Double-Blind, Placebo-Controlled Study of Rifampicin in Multiple System Atrophy

Status: Terminated
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study was to determine whether Rifampicin was effective in slowing or reversing the progression of multiple system atrophy (MSA). Research studies indicate that there is an abnormality in protein synthesis and structure in parts of the brain responsible for MSA (protein misfolding) and the drug Rifampicin could potentially prevent or reverse this protein alteration. The study was done on participants with early MSA. The study consisted of taking the drug 2 times a day for 12 months. Participants underwent an evaluation of symptoms and function and will underwent a neurologic examination at the beginning of the study, at 6 months and at 12 months. They were also be contacted at 3 and 9 months by telephone. Studies were done at 10 participating sites.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 80
Healthy Volunteers: No
View:

• Participants aged 30-80 years old with a diagnosis of Possible or Probable MSA of the parkinsonian subtype (MSA-P) or cerebellar subtype (MSA-C) according to The Gilman Criteria (2008).

• Participants who are less than 4 years from the time of documented MSA diagnosis.

• Participants with an anticipated survival of at least 3 years in the opinion of the investigator.

• Participants who are willing and able to give informed consent.

• Normal cognition as assessed by Mini-Mental State Examination (MMSE). We will require a value >24.

• Patients should be able to swallow capsules whole.

Locations
United States
California
UCLA Medical Center
Los Angeles
University of California, San Diego
San Diego
Florida
Mayo Clinic
Jacksonville
University of South Florida
Tampa
Massachusetts
Harvard Medical School
Boston
Michigan
University of Michigan
Ann Arbor
Minnesota
Mayo Clinic
Rochester
New York
New York University
New York
Tennessee
Vanderbilt University
Nashville
Texas
University of Texas Southwestern Medical Center
Dallas
Time Frame
Start Date: March 2011
Completion Date: January 2013
Participants
Target number of participants: 100
Treatments
Active Comparator: Rifampicin
Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
Placebo Comparator: Placebo
Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
Authors
Sponsors
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS), Vanderbilt University, Rare Disease Research Network Autonomic Consortium
Leads: Phillip Low

This content was sourced from clinicaltrials.gov

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