NCT03092544

Investigating Indirect Mechanism of Neuroprotection of Tecfidera® (Dimethyl Fumarate) in RRMS and Progressive Patients

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Multiple Sclerosis Center of Northeastern New York · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purposes of this study is to identify types of bacteria that reside in the intestine of healthy individuals and compare them to individuals with Multiple Sclerosis (MS). There has been a lot of research in other autoimmune diseases which has demonstrated the importance of stomach "gut" bacteria because it has an important relationship with the immune system, but this has never been studied in MS patients. In this study investigators aim to show differences in the gut bacteria between healthy individuals and those with MS, to provide a basis for future research studying how diet can affect MS through its effects on the "gut" bacteria. Additionally, this study will be looking at the effects of dimethyl fumarate on cerebrospinal fluid, plasma and MRI in MS patients taking dimethyl fumarate as compared to those with MS not on dimethyl fumarate or other disease modifying therapy and those who do not have MS (normal controls).

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	dimethyl fumarate	Active drug

Timeline

• Start date: 2015-02-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2017-03-28
• Last updated: 2018-03-22

Locations

1 site across 1 country: United States