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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Alabama Neurology Associates, PC.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Biogen Idec
Information provided by:
Alabama Neurology Associates, PC
ClinicalTrials.gov Identifier:
NCT00242268
First received: October 19, 2005
Last updated: December 6, 2005
Last verified: September 2005
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Alabama Neurology Associates, PC:

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

Estimated Enrollment: 30
Study Start Date: October 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or non-pregnant females age 18-55 who have clinically and laboratory definite relapsing-remitting MS using the MacDonald criteria.
  2. 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.

  3. The Kurtzke EDSS score must be between 0- 5.0.
  4. All subjects must give written consent prior to evaluation and testing.

Exclusion Criteria:

  1. Subjects with primary or secondary progressive MS.
  2. Female patients may not be pregnant, attempting pregnancy or breastfeeding.
  3. 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.
  4. Subjects unwilling or unable to give informed consent.
  5. Subjects that are NAB+ (titers > or = 20).
  6. 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
  7. No chronic infections (including HIV and Hepatitis B/C) may be present.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00242268

Contacts
Contact: William T. White, Pharm.D. 205-979-7555 bwhite@sdr.us

Locations
United States, Alabama
Alabama Neurology Associates Recruiting
Birmingham, Alabama, United States, 35209
Principal Investigator: Emily S. Riser, MD         
Sponsors and Collaborators
Alabama Neurology Associates, PC
Biogen Idec
Investigators
Principal Investigator: Emily S. Riser, MD
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00242268     History of Changes
Other Study ID Numbers: IST 03-09
Study First Received: October 19, 2005
Last Updated: December 6, 2005
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 22, 2014