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
Overview
- Phase
- Phase 1
- Intervention
- dalfampridine-ER 10mg
- Conditions
- Cerebral Palsy (CP)
- Sponsor
- Acorda Therapeutics
- Enrollment
- 35
- Locations
- 11
- Primary Endpoint
- Safety and Tolerability of Dalfampridine-ER 10mg in Subjects With Cerebral Palsy (CP)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief 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
Investigators
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
Arms & Interventions
(PART A) AB: dalfampridine-ER 10mg then placebo
Each subject randomized to the AB arm will receive a single witnessed dose of (A) dalfampridine-ER 10 mg, and a single witnessed dose of (B) placebo, two days apart
Intervention: dalfampridine-ER 10mg
(PART A) AB: dalfampridine-ER 10mg then placebo
Each subject randomized to the AB arm will receive a single witnessed dose of (A) dalfampridine-ER 10 mg, and a single witnessed dose of (B) placebo, two days apart
Intervention: Placebo
(PART A) BA: placebo then dalfampridine-ER 10mg
Each subject randomized to the BA arm will receive a single witnessed dose of (B) placebo, and a single witnessed dose of (A) dalfampridine-ER 10 mg, two days apart
Intervention: dalfampridine-ER 10mg
(PART A) BA: placebo then dalfampridine-ER 10mg
Each subject randomized to the BA arm will receive a single witnessed dose of (B) placebo, and a single witnessed dose of (A) dalfampridine-ER 10 mg, two days apart
Intervention: Placebo
(PART B) AB: dalfampridine-ER 10mg then placebo
Each subject randomized to the AB arm will receive multiple doses of (A) dalfampridine-ER 10mg and multiple doses of (B) placebo
Intervention: dalfampridine-ER 10mg
(PART B) AB: dalfampridine-ER 10mg then placebo
Each subject randomized to the AB arm will receive multiple doses of (A) dalfampridine-ER 10mg and multiple doses of (B) placebo
Intervention: Placebo
(PART B) BA: Placebo then dalfampridine-ER 10mg
Each subject randomized to the BA arm will receive multiple doses of (B) placebo, and multiple doses of (A) dalfampridine-ER 10mg
Intervention: dalfampridine-ER 10mg
(PART B) BA: Placebo then dalfampridine-ER 10mg
Each subject randomized to the BA arm will receive multiple doses of (B) placebo, and multiple doses of (A) dalfampridine-ER 10mg
Intervention: Placebo
Outcomes
Primary Outcomes
Safety and Tolerability of Dalfampridine-ER 10mg in Subjects With Cerebral Palsy (CP)
Time Frame: up to 31 days
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
Secondary Outcomes
- Measure the Effects of Both Single and Multiple Doses of Dalfampridine-ER 10 mg on Sensorimotor Function(up to 31 days)