Status:
UNKNOWN
A Safety Study of Combination Treatment With Avonex and Zocor in Relapsing Remitting Multiple Sclerosis
Lead Sponsor:
Alabama Neurology Associates, PC
Collaborating Sponsors:
Biogen
Conditions:
Relapsing Remitting Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
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 appro...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00242268
Start Date
October 1 2005
Last Update
December 7 2005
Active Locations (1)
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1
Alabama Neurology Associates
Birmingham, Alabama, United States, 35209