Safety and Tolerability of Dalfampridine in Subjects With Cerebral Palsy
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
1 other identifier
interventional
35
1 country
11
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2011
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2011
CompletedFirst Posted
Study publicly available on registry
November 9, 2011
CompletedStudy Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedResults Posted
Study results publicly available
June 24, 2014
CompletedJune 24, 2014
May 1, 2014
1.1 years
November 7, 2011
March 24, 2014
May 22, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Measure the Effects of Both Single and Multiple Doses of Dalfampridine-ER 10 mg on Sensorimotor Function
up to 31 days
Study Arms (4)
(PART A) AB: dalfampridine-ER 10mg then placebo
PLACEBO COMPARATOREach 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
PLACEBO COMPARATOREach 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
PLACEBO COMPARATOREach 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
PLACEBO COMPARATOREach subject randomized to the BA arm will receive multiple doses of (B) placebo, and multiple doses of (A) dalfampridine-ER 10mg
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Rancho Los Amigos National Rehabilitation Center
Downey, California, 90242, United States
UCLA/Orthopaedic Hospital Center for Cerebral Palsy
Los Angeles, California, 90095, United States
Rady Children's Hospital San Diego
San Diego, California, 92123, United States
Rehabilitation Institute of Chicago
Chicago, Illinois, 60611, United States
Kennedy Krieger Institute at Johns Hopkins University
Baltimore, Maryland, 21205, United States
Detroit Clinical Research Center
Farmington Hills, Michigan, 48334, United States
Gillette Children's Specialty Healthcare
Saint Paul, Minnesota, 55101, United States
University of Missouri at Columbia
Columbia, Missouri, 65212, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
Related Publications (1)
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.
PMID: 28131322DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President - Clinical Development & Medical Affairs
- Organization
- Acorda Therapeutics, Inc.
Study Officials
- STUDY DIRECTOR
Enrique Carrazana, MD
Acorda Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2011
First Posted
November 9, 2011
Study Start
December 1, 2011
Primary Completion
January 1, 2013
Study Completion
March 1, 2013
Last Updated
June 24, 2014
Results First Posted
June 24, 2014
Record last verified: 2014-05