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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00095329 |
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.
Condition | Intervention | Phase |
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Multiple Sclerosis |
Drug: Sirolimus |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II, Open-Label Pilot Trial to Evaluate the Safety of Rapamune (Sirolimus) in Patients With Multiple Sclerosis |
Estimated Enrollment: | 13 |
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 neurologic function. MS can be classified as either relapsing-remitting, in which patients experience worsening in symptoms followed by partial or complete recovery of function; or progressive, in which patients have a gradual increase in symptoms, with or without relapses. Standard treatments used to treat relapsing-remitting MS are only modestly effective and may be associated with significant toxicity. There is a need to develop therapies with lower toxicities that can be administered early during the course of disease and have the potential to stop disease progression altogether. Sirolimus has been demonstrated to provide potent immunosuppression in recent clinical trials involving kidney transplantation, and may help people with autoimmune diseases like MS. This study will determine the benefit of sirolimus in MS patients.
Blood and urine collection will occur at screening. Participants will take daily doses of sirolimus for 6 months. There will be nine study visits; they will occur at Days 14, 28, 42, 56, 90, 120, 150, 180, and 225. Medication adverse events, concomitant medications, and vital signs will be recorded at Visits 1 through 8. At all visits, patient compliance to the sirolimus regimen will be measured, and blood and urine collection will occur. Physical and neurological exams, magnetic resonance imaging (MRI) brain scans, MS status tests, and a chest x-ray will be conducted at selected times throughout the study.
Ages Eligible for Study: | 18 Years to 58 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Center for Neurological Diseases, Brigham and Women's Hospital, Harvard Medical School | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Samia J. Khoury, MD | Center for Neurological Diseases, Brigham and Women's Hospital, Harvard Medical School |
Study ID Numbers: | DAIT AMS02 |
Study First Received: | November 2, 2004 |
Last Updated: | September 8, 2006 |
ClinicalTrials.gov Identifier: | NCT00095329 |
Health Authority: | United States: Federal Government |
MS Treatment Failure |
Sirolimus Autoimmune Diseases Multiple Sclerosis Demyelinating Diseases Clotrimazole Miconazole |
Tioconazole Demyelinating Autoimmune Diseases, CNS Demyelinating diseases Sclerosis Autoimmune Diseases of the Nervous System |
Anti-Infective Agents Immune System Diseases Immunologic Factors Antineoplastic Agents Nervous System Diseases Physiological Effects of Drugs Antibiotics, Antineoplastic |
Immunosuppressive Agents Pharmacologic Actions Anti-Bacterial Agents Pathologic Processes Therapeutic Uses Antifungal Agents |