerosis; Antipyrine; Edaravone; Free Radical Scavengers; Humans

2017
Amyotrophic Lateral Sclerosis: Precise Diagnosis and Individualized Treatment.
    Chinese medical journal, 2017, 10-05, Volume: 130, Issue:19

    Topics: Adaptor Proteins, Signal Transducing; Amyotrophic Lateral Sclerosis; Antipyrine; Autophagy-Related P

2017
Drug therapy: On the treatment trail for ALS.
    Nature, 2017, 10-18, Volume: 550, Issue:7676

    Topics: Amyotrophic Lateral Sclerosis; Antipyrine; Benzamides; C9orf72 Protein; Clinical Trials as Topic; Di

2017
Edaravone: A new drug approved for ALS.
    Cell, 2017, Nov-02, Volume: 171, Issue:4

    Topics: Amyotrophic Lateral Sclerosis; Antipyrine; Drug Approval; Edaravone; Excitatory Amino Acid Antagonis

2017
Edaravone (Radicava) for ALS.
    The Medical letter on drugs and therapeutics, 2017, 11-06, Volume: 59, Issue:1533

    Topics: Amyotrophic Lateral Sclerosis; Antipyrine; Edaravone; Free Radical Scavengers; Humans; Oxidative Str

2017
Discussing edaravone with the ALS patient: an ethical framework from a U.S. perspective.
    Amyotrophic lateral sclerosis & frontotemporal degeneration, 2018, Volume: 19, Issue:3-4

    Topics: Amyotrophic Lateral Sclerosis; Antipyrine; Clinical Trials as Topic; Cost-Benefit Analysis; Edaravon

2018
Edaravone administration in pivotal clinical Study 19.
    Amyotrophic lateral sclerosis & frontotemporal degeneration, 2019, Volume: 20, Issue:3-4

    Topics: Amyotrophic Lateral Sclerosis; Antipyrine; Edaravone; Free Radical Scavengers; Humans

2019
Edaravone, a Free Radical Scavenger, Delayed Symptomatic and Pathological Progression of Motor Neuron Disease in the Wobbler Mouse.
    PloS one, 2015, Volume: 10, Issue:10

    Topics: Amyotrophic Lateral Sclerosis; Animals; Antipyrine; Astrocytes; Disease Models, Animal; Disease Prog

2015
Treatment with edaravone, initiated at symptom onset, slows motor decline and decreases SOD1 deposition in ALS mice.
    Experimental neurology, 2008, Volume: 213, Issue:2

    Topics: Amyotrophic Lateral Sclerosis; Animals; Antipyrine; Edaravone; Female; Humans; Male; Mice; Mice, Tra

2008
Edaravone in ALS.
    Experimental neurology, 2009, Volume: 217, Issue:2

    Topics: Amyotrophic Lateral Sclerosis; Animals; Antipyrine; Clinical Trials as Topic; Disease Models, Animal

2009
Feasibility study for functional test battery of SOD transgenic rat (H46R) and evaluation of edaravone, a free radical scavenger.
    Brain research, 2011, Mar-25, Volume: 1382

    Topics: Amyotrophic Lateral Sclerosis; Animals; Antipyrine; Disease Models, Animal; Edaravone; Feasibility S

2011
Voltage-dependent sodium channels in spinal cord motor neurons display rapid recovery from fast inactivation in a mouse model of amyotrophic lateral sclerosis.
    Journal of neurophysiology, 2006, Volume: 96, Issue:6

    Topics: Algorithms; Amino Acid Substitution; Amyotrophic Lateral Sclerosis; Animals; Antipyrine; Cells, Cult

2006