CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 61 enrolled
Drug / intervention
dalfampridine +1 moredrug
Likely dose
dalfampridine 10 mgfrom 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/NCT02006160
NCT02006160Phase 3Completed

Effects of Dalfampridine on Cognition in Multiple Sclerosis

State University of New York at Buffalo·interventional·Posted Dec 10, 2013·Updated Oct 1, 2020

In Brief

A Phase 3 clinical trial evaluating dalfampridine and placebo for Multiple Sclerosis. Completed, enrolled 61 participants across 1 site.

Detailed Summary

Cognitive impairment is common in multiple sclerosis (MS) and has devastating impact on functional activities. There is great demand for medications that will enhance cognitive capacity in MS patients. To date, there is no evidence for improvement in cognition following treatment with aminopyridines, but the few studies on the topic included neuropsychological (NP) tests as secondary or tertiary outcomes, and were methodologically flawed. Dalfampridine may enhance cognition by direct pharmacological mechanisms, and should have effects on motor outcomes as in prior studies. By combining cognition and motor outcomes in the proposed study, the investigators will evaluate if the same patients with positive effects show beneficial responses on motor outcomes including physical activity and if such motor outcomes mediate and/or moderate cognitive improvements with dalfampridine

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 10, 2013
Enrollment StartDec 1, 2011
Primary CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 12.6 years ago

Interventions

dalfampridinedrug

10 mg bid

placebodrug

10 mg bid