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| Sponsor: | Alabama Neurology Associates, PC |
|---|---|
| Collaborator: |
Biogen Idec |
| Information provided by: | Alabama Neurology Associates, PC |
| ClinicalTrials.gov Identifier: | NCT00242268 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Relapsing Remitting Multiple Sclerosis |
Drug: Simvastatin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study |
| Estimated Enrollment: | 30 |
| Study Start Date: | October 2005 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects must be taking some form of interferon therapy (Rebif, Avonex or Betaseron) for a duration of 12 months with documented breakthrough disease as defined:
The relapse does not need to have been treated to qualify. the timing of the relapse is defined based on the onset of symptoms.
OR
> or = 1 documented Gd-enhancing lesion on cranial or spinal MRI. The presence of a Gd-enhancing lesion must be documented either by a report in the medical record or review of the films by the investigator.
Exclusion Criteria:
Abnormal baseline blood test exceeding any of the limits defined below:
Contacts and Locations| Contact: William T. White, Pharm.D. | 205-979-7555 | bwhite@sdr.us |
| United States, Alabama | |
| Alabama Neurology Associates | Recruiting |
| Birmingham, Alabama, United States, 35209 | |
| Principal Investigator: Emily S. Riser, MD | |
| Principal Investigator: | Emily S. Riser, MD | Unaffiliated |
More Information
| Study ID Numbers: | IST 03-09 |
| Study First Received: | October 19, 2005 |
| Last Updated: | December 6, 2005 |
| ClinicalTrials.gov Identifier: | NCT00242268 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Antimetabolites Autoimmune Diseases Molecular Mechanisms of Pharmacological Action Demyelinating Diseases Immune System Diseases Simvastatin Antilipemic Agents Nervous System Diseases Enzyme Inhibitors Sclerosis |
Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Multiple Sclerosis, Relapsing-Remitting Pharmacologic Actions Multiple Sclerosis Pathologic Processes Therapeutic Uses Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |