4-aminopyridine has been researched along with Cerebral Palsy, Athetoid in 1 studies
Excerpt | Relevance | Reference |
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" Adverse events were consistent with previous D-ER trials, most commonly headache (13% D-ER, 4% placebo), fatigue (13% D-ER, 0% placebo), insomnia (8% D-ER, 4% placebo), diarrhea (4% D-ER, 4% placebo), and nausea (4% D-ER, 4% placebo)." | 2.84 | Safety, Tolerability, and Sensorimotor Effects of Extended-release Dalfampridine in Adults With Cerebral Palsy: A Pilot Study. ( Bethoux, F; Blight, AR; Carrazana, E; Fatemi, A; Fowler, E; Marciniak, C; Mayadev, A; Rabinowicz, AL; Suarez, G; Waksman, J; Zackowski, K, 2017) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 0 (0.00) | 18.7374 |
1990's | 0 (0.00) | 18.2507 |
2000's | 0 (0.00) | 29.6817 |
2010's | 1 (100.00) | 24.3611 |
2020's | 0 (0.00) | 2.80 |
Authors | Studies |
---|---|
Bethoux, F | 1 |
Fatemi, A | 1 |
Fowler, E | 1 |
Marciniak, C | 1 |
Mayadev, A | 1 |
Waksman, J | 1 |
Zackowski, K | 1 |
Suarez, G | 1 |
Blight, AR | 1 |
Rabinowicz, AL | 1 |
Carrazana, E | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
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A Double-Blind, Placebo-Controlled, Crossover Study in Subjects With Cerebral Palsy to Evaluate the Safety and Tolerability and the Effect on Sensorimotor Function of Dalfampridine-ER[NCT01468350] | Phase 1 | 35 participants (Actual) | Interventional | 2011-12-31 | Completed | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
"Safety and tolerability will be assessed primarily by monitoring Treatment Emergent Adverse Events (TEAEs)~TEAEs are defined as Adverse Events (AEs) with date of onset (or worsening) on or after the start-date of double-blind treatment and no more than 5 days after the last dose of double-blind treatment for Part A of the study and no more than 9 days for Part B of the study.~The severity categories of mild, moderate or severe, are defined below:~Mild is defined as causing no limitation of usual activities~Moderate is defined as causing some limitation of usual activities~Severe is defined as causing inability to carry out usual activities" (NCT01468350)
Timeframe: up to 31 days
Intervention | participants (Number) | ||||||
---|---|---|---|---|---|---|---|
TEAEs | Serious TEAEs | TEAEs Maximum Severity - Mild | TEAEs Maximum Severity - Moderate | TEAEs Maximum Severity - Severe | TEAEs Possibly Related to Study Drug | TEAEs Leading to Withdrawal of Study Drug | |
PART A: Dalfampridine-ER 10mg | 2 | 0 | 2 | 0 | 0 | 0 | 0 |
PART A: Placebo | 1 | 0 | 1 | 0 | 0 | 1 | 0 |
PART B: Dalfampridine-ER 10mg | 9 | 0 | 8 | 1 | 0 | 7 | 0 |
PART B: Placebo | 6 | 0 | 5 | 1 | 0 | 3 | 0 |
1 trial available for 4-aminopyridine and Cerebral Palsy, Athetoid
Article | Year |
---|---|
Safety, Tolerability, and Sensorimotor Effects of Extended-release Dalfampridine in Adults With Cerebral Palsy: A Pilot Study.
Topics: 4-Aminopyridine; Adult; Cerebral Palsy; Cross-Over Studies; Delayed-Action Preparations; Double-Blin | 2017 |