CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 53 enrolled
Drug / intervention
Dalfampridine/Placebo +1 moredrug
Likely dose
Dalfampridine/Placebo 10mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01337986
NCT01337986Phase 3Completed
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Dalfampridine After Optic Neuritis to Improve Visual Function in Multiple Sclerosis

Washington University School of Medicine·interventional·Posted Apr 19, 2011·Updated Jan 30, 2020

In Brief

A Phase 3 clinical trial evaluating Dalfampridine/Placebo and Placebo/Dalfampridine for Multiple Sclerosis and Optic Neuritis. Completed, enrolled 53 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis, Optic Neuritis
CountriesUnited States
CollaboratorsAcorda Therapeutics

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 19, 2011
Enrollment StartMay 1, 2011
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 15.2 years ago

Interventions

Dalfampridine/Placebodrug

Weeks 1-3: Dalfampridine 10mg (1 tablet) every 12 hours for 3 weeks. Weeks 4-5: 2 weeks of wash-out. Weeks 5-8: Placebo (sugar pill) 1 tablet every 12 hours for 3 weeks.

Placebo/Dalfampridinedrug

Weeks 1-3: Placebo (sugar pill) 1 tablet every 12 hours for 3 weeks. Weeks 4-5: 2 weeks of wash-out. Weeks 6-8: Dalfampridine 10mg (1 tablet) every 12 hours for 3 weeks.