riluzole has been researched along with Adverse Drug Event in 7 studies
Riluzole: A glutamate antagonist (RECEPTORS, GLUTAMATE) used as an anticonvulsant (ANTICONVULSANTS) and to prolong the survival of patients with AMYOTROPHIC LATERAL SCLEROSIS.
| Excerpt | Relevance | Reference |
|---|---|---|
| "In a pilot study, lithium treatment slowed progression of amyotrophic lateral sclerosis (ALS)." | 9.14 | Safety and efficacy of lithium in combination with riluzole for treatment of amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. ( Aggarwal, SP; Conwit, RA; Cudkowicz, M; Jackson, KE; Kaufman, P; McKinley, J; Pinto, H; Schoenfeld, D; Shefner, J; Simpson, E; Zinman, L, 2010) |
| "Riluzole is the only treatment known to improve survival in patients with Amyotrophic Lateral Sclerosis (ALS)." | 8.31 | Spinal cord and brain concentrations of riluzole after oral and intrathecal administration: A potential new treatment route for amyotrophic lateral sclerosis. ( Bartus, R; Betourne, A; Boulis, NM; Butt, MT; Cramer, SD; Deaver, D; Gutierrez, J; Keifer, OP; Tansey, M, 2023) |
| "In a pilot study, lithium treatment slowed progression of amyotrophic lateral sclerosis (ALS)." | 5.14 | Safety and efficacy of lithium in combination with riluzole for treatment of amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. ( Aggarwal, SP; Conwit, RA; Cudkowicz, M; Jackson, KE; Kaufman, P; McKinley, J; Pinto, H; Schoenfeld, D; Shefner, J; Simpson, E; Zinman, L, 2010) |
| "Riluzole is the only treatment known to improve survival in patients with Amyotrophic Lateral Sclerosis (ALS)." | 4.31 | Spinal cord and brain concentrations of riluzole after oral and intrathecal administration: A potential new treatment route for amyotrophic lateral sclerosis. ( Bartus, R; Betourne, A; Boulis, NM; Butt, MT; Cramer, SD; Deaver, D; Gutierrez, J; Keifer, OP; Tansey, M, 2023) |
| "Riluzole is currently the only approved medication for amyotrophic lateral sclerosis (ALS)." | 3.75 | A placebo arm is not always necessary in clinical trials of amyotrophic lateral sclerosis. ( Gordon, PH, 2009) |
| "5 million adverse drug reaction (ADR) reports for 8620 drugs/biologics that are listed for 1191 Coding Symbols for Thesaurus of Adverse Reaction (COSTAR) terms of adverse effects." | 1.32 | Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling. ( Benz, RD; Contrera, JF; Kruhlak, NL; Matthews, EJ; Weaver, JL, 2004) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 3 (42.86) | 29.6817 |
| 2010's | 3 (42.86) | 24.3611 |
| 2020's | 1 (14.29) | 2.80 |
| Authors | Studies |
|---|---|
| Matthews, EJ | 1 |
| Kruhlak, NL | 1 |
| Weaver, JL | 1 |
| Benz, RD | 1 |
| Contrera, JF | 1 |
| Liu, Z | 1 |
| Shi, Q | 1 |
| Ding, D | 1 |
| Kelly, R | 1 |
| Fang, H | 1 |
| Tong, W | 1 |
| Morgan, RE | 1 |
| van Staden, CJ | 1 |
| Chen, Y | 1 |
| Kalyanaraman, N | 1 |
| Kalanzi, J | 1 |
| Dunn, RT | 1 |
| Afshari, CA | 1 |
| Hamadeh, HK | 1 |
| Keifer, OP | 1 |
| Gutierrez, J | 1 |
| Butt, MT | 1 |
| Cramer, SD | 1 |
| Bartus, R | 1 |
| Tansey, M | 1 |
| Deaver, D | 1 |
| Betourne, A | 1 |
| Boulis, NM | 1 |
| Gordon, PH | 1 |
| Simmons, Z | 1 |
| Aggarwal, SP | 1 |
| Zinman, L | 1 |
| Simpson, E | 1 |
| McKinley, J | 1 |
| Jackson, KE | 1 |
| Pinto, H | 1 |
| Kaufman, P | 1 |
| Conwit, RA | 1 |
| Schoenfeld, D | 1 |
| Shefner, J | 1 |
| Cudkowicz, M | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| A Multicenter, Double-Blind, Placebo-Controlled, Study to Investigate the Safety and Efficacy of Lithium in Combination With Riluzole in Volunteers With Amyotrophic Lateral Sclerosis (ALS)[NCT00818389] | Phase 2/Phase 3 | 84 participants (Actual) | Interventional | 2009-01-31 | Terminated (stopped due to NINDS DSMB recommended trial be terminated for futility after reviewing an interim analysis of 84 subjects.) | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
ALSFRS-R is a self-administered ordinal rating scale questionnaire (rating 0-4 for each question,4 is most functional,0-48 total)of 12 functional activities. The most functional total score is 48. ALSFRS-R done at baseline and weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 & 52, dependent on enrollment duration. Number of subjects who failed by treatment group was evaluated. Failure was defined as 6-point drop in ALSFRS-R or death from baseline. (NCT00818389)
Timeframe: 9 months: Baseline to study termination (January 2009 - October 2009)
| Intervention | Participants (Number) |
|---|---|
| Lithium + Riluzole | 18 |
| Placebo + Riluzole | 14 |
ALSFRS-R is a self-administered ordinal rating scale questionnaire (rating 0-4 for each question,4 is most functional,0-48 total)of 12 functional activities. The most functional total score is 48. ALSFRS-R done at baseline and weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 & 52, dependent on enrollment duration. Secondary efficacy was evaluated by comparing the mean rate of decline of ALSFRS-R score by treatment group. (NCT00818389)
Timeframe: 9 months: Baseline to study termination (January 2009 - October 2009)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Lithium + Riluzole | -1.24 |
| Placebo + Riluzole | -1.09 |
Secondary efficacy was measured by comparing the rate of decline of mean VC by treatment group. (NCT00818389)
Timeframe: 9 months: Baseline to study termination (January 2009- October 2009)
| Intervention | Percent of predicted normal (Mean) |
|---|---|
| Lithium + Riluzole | -1.89 |
| Placebo + Riluzole | -3.12 |
1 trial available for riluzole and Adverse Drug Event
| Article | Year |
|---|---|
Safety and efficacy of lithium in combination with riluzole for treatment of amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial.
Topics: Adult; Aged; Amyotrophic Lateral Sclerosis; Disease Progression; Double-Blind Method; Drug Therapy, | 2010 |
6 other studies available for riluzole and Adverse Drug Event
| Article | Year |
|---|---|
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
Topics: Adverse Drug Reaction Reporting Systems; Artificial Intelligence; Computers; Databases, Factual; Dru | 2004 |
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
Topics: Animals; Anti-Infective Agents; Anti-Inflammatory Agents; Chemical and Drug Induced Liver Injury; Da | 2011 |
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
Topics: Animals; ATP Binding Cassette Transporter, Subfamily B; ATP Binding Cassette Transporter, Subfamily | 2013 |
Spinal cord and brain concentrations of riluzole after oral and intrathecal administration: A potential new treatment route for amyotrophic lateral sclerosis.
Topics: Administration, Oral; Amyotrophic Lateral Sclerosis; Animals; Brain; Dogs; Drug-Related Side Effects | 2023 |
A placebo arm is not always necessary in clinical trials of amyotrophic lateral sclerosis.
Topics: Amyotrophic Lateral Sclerosis; Clinical Trials, Phase I as Topic; Controlled Clinical Trials as Topi | 2009 |
Can we eliminate placebo in ALS clinical Trials?
Topics: Amyotrophic Lateral Sclerosis; Clinical Trials, Phase II as Topic; Controlled Clinical Trials as Top | 2009 |