NCT00041717

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

Completed Phase 3 Results posted Last updated 6 January 2020

What this trial tests

Phase 3 trial testing Fampridine-SR in Spinal Cord Injury in 213 participants. Completed in 1 May 2004.

Timeline

1 July 2002

Primary endpoint
1 February 2004

1 May 2004

Quick facts

Lead sponsor	Acorda Therapeutics
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	213
Start date	1 July 2002
Primary completion	1 February 2004
Estimated completion	1 May 2004
Sites	45 locations across United States, Canada

Drugs / interventions tested

• Fampridine-SR — full drug profile →
• Placebo

Conditions studied

• Spinal Cord Injury — all drugs for Spinal Cord Injury →
• Muscle Spasticity — all drugs for Muscle Spasticity →

Sponsor

Acorda Therapeutics — full company profile →

Who can join

Adults 18 to 70, any sex, with Spinal Cord Injury or Muscle Spasticity. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity
  Time frame: Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98
  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.
• Double-blind Change From Baseline in Subject's Global Impression (SGI) of Treatment
  Time frame: Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98
  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.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Spinal cord injury: molecular mechanisms and therapeutic interventions.
   Hu X, Xu W, Ren Y, Wang Z, et al · · 2023 · cited 400× · PMID 37357239 · DOI 10.1038/s41392-023-01477-6
2. A quantitative analysis of clinical trial designs in spinal cord injury based on ICCP guidelines.
   Sorani MD, Beattie MS, Bresnahan JC. · · 2012 · cited 4× · PMID 22369673 · DOI 10.1089/neu.2011.2162