Safety and Tolerability of Dalfampridine in Subjects With Cerebral Palsy

May 22, 2014 updated by: Acorda Therapeutics

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • California
      • Downey, California, United States, 90242
        • Rancho Los Amigos National Rehabilitation Center
      • Los Angeles, California, United States, 90095
        • UCLA/Orthopaedic Hospital Center for Cerebral Palsy
      • San Diego, California, United States, 92123
        • Rady Children's Hospital San Diego
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Rehabilitation Institute of Chicago
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Kennedy Krieger Institute at Johns Hopkins University
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Detroit Clinical Research Center
    • Minnesota
      • St. Paul, Minnesota, United States, 55101
        • Gillette Children's Specialty Healthcare
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri at Columbia
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Other: Placebo
Drug: dalfampridine-ER 10mg
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
Other: Placebo
Drug: dalfampridine-ER 10mg
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
Other: Placebo
Drug: dalfampridine-ER 10mg
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
Other: Placebo
Drug: dalfampridine-ER 10mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 31 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
up to 31 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acorda Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

November 7, 2011

First Submitted That Met QC Criteria

November 8, 2011

First Posted (Estimate)

November 9, 2011

Study Record Updates

Last Update Posted (Estimate)

June 24, 2014

Last Update Submitted That Met QC Criteria

May 22, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DALF-CP-1002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cerebral Palsy (CP)

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe