Trial record 5 of 8 for:
cerebral palsy | United States, Washington
Safety and Tolerability of Dalfampridine in Subjects With Cerebral Palsy
This study has been completed.
Sponsor:
Acorda Therapeutics
Information provided by (Responsible Party):
Acorda Therapeutics
ClinicalTrials.gov Identifier:
NCT01468350
First received: November 7, 2011
Last updated: April 3, 2013
Last verified: April 2013
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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: (PART A) dalfampridine-ER 10mg Drug: (PART B) dalfampridine-ER 10mg |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, 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 CP [ Time Frame: up to 31 days ] [ Designated as safety issue: No ]Safety and tolerability will be assessed primarily by monitoring adverse events through the duration of the study, including a follow-up telephone call
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 ] [ Designated as safety issue: No ]
- 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 |
|---|---|
|
Experimental: (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: (PART A) dalfampridine-ER 10mg
Day 1, visit 2, subjects will receive dalfampridine-ER 10mg. Day 3, visit 3 subjects will receive placebo
|
|
Experimental: (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: (PART A) dalfampridine-ER 10mg
Day 1, visit 2, subjects will receive placebo. Day 3, visit 3, subjects will receive dalfampridine-ER 10mg
|
|
Experimental: (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: (PART B) dalfampridine-ER 10mg
Day 1, visit 2, subjects will be given 15 tablets dalfampridine-ER taken twice daily for 7 days and an additional 1 dose for 1 day. Day 15, visit 4, subjects will be given 15 tablets of placebo taken twice daily for 7 days and an additional 1 tablet for 1 day
|
|
Experimental: (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: (PART B) dalfampridine-ER 10mg
Day 1, visit 2, subjects will be given 15 tablets of placebo taken twice daily for 7 days and an additional 1 tablet for 1 day. Day 15, visit 4, subjects will be given 15 tablets dalfampridine-ER taken twice daily for 7 days and an additional 1 tablet for 1 day
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| Responsible Party: | Acorda Therapeutics |
| ClinicalTrials.gov Identifier: | NCT01468350 History of Changes |
| Other Study ID Numbers: | DALF-CP-1002 |
| Study First Received: | November 7, 2011 |
| Last Updated: | April 3, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Cerebral Palsy Paralysis Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms |
4-Aminopyridine Potassium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013