Status:
COMPLETED
Safety and Tolerability of Dalfampridine in Subjects With Cerebral Palsy
Lead Sponsor:
Acorda Therapeutics
Conditions:
Cerebral Palsy (CP)
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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 sensor...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01468350
Start Date
December 1 2011
End Date
March 1 2013
Last Update
June 24 2014
Active Locations (11)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Rancho Los Amigos National Rehabilitation Center
Downey, California, United States, 90242
3
UCLA/Orthopaedic Hospital Center for Cerebral Palsy
Los Angeles, California, United States, 90095
4
Rady Children's Hospital San Diego
San Diego, California, United States, 92123