Phase 1
Completed N=11
Safety and Tolerability of Dalfampridine in Subjects With Cerebral Palsy
Cerebral Palsy (CP)
Source: ClinicalTrials.gov NCT01468350 ↗
Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcomePrimary: Safety and Tolerability of Dalfampridine-ER 10mg in Subjects With Cerebral Palsy (CP) — 1; 2; 6; 9 participants
Summary
A double-blind, placebo-controlled, crossover study in subjects with cerebral palsy (CP) to evaluate the safety and tolerability and the effect of dalfampridine extended release (ER) tablets on sensorimotor function
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability of Dalfampridine-ER 10mg in Subjects With Cerebral Palsy (CP) |
1; 2; 6; 9; 0; 0 | — |
| SECONDARY Measure the Effects of Both Single and Multiple Doses of Dalfampridine-ER 10 mg on Sensorimotor Function |
— | — |
Eligibility Criteria
Inclusion Criteria
- A diagnosis of CP
- No previous use of any dalfampridine formulation
- Ability to perform all the required study procedures. Subjects should be capable of fully extending and flexing both hands
Exclusion Criteria
- Presence of any progressive neurological disease
- Severe CP defined as the requirement to use a wheelchair at all times and a care taker for constant assistance in daily activities. This definition includes spastic quadriplegia
- Pregnant or breastfeeding
Data sourced from ClinicalTrials.gov (NCT01468350). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.