Safety and Tolerability of Dalfampridine in Subjects With Cerebral Palsy

Acorda Therapeutics35 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Cerebral Palsy (CP)

Interventions

dalfampridine-ER 10mgDRUG

PlaceboOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (11)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Rancho Los Amigos National Rehabilitation Center

Downey, California, United States

UCLA/Orthopaedic Hospital Center for Cerebral Palsy

Los Angeles, California, United States

Outcomes

Primary 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

Time frame: up to 31 days

Secondary Outcomes

Measure the Effects of Both Single and Multiple Doses of Dalfampridine-ER 10 mg on Sensorimotor Function

* Hand strength as measured by a composite Z-score derived from the grip test, and key, tip and palmar pinch tests * Manual dexterity as measured by the Box and Block Test * Walking speed as measured by the Timed 25 Foot Walk (T25FW) * Gait as measured by gait analysis equipment (to be performed by sites that have the capability to perform it) * For Part B only, subjective impressions of treatment as measured by: * Subject Global Impression (SGI) * Clinician Global Impression (CGI)

Time frame: up to 31 days

Data from ClinicalTrials.gov

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