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Safety and Efficacy of Oral Fampridine-SR for the Treatment of Spasticity Resulting From Spinal Cord Injury

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Acorda Therapeutics
ClinicalTrials.gov Identifier:
NCT01683838
First received: August 24, 2012
Last updated: September 10, 2012
Last verified: September 2012
History of Changes
  Purpose

Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with spinal cord injury, some fibers may be destroyed at the site of injury, while others remain connected but do not work correctly to carry electrical impulses. As a result, subjects with an incomplete spinal cord injury may have spasticity which is muscle spasms or muscle stiffness that makes movement difficult. Fampridine-SR is an experimental drug that increases the ability of the nerve to conduct electrical impulses. This study will examine the effects of Fampridine-SR on moderate to severe lower-limb spasticity, as well as the effects on bodily functions such as bladder control, bowel function and sexual function. The study will also examine the possible risks of taking Fampridine-SR.


Condition Intervention Phase
Spinal Cord Injury
Muscle Spasticity
 Drug: Fampridine-SR
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Double-Blind, Placebo-Controlled, 12-Week Parallel Group Study to Evaluate Safety and Efficacy of Oral Fampridine-SR in Subjects With Moderate to Severe Spasticity Resulting From Chronic, Incomplete Spinal Cord Injury

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Acorda Therapeutics:

Primary Outcome Measures:
  • Change from baseline in Ashworth score evaluating spasticity [ Time Frame: Baseline stable dose treatment (Average of days 7-14) and baseline double blind treatment period (average of days 28-98) ] [ Designated as safety issue: No ]
    The Ashworth score is the average rating by the clinician of four lower extremity muscle groups (left and right knee flexors and extensors), each evaluated on a 1-5 unit ordinal scale

  • Change from baseline in Subject's Global Impression (SGI) of treatment [ Time Frame: Baseline stable dose treatment (Average of days 7-14) and baseline double blind treatment period (average of days 28-98) ] [ Designated as safety issue: No ]
    The SGI is a 7-unit ordinal scale used by the subject to evaluate the effects of study medication on his/her quality of life during the preceding week, with higher scores denoting greater satisfaction. A positive change score in SGI signifies improved outcome


Enrollment: 204
Study Start Date: June 2002
Study Completion Date: February 2004
Primary Completion Date: November 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: fampridine-SR 50mg/day Drug: Fampridine-SR
25mg bid (twice daily)
Placebo Comparator: Placebo Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Incomplete traumatic Spinal Cord Injury (at least 18 months prior and stable for 6 months)
  • Moderate to severe lower-limb spasticity
  • Able to give informed consent and willing to comply with protocol

Exclusion Criteria:

  • Pregnancy
  • History of seizures
  • Existing or history of frequent Urinary Tract Infections
  • History of drug or alcohol abuse
  • Allergy to pyridine-containing substances
  • Received a botox injection 4 months prior to study
  • Received an investigational drug within 30 days
  • Previously treated with 4-aminopyridine (4-AP)
  • Not on stable medication dosing in 3 weeks prior to study
  • Abnormal ECG or laboratory value at screening
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01683838

  Show 30 Study Locations
Sponsors and Collaborators
Acorda Therapeutics
Investigators
Study Director: Andrew Blight, MD Acorda Therapeutics
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT01683838     History of Changes
Other Study ID Numbers: SCI-F302
Study First Received: August 24, 2012
Last Updated: September 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Acorda Therapeutics:
spinal cord injury
muscle spasticity

Additional relevant MeSH terms:
Muscle Spasticity
Spinal Cord Injuries
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Spinal Cord Diseases
 Central Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
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 16, 2013