Status:
TERMINATED
Treating Multiple Sclerosis With Sirolimus, an Immune System Suppressor
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Autoimmunity Centers of Excellence
Conditions:
Multiple Sclerosis (MS) - Relapsing-remitting
Eligibility:
All Genders
18-58 years
Phase:
PHASE1
PHASE2
Brief Summary
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.
Detailed Description
MS is a chronic autoimmune disease of the central nervous system in which myelin, the protein sheath that protects nerve cells, is degraded by T cells and macrophages, leading to an eventual loss of n...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2005
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00095329
Start Date
May 1 2003
End Date
March 1 2005
Last Update
September 22 2016
Active Locations (1)
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1
Center for Neurological Diseases, Brigham and Women's Hospital, Harvard Medical School
Boston, Massachusetts, United States, 02115