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

Acorda Therapeutics213 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

213

Conditions

Spinal Cord Injury Muscle Spasticity

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (45)

Lakeshore Rehabilitation Hospital

Birmingham, Alabama, United States

Barrow Neurological Institute

Phoenix, Arizona, United States

Baptist Medical Center

Little Rock, Arkansas, United States

VA Palo Alto Health Care System

Palo Alto, California, United States

Neuro-Therapeutics, Inc

Pasadena, California, United States

Outcomes

Primary Outcomes

Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity

The Ashworth Score is the average rating (based on a scale of 1 to 5) of four lower extremity muscle groups; left and right knee flexors and extensors (hamstrings and quadriceps muscles). A higher Ashworth Score indicates a greater degree of abnormal muscle tone (spasticity) and a negative change in score indicates improvement.

Time frame: Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98

Double-blind Change From Baseline in Subject's Global Impression (SGI) of Treatment

This questionnaire asked the patient to evaluate the effects of investigational drug on his/her quality of life during the preceding week using a 7-point scale (from 1=terrible to 7=delighted). A positive change score in SGI indicates improved outcome.

Time frame: Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98