Clinical trial NCT01468350: Safety and Tolerability of Dalfampridine in Subjects With Cerebral Palsy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cerebral Palsy (CP)
Lead sponsor: Acorda Therapeutics
Sponsor class: INDUSTRY
First posted: 2011-11-09
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Safety and Tolerability of Dalfampridine-ER 10mg in Subjects With Cerebral Palsy (CP)
timeFrame: up to 31 days
Secondary outcomes:
measure: Measure the Effects of Both Single and Multiple Doses of Dalfampridine-ER 10 mg on Sensorimotor Function
timeFrame: up to 31 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Downey
country: United States
facility: Rancho Los Amigos National Rehabilitation Center
state: California
city: Los Angeles
country: United States
facility: UCLA/Orthopaedic Hospital Center for Cerebral Palsy
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital San Diego
state: California
city: Chicago
country: United States
facility: Rehabilitation Institute of Chicago
state: Illinois
city: Baltimore
country: United States
facility: Kennedy Krieger Institute at Johns Hopkins University
state: Maryland
city: Farmington Hills
country: United States
facility: Detroit Clinical Research Center
state: Michigan
city: St. Paul
country: United States
facility: Gillette Children's Specialty Healthcare
state: Minnesota
city: Columbia
country: United States
facility: University of Missouri at Columbia
state: Missouri
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
Study officials:
affiliation: Acorda Therapeutics
name: Enrique Carrazana, MD
role: STUDY_DIRECTOR
References:
citation: Bethoux F, Fatemi A, Fowler E, Marciniak C, Mayadev A, Waksman J, Zackowski K, Suarez G, Blight AR, Rabinowicz AL, Carrazana E. Safety, Tolerability, and Sensorimotor Effects of Extended-release Dalfampridine in Adults With Cerebral Palsy: A Pilot Study. Clin Ther. 2017 Feb;39(2):337-346. doi: 10.1016/j.clinthera.2016.12.015. Epub 2017 Jan 25.