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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 is a Phase 2 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 53 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01337986
The ClinicalTrials.gov registry entry for NCT01337986 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Dalfampridine/Placebo is the first listed.
NCT01337986 reports 0 study locations.
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.
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