Simvastatin in Relapsing Remitting Multiple Sclerosis - Clinical Trials Registry

Study Overview

Status

Unknown

Conditions

Relapsing Remitting Multiple Sclerosis

Intervention / Treatment

Drug: Simvastatin

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.

Study Type

Interventional

Enrollment

30

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Alabama
  - Birmingham, Alabama, United States, 35209
    - Recruiting
    - Alabama Neurology Associates
    - Principal Investigator:
      
      Emily S. Riser, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Male or non-pregnant females age 18-55 who have clinically and laboratory definite relapsing-remitting MS using the MacDonald 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:
- or = 1 documented clinical relapse in past 12 months while on interferon therapy. For eligibility, a pre-study relapse is defined as neurologic symptoms and signs documented by review of the history with the subject or in the medical record, of sufficient severity and duration to be determined by the investigator as consistent with an acute MS relapse.
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.
The Kurtzke EDSS score must be between 0- 5.0.
All subjects must give written consent prior to evaluation and testing.

Exclusion Criteria:

Subjects with primary or secondary progressive MS.
Female patients may not be pregnant, attempting pregnancy or breastfeeding.
Female subjects must use an acceptable form of contraception during the study as defined by the investigators. The rhythm method is not to be used as the sole method of contraception.
Subjects unwilling or unable to give informed consent.
Subjects that are NAB+ (titers > or = 20).
Abnormal baseline blood test exceeding any of the limits defined below:
1. ALT or AST > 2x upper limit of normal (ULN)
2. CPK > 2x upper limit of normal (ULN)
3. Total WBC < 3,000/mm3
No chronic infections (including HIV and Hepatitis B/C) may be present.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
1. To evaluate the effect on Relapse Rates
2. To evaluate the effect on disease progression as measured with EDSS and MSFC

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alabama Neurology Associates, PC

Collaborators

Biogen

Investigators

Principal Investigator: Emily S. Riser, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Study Registration Dates

First Submitted

October 19, 2005

First Submitted That Met QC Criteria