Safety and Tolerability of Dalfampridine in Subjects With Cerebral Palsy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Acorda Therapeutics
ClinicalTrials.gov Identifier:
NCT01468350
First received: November 7, 2011
Last updated: May 22, 2014
Last verified: May 2014

November 7, 2011
May 22, 2014
December 2011
January 2013   (final data collection date for primary outcome measure)
Safety and Tolerability of Dalfampridine-ER 10mg in Subjects With Cerebral Palsy (CP) [ Time Frame: up to 31 days ] [ Designated as safety issue: Yes ]

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
Improvement of sensorimotor function in patients with cerebral palsy after receiving one dose of dalfampridine-ER 10mg [ Time Frame: up to 7 days ] [ Designated as safety issue: No ]

Hand strength as measured by the grip and pinch tests

Manual dexterity as measured by the box and block test

Walking speed as measured by the timed 25 foot walk (T25FW)

- Administered at 4 time points on treatment days (Day 1, Visit 2 and Day 3, Visit 3): pre-dose, and post-dose hours 3,4, and 5 (± 20 min)

Complete list of historical versions of study NCT01468350 on ClinicalTrials.gov Archive Site
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)
Tolerability of dalfampridine-ER 10mg in patients with cerebral palsy [ Time Frame: up to 7 days ] [ Designated as safety issue: No ]
Tolerability will be assessed by monitoring adverse events through study duration, including follow-up telephone call on day 5 (+2days)
Not Provided
Not Provided
 
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

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Cerebral Palsy (CP)
  • Drug: dalfampridine-ER 10mg
  • Other: Placebo
  • 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
    Interventions:
    • 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
    Interventions:
    • 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
    Interventions:
    • 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
    Interventions:
    • Drug: dalfampridine-ER 10mg
    • Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
March 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01468350
DALF-CP-1002
No
Acorda Therapeutics
Acorda Therapeutics
Not Provided
Study Director: Enrique Carrazana, MD Acorda Therapeutics
Acorda Therapeutics
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP