Treating Multiple Sclerosis With Sirolimus, an Immune System Suppressor

• Register: ClinicalTrials.gov
• Last refreshed on: 3 October 2016
• Main ID: NCT00095329
• Date of registration: 02/11/2004
• Prospective Registration: No
• Primary sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Public title: Treating Multiple Sclerosis With Sirolimus, an Immune System Suppressor
• Scientific title: A Phase I/II, Open-Label Pilot Trial to Evaluate the Safety of Rapamune (Sirolimus) in Patients With Multiple Sclerosis
• Date of first enrolment: May 2003
• Target sample size: 14
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00095329
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Contacts

• Name: Samia J. Khoury, MD
• Affiliation: Center for Neurological Diseases, Brigham and Women's Hospital, Harvard Medical School

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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



Age minimum: 18 Years
Age maximum: 58 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Multiple Sclerosis (MS) - Relapsing-remitting

Intervention(s)

Biological: sirolimus

Primary Outcome(s)

Safety of sirolimus, including number of lesions detected by brain MRI [Time Frame: Yes]

Mean number of new and overall total number of gadolinium-enhancing lesions reported on sequential brain MRIs [Time Frame: No]

Tolerability of sirolimus [Time Frame: No]

Secondary Outcome(s)

Efficacy, as measured by change in the mean number of new and overall total number of gadolinium-enhancing lesions on pre-treatment brain MRIs, compared to post-treatment [Time Frame: No]

Effect of sirolimus therapy on the immune function of patients with relapsing-remitting multiple sclerosis (RRMS) [Time Frame: No]

Secondary ID(s)

DAIT AMS02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Autoimmunity Centers of Excellence