Phase 3
Completed N=300
Study of Oral Fampridine-SR in Multiple Sclerosis
Source: ClinicalTrials.gov NCT00127530 ↗Enrolled (actual)
300
Serious AEs
5.3%
Results posted
May 2011
Primary outcomePrimary: Timed Walk Responders (Patients Who Showed Consistent Improvement on the Timed-25 Foot Walk) — 6; 78 Participants
Summary
To assess the safety and efficacy of 10 milligram (mg) twice a day (b.i.d.) Fampridine-SR in patients diagnosed with multiple sclerosis (MS), in a double-blind, placebo-controlled, parallel group study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Timed Walk Responders (Patients Who Showed Consistent Improvement on the Timed-25 Foot Walk) |
6; 78 | — |
| SECONDARY Lower Extremity Manual Muscle Test; Ashworth Score for Spasticity |
— | — |
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of multiple sclerosis
- Are able to walk with or without an assistive device
Exclusion Criteria
- Pregnancy, breastfeeding or females of childbearing potential not using adequate birth control
- Participating in other investigational drug trials
- A medical history or clinical findings that preclude entry into the study
- A medication history that precludes entry into the study
- Previously treated with 4-aminopyridine (4-AP)
Data sourced from ClinicalTrials.gov (NCT00127530). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.