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A Safety Study of Combination Treatment With Avonex and Zocor in Relapsing Remitting Multiple Sclerosis

Primary Purpose

Relapsing Remitting Multiple Sclerosis

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Simvastatin
Sponsored by
Alabama Neurology Associates, PC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing Remitting Multiple Sclerosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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: ALT or AST > 2x upper limit of normal (ULN) CPK > 2x upper limit of normal (ULN) Total WBC < 3,000/mm3 No chronic infections (including HIV and Hepatitis B/C) may be present.

Sites / Locations

  • Alabama Neurology AssociatesRecruiting

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
October 19, 2005
Last Updated
December 6, 2005
Sponsor
Alabama Neurology Associates, PC
Collaborators
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT00242268
Brief Title
A Safety Study of Combination Treatment With Avonex and Zocor in Relapsing Remitting Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Alabama Neurology Associates, PC
Collaborators
Biogen

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing Remitting Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Simvastatin
Primary Outcome Measure Information:
Title
1. To evaluate the safety of combining Avonex with Zocor for a period of fourteen months in patients with RRMS
Title
2. To evaluate the effect of treatment on MRI, specifically new or enlarging T2 lesions burden
Secondary Outcome Measure Information:
Title
1. To evaluate the effect on Relapse Rates
Title
2. To evaluate the effect on disease progression as measured with EDSS and MSFC

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: ALT or AST > 2x upper limit of normal (ULN) CPK > 2x upper limit of normal (ULN) Total WBC < 3,000/mm3 No chronic infections (including HIV and Hepatitis B/C) may be present.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
William T. White, Pharm.D.
Phone
205-979-7555
Email
bwhite@sdr.us
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily S. Riser, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alabama Neurology Associates
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily S. Riser, MD

12. IPD Sharing Statement

Learn more about this trial

A Safety Study of Combination Treatment With Avonex and Zocor in Relapsing Remitting Multiple Sclerosis

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