drugset / Trial / NCT02006160

Effects of Dalfampridine on Cognition in Multiple Sclerosis

NCT02006160

Phase 2/3 Completed 61 enrolled State University of New York at Buffalo
RandomizedParallel-groupQuadruple-blindTreatment

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

Timeline

Start
2011-12
Primary completion
2016-02
Completion
2016-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dalfampridine Small molecule 10 mg

Indications