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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 is a Phase 3 study that has completed, run by Acorda Therapeutics. The registered enrollment target is 204 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01683838
The ClinicalTrials.gov registry entry for NCT01683838 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 204 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Acorda Therapeutics, which has 36 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01683838 reports 0 study locations.
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.
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