Page last updated: 2024-10-21
4-aminopyridine and Cerebral Palsy
4-aminopyridine has been researched along with Cerebral Palsy in 1 studies
Cerebral Palsy: A heterogeneous group of nonprogressive motor disorders caused by chronic brain injuries that originate in the prenatal period, perinatal period, or first few years of life. The four major subtypes are spastic, athetoid, ataxic, and mixed cerebral palsy, with spastic forms being the most common. The motor disorder may range from difficulties with fine motor control to severe spasticity (see MUSCLE SPASTICITY) in all limbs. Spastic diplegia (Little disease) is the most common subtype, and is characterized by spasticity that is more prominent in the legs than in the arms. Pathologically, this condition may be associated with LEUKOMALACIA, PERIVENTRICULAR. (From Dev Med Child Neurol 1998 Aug;40(8):520-7)
Research Excerpts
| Excerpt | Relevance | Reference |
|---|
| " 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) |
Research
Studies (1)
| 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
| 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 |
Clinical Trials (1)
Trial Overview
| Trial | Phase | Enrollment | Study Type | Start Date | Status |
|---|
| 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] |
Trial Outcomes
Safety and Tolerability of Dalfampridine-ER 10mg in Subjects With Cerebral Palsy (CP)
"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 |
Trials
1 trial available for 4-aminopyridine and Cerebral Palsy