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NCT01683838 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Oral Fampridine-Sustained Release (SR) for the Treatment of Spasticity Resulting From Spinal Cord Injury
A Phase 3 study, sponsored by Acorda Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 204
- Enrollment target
NCT01683838: Completed Phase 3 study, sponsored by Acorda Therapeutics.
NCT01683838 is a Phase 3 study that has completed, run by Acorda Therapeutics. The registered enrollment target is 204 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01683838, a Phase 3 study, has completed, sponsored by Acorda Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 204 participants
- Enrollment target
Study Summary
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.
Primary Outcome
The Ashworth evaluates the functioning of two lower extremity muscle groups, the hamstring and quadriceps muscles, while in the supine position. The test measures extension of the right and left hamstring muscle and flexion of the right and left quadriceps muscle using the following 5-point grading scale: 1=no increased tone; 2=slight increase in tone, giving a "catch" when the affected part is moved in flexion or extension; 3=more marked increase in tone, but affected part is easily flexed; 4=
Interventions
- DRUG Placebo
- DRUG Fampridine-SR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 204 participants |
| Start Date | 2002-06 |
| Est. Completion | 2004-02 |
| Phase | Phase 3 |
What the finished NCT01683838 record still lists
NCT01683838 is an interventional study that assigns participants to a tested intervention. The registered 204 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01683838 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01683838 about?
NCT01683838 is a clinical study titled "Safety and Efficacy of Oral Fampridine-Sustained Release (SR) for the Treatment of Spasticity Resulting From Spinal Cord Injury". 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 electrica...
What is the current status of trial NCT01683838?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 204 participants. The study started on 2002-06. Estimated completion is 2004-02.
What interventions are being tested in trial NCT01683838?
The interventions under investigation include: Placebo (DRUG), Fampridine-SR (DRUG).
Who is sponsoring clinical trial NCT01683838?
This trial is sponsored by Acorda Therapeutics, which has 36 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01683838's enrollment target sits among peer trials
204 1352nd of 2000 higher than 649 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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