Treating Multiple Sclerosis With Sirolimus, an Immune System Suppressor

Stopped early · Phase 1/Phase 2

Conditions studied: Multiple Sclerosis (MS) - Relapsing-remitting

In brief

The purpose of this study is to determine the safety and tolerability of the drug sirolimus in patients with multiple sclerosis (MS) who have failed other treatments.

Key facts

Study ID: NCT00095329
Run by: National Institute of Allergy and Infectious Diseases (NIAID)
People needed: 14
Starts: 2003-05-01
Expected to finish: 2005-03-01
Last updated by the study team: 2016-09-22

Who can join

Age: 18 and older, up to 58. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Relapsing-remitting MS
Evidence of demyelination on magnetic resonance imaging (MRI) scan
Expanded Disability Status Scale (EDSS) score between 0 and 6
Nonresponsive to beta-interferon or Glatiramer acetate therapy
Discontinuation of beta-interferon or Glatiramer acetate therapy within 1 month prior to study entry
Willing to use acceptable methods of contraception

You may not qualify if…

Primary progressive MS
Prior treatment with immunosuppressants
Steroid therapy within 1 month prior to study entry
Evidence of active infection or cancer
Heart or hematologic dysfunction
High levels of lipids in the blood
Use of lipid-lowering agents
History of cirrhosis or liver disease requiring treatment
History of hepatitis B or C
Active cytomegalovirus infection
Kidney disease requiring treatment
Active lung disease
Diabetes
Hyperthyroidism
HIV infection
Tuberculosis
History of alcohol or drug abuse within 6 months prior to study entry
Claustrophobia or inability to undergo MRI
Pregnancy or breast-feeding

Where it is running

Center for Neurological Diseases, Brigham and Women's Hospital, Harvard Medical School — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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