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Completed

NCT Number: NCT01468350

Safety and Tolerability of Dalfampridine in Subjects With Cerebral Palsy

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

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Key information

Conditions

Cerebral Palsy (CP) Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dalfampridine-ER 10mg

Drug

Placebo

Other

Primary outcomes

  1. 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 outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Acorda Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 9, 2011
Registry last updated
Jun 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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