Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00095329
Status:
TERMINATED
Last Update Posted:
2016-09-22
First Post:
2004-11-02
Brief Title:
Treating Multiple Sclerosis With Sirolimus an Immune System Suppressor
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase III Open-Label Pilot Trial to Evaluate the Safety of Rapamune Sirolimus in Patients With Multiple Sclerosis
Status:
TERMINATED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to slow recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None