drugset / Trial / NCT02981082

Dimethyl Fumarate (DMF) in Systemic Sclerosis-Associated Pulmonary Arterial Hypertension

NCT02981082

Phase 1 Terminated 6 enrolled Robert Lafyatis Biogen · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

A double-blinded, placebo-controlled study of Dimethyl fumarate (DMF) in 34 Systemic Sclerosis-Pulmonary Hypertension (SSc-PAH) patients. The study will determine safety and the primary outcome variability for DMF in treating SSc-PAH; the primary outcome of clinical efficacy in this pilot trial will be improvement in 6-minute walk distance (6MWD).

Timeline

Start
2016-12
Primary completion
2020-02-10
Completion
2020-02-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator dimethyl fumarate Unknown 120 mg Oral
Comparator dimethyl fumarate Unknown 240 mg Oral