Safety and Efficacy of Oral Fampridine-Sustained Release (SR) for the Treatment of Spasticity Resulting From Spinal Cord Injury
Public ClinicalTrials.gov record NCT01683838. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT01683838
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 204 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 2002 (Type not available)
- Primary completion
- Nov 2003 (Actual)
- Completion
- Feb 2004 (Actual)
- Last update posted
- Aug 25, 2017
2002 – 2004
United States locations
- U.S. sites
- 27
- U.S. states
- 17
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UAB School of Medicine, 190 Spain Rehab Center | Birmingham | Alabama | 35233 | — |
| Long Beach VA Medical Center | Long Beach | California | 90822 | — |
| University of California, Davis | Sacramento | California | 95817 | — |
| Santa Clara Valley Medical Center | San Jose | California | 95128 | — |
| Craig Hospital | Englewood | Colorado | 80110 | — |
| Hospital for Special Care | New Britain | Connecticut | 06503 | — |
| Hines VA Hospital | Hines | Illinois | 60141 | — |
| Boston University Medical Center | Boston | Massachusetts | 02118 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Rehabilitation Institute of Michigan | Detroit | Michigan | 48201 | — |
| Minneapolis VA Hospital | Minneapolis | Minnesota | 55417 | — |
| University of Missouri | Columbia | Missouri | 65212 | — |
| St. Louis University | St Louis | Missouri | 63104 | — |
| University of Rochester/Strong Memorial Hospital | Rochester | New York | 14642 | — |
| SUNY Upstate Clinical Trials Office | Syracuse | New York | 13045 | — |
| Helen Hayes Hospital | West Haverstraw | New York | 13045 | — |
| Charlotte Institute of Rehabilitation | Charlotte | North Carolina | 28203 | — |
| Coastal AHEC | Wilmington | North Carolina | 28402 | — |
| Ohio State University | Columbus | Ohio | 43210 | — |
| Miami Valley Hospital- Rehabilitation Institute of Medicine | Dayton | Ohio | 45409 | — |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | — |
| VA North Texas Health Care System | Dallas | Texas | 75216 | — |
| Southwestern Medical Center at Dallas | Dallas | Texas | 75390 | — |
| INOVA Institute of Research and Education | Falls Church | Virginia | 22042 | — |
| Medical College of Virginia/VCU | Richmond | Virginia | 23298 | — |
| University of Washington Medical Center, Dept. of Rehabilitation | Seattle | Washington | 98195 | — |
| Wood VA Medical Center | Milwaukee | Wisconsin | 53295 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01683838, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 25, 2017 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01683838 live on ClinicalTrials.gov.