A Combination Trial of Copaxone Plus Estriol in Relapsing Remitting Multiple Sclerosis (RRMS) (Estriol in MS)
This study is ongoing, but not recruiting participants.
Sponsor:
University of California, Los Angeles
Collaborators:
Washington University School of Medicine
University of Texas Southwestern Medical Center
Ohio State University
University of Medicine and Dentistry New Jersey
University of Chicago
Western Institute for Biomedical Research, Salt Lake City, UT
Johns Hopkins University
University of Kansas
University of Minnesota - Clinical and Translational Science Institute
Mayo Clinic
University of Colorado, Aurora
University of New Mexico
University of Pennsylvania
Dartmouth Medical School, Lebanon, NH
National Multiple Sclerosis Society
Adeona Pharmaceuticals, Ann Arnor, MI
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00451204
First received: March 22, 2007
Last updated: January 23, 2012
Last verified: September 2010
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Purpose
This is a double-blinded, placebo controlled study of estriol pills versus placebo pills in relapsing remitting multiple sclerosis. The study treatment will be an added on to Copaxone injections in all subjects. The primary outcome measure is a reduction in relapses.
| Condition | Intervention | Phase |
|---|---|---|
|
Relapsing Remitting Multiple Sclerosis |
Drug: Estriol Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Combination Trial of Copaxone Plus Estriol in RRMS |
Resource links provided by NLM:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
U.S. FDA Resources
Further study details as provided by University of California, Los Angeles:
Primary Outcome Measures:
- Relapse Rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- severity of "Relapse" as assessed by degree of worsening of Expanded Disability Status Scale (EDSS) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- severity of "Relapse" as assessed by degree of worsening of Multiple Sclerosis Functional Composite (MSFC) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Proportion of subjects with confirmed progression in Expanded Disability Status Scale (EDSS) (at least 1.0 point for at least 6 months on two exams) between baseline and conclusion [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Expanded Disability Status Scale (EDSS) progression from baseline at conclusion [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Multiple Sclerosis Functional Composite (MSFC) progression from baseline at conclusion [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Improvement in Paced Serial Addition Test (PASAT) scores between baseline and conclusion [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Improvement in 7-24 Spatial Recall test scores between baseline and conclusion [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Improvement in Selective Reminding Test scores between baseline and conclusion [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Brain MRI enhancing lesions [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Brain atrophy on MRI [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 150 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Estriol Pills plus Copaxone injections
|
Drug: Estriol
Estriol 8 mg capsule, once per day, duration of treatment is 2 years
Other Names:
|
|
Placebo Comparator: 2
Placebo pills plus Copaxone injections
|
Drug: Placebo
Placebo capsule, once a day, treatment duration is 2 years
|
Detailed Description:
Multiple sclerosis (MS) relapses are known to be significantly decreased during pregnancy. This proposal will establish whether oral treatment with estriol, the major estrogen of pregnancy, induces a decrease in relapses in relapsing remitting multiple sclerosis (RRMS) subjects when used in combination with injectable Copaxone. Previously, in a pilot study, it has been demonstrated that treatment of RRMS subjects with oral estriol for six months resulted in a significant reduction in gadolinium enhancing lesions on serial brain MRIs (Annals of Neurology, 2002; 52:421-428) and caused a favorable shift in immune responses (Journal of Immunology, 2003; 171:6267-6274). This is an add-on study aiming to extend these previous findings by treating longer and focusing on clinical outcomes. The combination of Copaxone injection plus estriol pill (8 mg per day) will be compared to Copaxone injection plus placebo pill in a double blind trial. The duration of treatment will be two years and the primary outcome measure will be relapse rate. Secondary outcomes will include disability measures (MSFC, EDSS, Quality of Life, Fatigue and Depression testing) and a surrogate marker for disability (cerebral MRI for whole brain volume, gray matter atrophy and T1 holes). Safety measures (blood tests and gynecologic evaluations) will also be followed. The overall goal of this study will be the development of an oral anti-inflammatory treatment, estriol, for RRMS.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of relapsing remitting multiple sclerosis
- At least one relapse in the last two years
Exclusion Criteria:
- Patients treated in the past with total lymphoid irradiation, monoclonal antibody, T cell vaccination, cladribine, bone marrow transplantation, azathioprine, cyclophosphamide, methotrexate, mitoxantrone, cyclosporin or Tysabri
- Clinically significant diseases other than multiple sclerosis
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00451204
Locations
| United States, Arizona | |
| Mayo Clinic | |
| Scottsdale, Arizona, United States, 85259 | |
| United States, California | |
| University of California, Los Angeles | |
| Los Angeles, California, United States, 90095 | |
| United States, Colorado | |
| University of Colorado | |
| Aurora, Colorado, United States, 80045 | |
| United States, Illinois | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| United States, Kansas | |
| University of Kansas | |
| Kansas City, Kansas, United States, 66160 | |
| United States, Maryland | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21287-6965 | |
| United States, Minnesota | |
| University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Missouri | |
| Washington University | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, New Hampshire | |
| Dartmouth Medical School | |
| Lebanon, New Hampshire, United States, 03765 | |
| United States, New Jersey | |
| UMDNJ-Robert Wood Johnson Medical Center | |
| New Brunswick, New Jersey, United States, 08901 | |
| United States, New Mexico | |
| University of New Mexico | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, Ohio | |
| Ohio State University | |
| Columbus, Ohio, United States, 43221 | |
| United States, Pennsylvania | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Texas | |
| University of Texas Southwestern | |
| Dallas, Texas, United States, 75390-8575 | |
| United States, Utah | |
| Western Institute for Biomedical Research | |
| Salt Lake City, Utah, United States, 84158 | |
Sponsors and Collaborators
University of California, Los Angeles
Washington University School of Medicine
University of Texas Southwestern Medical Center
Ohio State University
University of Medicine and Dentistry New Jersey
University of Chicago
Western Institute for Biomedical Research, Salt Lake City, UT
Johns Hopkins University
University of Kansas
University of Minnesota - Clinical and Translational Science Institute
Mayo Clinic
University of Colorado, Aurora
University of New Mexico
University of Pennsylvania
Dartmouth Medical School, Lebanon, NH
National Multiple Sclerosis Society
Adeona Pharmaceuticals, Ann Arnor, MI
Investigators
| Study Director: | Rhonda Voskuhl, M.D. | University of California, Los Angeles (UCLA), Los Angeles, CA |
| Principal Investigator: | Anne Cross, M.D. | Washington University, Saint Louis, MO |
| Principal Investigator: | Ardith Courtney, D.O. | University of Texas, Southwestern, Dallas, TX |
| Principal Investigator: | Suhayl Dhib-Jalbut, M.D. | Robert Wood Johnson Medical School, UMDNJ, New Brunswick, NJ |
| Principal Investigator: | Michael Racke, M.D. | Ohio State University |
| Principal Investigator: | Anthony Reder, M.D. | University of Chicago |
| Principal Investigator: | John Rose, M.D. | Western Institute for Biomedical Research, Salt Lake City, UT |
| Principal Investigator: | Barbara Giesser, M.D. | University of California, Los Angeles (UCLA), Los Angeles, CA |
| Principal Investigator: | John Ratchford, M.D. | Johns Hopkins, Baltimore, MD |
| Principal Investigator: | Sharon Lynch, M.D. | University of Kansas |
| Principal Investigator: | Gareth Parry, M.D. | University of Minnesota - Clinical and Translational Science Institute |
| Principal Investigator: | Dean Wingerchuk, M.D. | Mayo Clinic |
| Principal Investigator: | John Corboy, M.D. | University of Colorado, Aurora |
| Principal Investigator: | Corey Ford, M.D. | University of New Mexico, Albuquerque |
| Principal Investigator: | Dina Jacobs, M.D. | University of Pennsylvania |
| Principal Investigator: | Enrico Lallana, M.D. | Dartmouth University, Lebanon, NH |
More Information
Additional Information:
Publications:
| Responsible Party: | Rhonda Voskuhl, M.D., University of California, Los Angeles |
| ClinicalTrials.gov Identifier: | NCT00451204 History of Changes |
| Other Study ID Numbers: | RO1-NS051591, NIH grant RO1-NS051591, NMSS grant RG 3915 |
| Study First Received: | March 22, 2007 |
| Last Updated: | January 23, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of California, Los Angeles:
|
Multiple sclerosis estrogen estriol progesterone |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Multiple Sclerosis, Relapsing-Remitting Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes |
Estrogens Copolymer 1 Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Adjuvants, Immunologic Immunologic Factors Immunosuppressive Agents |
ClinicalTrials.gov processed this record on May 16, 2013