Safety and Tolerability of Dalfampridine in Subjects With Cerebral Palsy

Cerebral Palsy (CP) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01468350
• Other study ID #: DALF-CP-1002
• Status: Completed
• Phase: Phase 1
• First received: November 7, 2011
• Last updated: May 22, 2014
• Start date: December 2011
• Est. completion date: March 2013

Study information

• Verified date: May 2014
• Source: Acorda Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy (CP)

Intervention

Drug:
• dalfampridine-ER 10mg

Other:
• Placebo

Locations

Country	Name	City	State
United States	Kennedy Krieger Institute at Johns Hopkins University	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Rehabilitation Institute of Chicago	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	University of Missouri at Columbia	Columbia	Missouri
United States	Rancho Los Amigos National Rehabilitation Center	Downey	California
United States	Detroit Clinical Research Center	Farmington Hills	Michigan
United States	UCLA/Orthopaedic Hospital Center for Cerebral Palsy	Los Angeles	California
United States	Rady Children's Hospital San Diego	San Diego	California
United States	Swedish Medical Center	Seattle	Washington
United States	Gillette Children's Specialty Healthcare	St. Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Acorda Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to 31 days	Yes
Secondary	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)	up to 31 days	No