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

NCT02981082 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2022-03-17

Study results available
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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).

Conditions

Interventions

DRUG

Dimethyl Fumarate (DMF)

Dimethyl Fumarate (DMF) is a prescription medicine used to treat relapsing multiple sclerosis.

DRUG

Placebo Oral Tablet

Sugar pill manufactured to mimic Dimethyl Fumarate (DMF)

Sponsors & Collaborators

  • Biogen

    collaborator INDUSTRY

  • Robert Lafyatis

    lead OTHER

Principal Investigators

  • Robert A Lafyatis, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2020-02-10
Completion
2020-02-10

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02981082 on ClinicalTrials.gov