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Safety and Tolerability of Dalfampridine in Subjects With Cerebral Palsy

Primary Purpose

Cerebral Palsy (CP)

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
dalfampridine-ER 10mg
Placebo
Sponsored by
Acorda Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy (CP)

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • Rancho Los Amigos National Rehabilitation Center
  • UCLA/Orthopaedic Hospital Center for Cerebral Palsy
  • Rady Children's Hospital San Diego
  • Rehabilitation Institute of Chicago
  • Kennedy Krieger Institute at Johns Hopkins University
  • Detroit Clinical Research Center
  • Gillette Children's Specialty Healthcare
  • University of Missouri at Columbia
  • Cleveland Clinic
  • Swedish Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Placebo Comparator

Placebo Comparator

Placebo Comparator

Arm Label

(PART A) AB: dalfampridine-ER 10mg then placebo

(PART A) BA: placebo then dalfampridine-ER 10mg

(PART B) AB: dalfampridine-ER 10mg then placebo

(PART B) BA: Placebo then dalfampridine-ER 10mg

Arm Description

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

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

Each subject randomized to the AB arm will receive multiple doses of (A) dalfampridine-ER 10mg and multiple doses of (B) placebo

Each subject randomized to the BA arm will receive multiple doses of (B) placebo, and multiple doses of (A) dalfampridine-ER 10mg

Outcomes

Primary Outcome Measures

Safety and Tolerability of Dalfampridine-ER 10mg in Subjects With Cerebral Palsy (CP)
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
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)

Full Information

First Posted
November 7, 2011
Last Updated
May 22, 2014
Sponsor
Acorda Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT01468350
Brief Title
Safety and Tolerability of Dalfampridine in Subjects With Cerebral Palsy
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acorda Therapeutics

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy (CP)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
(PART A) AB: dalfampridine-ER 10mg then placebo
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
(PART A) BA: placebo then dalfampridine-ER 10mg
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
(PART B) AB: dalfampridine-ER 10mg then placebo
Arm Type
Placebo Comparator
Arm Description
Each subject randomized to the AB arm will receive multiple doses of (A) dalfampridine-ER 10mg and multiple doses of (B) placebo
Arm Title
(PART B) BA: Placebo then dalfampridine-ER 10mg
Arm Type
Placebo Comparator
Arm Description
Each subject randomized to the BA arm will receive multiple doses of (B) placebo, and multiple doses of (A) dalfampridine-ER 10mg
Intervention Type
Drug
Intervention Name(s)
dalfampridine-ER 10mg
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Safety and Tolerability of Dalfampridine-ER 10mg in Subjects With Cerebral Palsy (CP)
Description
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
Time Frame
up to 31 days
Secondary Outcome Measure Information:
Title
Measure the Effects of Both Single and Multiple Doses of Dalfampridine-ER 10 mg on Sensorimotor Function
Description
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)
Time Frame
up to 31 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enrique Carrazana, MD
Organizational Affiliation
Acorda Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Rancho Los Amigos National Rehabilitation Center
City
Downey
State/Province
California
ZIP/Postal Code
90242
Country
United States
Facility Name
UCLA/Orthopaedic Hospital Center for Cerebral Palsy
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Rady Children's Hospital San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Rehabilitation Institute of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Kennedy Krieger Institute at Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Detroit Clinical Research Center
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Gillette Children's Specialty Healthcare
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
University of Missouri at Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28131322
Citation
Bethoux F, Fatemi A, Fowler E, Marciniak C, Mayadev A, Waksman J, Zackowski K, Suarez G, Blight AR, Rabinowicz AL, Carrazana E. Safety, Tolerability, and Sensorimotor Effects of Extended-release Dalfampridine in Adults With Cerebral Palsy: A Pilot Study. Clin Ther. 2017 Feb;39(2):337-346. doi: 10.1016/j.clinthera.2016.12.015. Epub 2017 Jan 25.
Results Reference
derived

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Safety and Tolerability of Dalfampridine in Subjects With Cerebral Palsy

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