A Safety Study of Combination Treatment With Avonex and Zocor in Relapsing Remitting Multiple Sclerosis
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 19, 2005
CompletedFirst Posted
Study publicly available on registry
October 20, 2005
CompletedDecember 7, 2005
September 1, 2005
October 19, 2005
December 6, 2005
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
1. To evaluate the effect on Relapse Rates
2. To evaluate the effect on disease progression as measured with EDSS and MSFC
Interventions
Eligibility Criteria
You may qualify if:
- 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 = 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alabama Neurology Associates, PClead
- Biogencollaborator
Study Sites (1)
Alabama Neurology Associates
Birmingham, Alabama, 35209, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emily S. Riser, MD
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 19, 2005
First Posted
October 20, 2005
Study Start
October 1, 2005
Last Updated
December 7, 2005
Record last verified: 2005-09