Treating Multiple Sclerosis With Sirolimus, an Immune System Suppresso
A Phase I/II, Open-Label Pilot Trial to Evaluate the Safety of Rapamune (Sirolimus) in Patients With Multiple Sclerosis
What it found
The trial ended early for another reason (see below).
Reason given: Due to slow recruitment.
This trial finished 21 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Sirolimus
FK506-binding protein 1A inhibitor
What it measured
Main measures
Safety of sirolimus, including number of lesions detected by brain MRI
MRI lesionsSafetyTolerability of sirolimus
SafetyMean number of new and overall total number of gadolinium-enhancing lesions reported on sequential brain MRIs
MRI lesions
Other measures (2)
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
MRI lesionsEffect of sirolimus therapy on the immune function of patients with relapsing-remitting multiple sclerosis (RRMS)
Who could take part
Relapsing MS · 18 to 58 · EDSS 0 to 6
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Background
Meier DS, Weiner HL, Khoury SJ, Guttmann CR. Magnetic resonance imaging surrogates of multiple sclerosis pathology and their relationship to central nervous system atrophy. J Neuroimaging. 2004 Jul;14(3 Suppl):46S-53S. doi: 10.1177/1051228404266268.Background
Gonsette RE. New immunosuppressants with potential implication in multiple sclerosis. J Neurol Sci. 2004 Aug 15;223(1):87-93. doi: 10.1016/j.jns.2004.04.025.Background
Lucchinetti C, Bruck W. The pathology of primary progressive multiple sclerosis. Mult Scler. 2004 Jun;10 Suppl 1:S23-30. doi: 10.1191/1352458504ms1027oa.Background
Kovarik JM, Burtin P. Immunosuppressants in advanced clinical development for organ transplantation and selected autoimmune diseases. Expert Opin Emerg Drugs. 2003 May;8(1):47-62. doi: 10.1517/14728214.8.1.47.
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History
Started
May 2003
Main results due
Mar 2005
Finished
Mar 2005