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Sponsors and Collaborators: |
University of California, Los Angeles Washington University School of Medicine, Saint Louis, MO University of Texas Southwestern Medical Center Ohio State University University of Medicine and Dentistry New Jersey University of Chicago VA Salt Lake City Health Care System National Multiple Sclerosis Society National Institutes of Health (NIH) Pipex Pharmaceuticals, Ann Arnor, MI |
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Information provided by: | University of California, Los Angeles |
ClinicalTrials.gov Identifier: | NCT00451204 |
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 |
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Relapsing Remitting Multiple Sclerosis |
Drug: Estriol Drug: Placebo |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Combination Trial of Copaxone Plus Estriol in RRMS |
Estimated Enrollment: | 150 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | July 2011 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Estriol Pills plus Copaxone injections
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Drug: Estriol
Estriol 8 mg capsule, once per day, duration of treatment is 2 years
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2: Placebo Comparator
Placebo pills plus Copaxone injections
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Drug: Placebo
Placebo capsule, once a day, treatment duration is 2 years
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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.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sofia Quesada | (310)825-7313 | squezada@mednet.ucla.edu |
Contact: Mike Montag | (310)825-7313 | MMontag@mednet.ucla.edu |
United States, California | |
University of California, Los Angeles | Recruiting |
Los Angeles, California, United States, 90095 | |
Contact: Sofia Quesada 310-825-7313 squezada@mednet.ucla.edu | |
Contact: Mike Montag (310)825-7313 MMontag@mednet.ucla.edu | |
Principal Investigator: Rhonda Voskuhl, M.D. | |
Sub-Investigator: Barbara Giesser, M.D. | |
Sub-Investigator: Nancy Sicotte, M.D. | |
Sub-Investigator: T.C. Jackson Wu, M.D., Ph.D. | |
Sub-Investigator: Robert Elashoff, Ph.D. | |
United States, Illinois | |
University of Chicago | Recruiting |
Chicago, Illinois, United States, 60637 | |
Contact: Mildred Valentine 773-702-9812 mvalenti@neurology.bsd.uchicago.edu | |
Contact: Krystal Ivy (773)834-4654 kivy@neurology.bsd.uchicago.edu | |
Principal Investigator: Anthony Reder, M.D. | |
United States, Missouri | |
Washington University | Recruiting |
Saint Louis, Missouri, United States, 63110 | |
Contact: Terri Radake, R.N. 314-747-1761 Radaket@msnotes.com | |
Contact: Monica Fairburn (314)747-5576 | |
Principal Investigator: Anne Cross, M.D. | |
United States, New Jersey | |
UMDNJ-Robert Wood Johnson Medical Center | Recruiting |
New Brunswick, New Jersey, United States, 08901 | |
Contact: Yaritza Rosario 732-235-7099 rosariym@umdnj.edu | |
Principal Investigator: Suhayl Dhib-Jalbut, M.D. | |
United States, Ohio | |
Ohio State University | Recruiting |
Columbus, Ohio, United States, 43221 | |
Contact: Lisa Hafer 614-293-7877 Lisa.hafer@osumc.edu | |
Principal Investigator: Deborah J. Lynn, M.D. | |
United States, Texas | |
University of Texas Southwestern | Recruiting |
Dallas, Texas, United States, 75390-8575 | |
Contact: Gina Remington 214-645-0560 Gina.Remington@UTSouthwestern.edu | |
Contact: Gina Remington (214)786-0275 | |
Principal Investigator: Elliot Frohman, M.D. | |
United States, Utah | |
Salt Lake Cuty VA Medical Center | Recruiting |
Salt Lake City, Utah, United States, 84158 | |
Contact: Julia Klein 801-582-1565 ext 2014 Julia.klein@va.gov | |
Contact: Julia Klein (801)232-2109 | |
Principal Investigator: John Rose, M.D. |
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: | Elliot Frohman, M.D. | University of Texas, Southwestern, Dallas, TX |
Principal Investigator: | Suhayl Dhib-Jalbut, M.D. | Robert Wood Johnson Medical School, UMDNJ, New Brunswick, NJ |
Principal Investigator: | Deborah J Lynn, M.D. | Ohio State University, Columbus, OH |
Principal Investigator: | Anthony Reder, M.D. | University of Chicago |
Principal Investigator: | John Rose, M.D. | VA Salt Lake City Health Care System |
Principal Investigator: | Barbara Giesser, M.D. | University of California, Los Angeles (UCLA), Los Angeles, CA |
Responsible Party: | University of California, Los Angeles ( Rhonda Voskuhl, M.D. ) |
Study ID Numbers: | RO1-NS051591, NIH grant RO1-NS051591, NMSS grant RG 3915 |
Study First Received: | March 22, 2007 |
Last Updated: | March 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00451204 |
Health Authority: | United States: Food and Drug Administration |
Multiple sclerosis estrogen estriol progesterone |
Copolymer 1 Autoimmune Diseases Multiple Sclerosis Progesterone Demyelinating Diseases |
Demyelinating Autoimmune Diseases, CNS Demyelinating diseases Sclerosis Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases of the Nervous System |
Pathologic Processes Immune System Diseases Nervous System Diseases |