Safety and Tolerability of Dalfampridine in Subjects With Cerebral Palsy

Phase 1

Completed

• Conditions: Cerebral Palsy (CP)
• Interventions: Drug: dalfampridine-ER 10mg; Other: Placebo

• Registration Number: NCT01468350
• Lead Sponsor: Acorda Therapeutics

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-07
• Study First Submitted QC: 2011-11-08
• Study First Posted: 2011-11-09
• Study Start: 2011-12
• Primary Completion: 2013-01
• Study Completion: 2013-03
• Results First Submitted: 2014-03-24
• Status Verified: 2014-05
• Results First Submitted QC: 2014-05-22
• Last Update Submitted: 2014-05-22
• Results First Posted: 2014-06-24
• Last Update Posted: 2014-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
(PART A) AB: dalfampridine-ER 10mg then placebo	dalfampridine-ER 10mg	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
(PART A) AB: dalfampridine-ER 10mg then placebo	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
(PART A) BA: placebo then dalfampridine-ER 10mg	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
(PART A) BA: placebo then dalfampridine-ER 10mg	Placebo	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
(PART B) AB: dalfampridine-ER 10mg then placebo	dalfampridine-ER 10mg	Each subject randomized to the AB arm will receive multiple doses of (A) dalfampridine-ER 10mg and multiple doses of (B) placebo
(PART B) AB: dalfampridine-ER 10mg then placebo	Placebo	Each subject randomized to the AB arm will receive multiple doses of (A) dalfampridine-ER 10mg and multiple doses of (B) placebo
(PART B) BA: Placebo then dalfampridine-ER 10mg	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
(PART B) BA: Placebo then dalfampridine-ER 10mg	Placebo	Each subject randomized to the BA arm will receive multiple doses of (B) placebo, and multiple doses of (A) dalfampridine-ER 10mg

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability of Dalfampridine-ER 10mg in Subjects With Cerebral Palsy (CP)	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 Outcome Measures

Name	Time	Method
Measure the Effects of Both Single and Multiple Doses of Dalfampridine-ER 10 mg on Sensorimotor Function	up to 31 days	* 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)

Trial Locations

Locations (11)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Rehabilitation Institute of Chicago; 🇺🇸 Chicago, Illinois, United States

Detroit Clinical Research Center; 🇺🇸 Farmington Hills, Michigan, United States

University of Missouri at Columbia; 🇺🇸 Columbia, Missouri, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Rancho Los Amigos National Rehabilitation Center; 🇺🇸 Downey, California, United States

Rady Children's Hospital San Diego; 🇺🇸 San Diego, California, United States

Kennedy Krieger Institute at Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

UCLA/Orthopaedic Hospital Center for Cerebral Palsy; 🇺🇸 Los Angeles, California, United States

Gillette Children's Specialty Healthcare; 🇺🇸 St. Paul, Minnesota, United States

Swedish Medical Center; 🇺🇸 Seattle, Washington, United States