Safety and Tolerability of Dalfampridine in Subjects With Cerebral Palsy
This study has been completed.
Sponsor:
Acorda Therapeutics
ClinicalTrials.gov Identifier:
NCT01468350
First Posted: November 9, 2011
Last Update Posted: June 24, 2014
Information provided by (Responsible Party):
Acorda Therapeutics
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
| Cerebral Palsy (CP) | Drug: dalfampridine-ER 10mg Other: Placebo | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Acorda Therapeutics:
Primary Outcome Measures:
- Safety and Tolerability of Dalfampridine-ER 10mg in Subjects With Cerebral Palsy (CP) [ Time Frame: up to 31 days ]
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
Secondary Outcome Measures:
- Measure the Effects of Both Single and Multiple Doses of Dalfampridine-ER 10 mg on Sensorimotor Function [ Time Frame: up to 31 days ]
- 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)
| Enrollment: | 35 |
| Study Start Date: | December 2011 |
| Study Completion Date: | March 2013 |
| Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: (PART A) AB: dalfampridine-ER 10mg then placebo
Each 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
|
Drug: dalfampridine-ER 10mg Other: Placebo |
|
Placebo Comparator: (PART A) BA: placebo then dalfampridine-ER 10mg
Each 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
|
Drug: dalfampridine-ER 10mg Other: Placebo |
|
Placebo Comparator: (PART B) AB: dalfampridine-ER 10mg then placebo
Each subject randomized to the AB arm will receive multiple doses of (A) dalfampridine-ER 10mg and multiple doses of (B) placebo
|
Drug: dalfampridine-ER 10mg Other: Placebo |
|
Placebo Comparator: (PART B) BA: Placebo then dalfampridine-ER 10mg
Each subject randomized to the BA arm will receive multiple doses of (B) placebo, and multiple doses of (A) dalfampridine-ER 10mg
|
Drug: dalfampridine-ER 10mg Other: Placebo |
Eligibility
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01468350
Locations
| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| Rancho Los Amigos National Rehabilitation Center | |
| Downey, California, United States, 90242 | |
| UCLA/Orthopaedic Hospital Center for Cerebral Palsy | |
| Los Angeles, California, United States, 90095 | |
| Rady Children's Hospital San Diego | |
| San Diego, California, United States, 92123 | |
| United States, Illinois | |
| Rehabilitation Institute of Chicago | |
| Chicago, Illinois, United States, 60611 | |
| United States, Maryland | |
| Kennedy Krieger Institute at Johns Hopkins University | |
| Baltimore, Maryland, United States, 21205 | |
| United States, Michigan | |
| Detroit Clinical Research Center | |
| Farmington Hills, Michigan, United States, 48334 | |
| United States, Minnesota | |
| Gillette Children's Specialty Healthcare | |
| St. Paul, Minnesota, United States, 55101 | |
| United States, Missouri | |
| University of Missouri at Columbia | |
| Columbia, Missouri, United States, 65212 | |
| United States, Ohio | |
| Cleveland Clinic | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Washington | |
| Swedish Medical Center | |
| Seattle, Washington, United States, 98122 | |
Sponsors and Collaborators
Acorda Therapeutics
Investigators
| Study Director: | Enrique Carrazana, MD | Acorda Therapeutics |
More Information
| Responsible Party: | Acorda Therapeutics |
| ClinicalTrials.gov Identifier: | NCT01468350 History of Changes |
| Other Study ID Numbers: |
DALF-CP-1002 |
| First Submitted: | November 7, 2011 |
| First Posted: | November 9, 2011 |
| Results First Submitted: | March 24, 2014 |
| Results First Posted: | June 24, 2014 |
| Last Update Posted: | June 24, 2014 |
| Last Verified: | May 2014 |
Additional relevant MeSH terms:
|
Paralysis Cerebral Palsy Neurologic Manifestations Nervous System Diseases Signs and Symptoms Brain Damage, Chronic |
Brain Diseases Central Nervous System Diseases 4-Aminopyridine Potassium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |