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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01468350
Other study ID # DALF-CP-1002
Secondary ID
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


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
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