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| Descriptive Information Fields | |||||
| Brief Title † | A Safety Study of Combination Treatment With Avonex and Zocor in Relapsing Remitting Multiple Sclerosis | ||||
| Official Title † | |||||
| Brief Summary | The purpose of this study is to determine if using Avonex in combination with Zocor is a safe and effective therapy for subjects with relapsing remitting multiple sclerosis. |
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| Detailed Description | Multiple Sclerosis (MS) is an inflammatory demyelinating disease of the Central Nervous System (CNS). There are many forms of MS; althoughthe majority are Relapsing Remitting (RRMS) representing approximately 80% of the cases. The disease appears to be more inflammatory in RRMS as manisfested by an increase inGadolinium enhancement on MRI and an increase in inflammatory bioassay markers. Zocor is in a class of drugs (statins) that are used to lower cholesterol. Statins also have an anti-inflammatory effect on the CNS. Zocor has been shown in a small clinical trial to reduce the number of new MRI-detected brain lesions over a six month treatment period in patients with RRMS. This study is to evaluate the safety of combining Avonex with Zocor for a a period of fourteen months in patients with RRMS and to evaluate the effect of treatment on new or enlarging lesions as measured by MRI. |
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| Study Phase | Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study | ||||
| Primary Outcome Measure † | 1. To evaluate the safety of combining Avonex with Zocor for a period of fourteen months in patients with RRMS 2. To evaluate the effect of treatment on MRI, specifically new or enlarging T2 lesions burden |
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| Secondary Outcome Measure † | 1. To evaluate the effect on Relapse Rates 2. To evaluate the effect on disease progression as measured with EDSS and MSFC |
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| Condition † | Relapsing Remitting Multiple Sclerosis | ||||
| Intervention † | Drug: Simvastatin | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 30 | ||||
| Start Date † | October 2005 | ||||
| Completion Date | |||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 55 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00242268 | ||||
| Organization ID | IST 03-09 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Alabama Neurology Associates, PC | ||||
| Collaborators †† | Biogen Idec | ||||
| Investigators † |
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| Information Provided By | Alabama Neurology Associates, PC | ||||
| Verification Date | September 2005 | ||||
| First Received Date † | October 19, 2005 | ||||
| Last Updated Date | December 6, 2005 | ||||