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NCT01337986 · ClinicalTrials.gov registry record · Phase 2
Ampyra for Optic Neuritis in Multiple Sclerosis
A Phase 2 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 53
- Enrollment target
NCT01337986: Completed Phase 2 study, sponsored by Washington University School of Medicine.
NCT01337986 is a Phase 2 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 53 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01337986, a Phase 2 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 53 participants
- Enrollment target
Study Summary
Fifty subjects will be enrolled in this Phase II, investigator-initiated, randomized and blinded cross-over trial of dalfampridine of 8 weeks duration The study will test the hypothesis that dalfampridine, when administered to subjects with incomplete visual recovery after optic neuritis from MS, will result in symptomatic improvement in visual function. The study will consist of one screening/baseline visit, one visit during treatment with active drug, and one visit on placebo. After the baseline visit, subjects will be randomly assigned to receive study medication or placebo for the first three weeks, followed by a two week wash-out, and then treatment reallocation for the latter three weeks.
Primary Outcome
Per Protocol Analysis to assess differences in EDTRS 5% Contrast Sensitivity (LogMAR) Scores at visits 2 and 3 Relative to Visit 1 on patients taking Dalfampridine vs Placebo.
Interventions
- DRUG Dalfampridine/Placebo
- DRUG Placebo/Dalfampridine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2011-05 |
| Est. Completion | 2013-12 |
| Phase | Phase 2 |
What the finished NCT01337986 record still lists
NCT01337986 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Dalfampridine/Placebo is the first listed.
NCT01337986 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01337986 about?
NCT01337986 is a clinical study titled "Ampyra for Optic Neuritis in Multiple Sclerosis". Fifty subjects will be enrolled in this Phase II, investigator-initiated, randomized and blinded cross-over trial of dalfampridine of 8 weeks duration The study will test the hypothesis that dalfampridine, when administered to subjects with incomplete visual recovery after optic neuritis from MS, wi...
What is the current status of trial NCT01337986?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2011-05. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01337986?
The interventions under investigation include: Dalfampridine/Placebo (DRUG), Placebo/Dalfampridine (DRUG).
Who is sponsoring clinical trial NCT01337986?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01337986's enrollment target sits among peer trials
53 1171st of 2000 higher than 820 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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