A Combination Trial of Copaxone Plus Estriol in Relapsing Remitting Multiple Sclerosis (RRMS)
NCT ID: NCT00451204
Last Updated: 2016-06-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
158 participants
INTERVENTIONAL
2007-03-31
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Estriol plus Copaxone injections QD
Estriol Capsules (daily) plus Copaxone injections (daily). Progestin capsules given for 2 weeks every 3 months to avoid unopposed estrogens.
Estriol
Estriol 8 mg capsule, once per day, duration of treatment is 2 years
Copaxone
Injection, once a day, all subjects
Placebo plus Copaxone injections QD
Placebo Capsules (daily) plus Copaxone injections (daily). A second placebo capsule given for 2 weeks every 3 months.
Placebo
Placebo capsule, once a day, treatment duration is 2 years
Copaxone
Injection, once a day, all subjects
Interventions
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Estriol
Estriol 8 mg capsule, once per day, duration of treatment is 2 years
Placebo
Placebo capsule, once a day, treatment duration is 2 years
Copaxone
Injection, once a day, all subjects
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least one relapse in the last two years
Exclusion Criteria
* Clinically significant diseases other than multiple sclerosis
18 Years
50 Years
FEMALE
No
Sponsors
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Washington University School of Medicine
OTHER
University of Texas Southwestern Medical Center
OTHER
Ohio State University
OTHER
University of Medicine and Dentistry of New Jersey
OTHER
University of Chicago
OTHER
University of Utah
OTHER
Johns Hopkins University
OTHER
University of Kansas Medical Center
OTHER
University of Minnesota
OTHER
Mayo Clinic
OTHER
University of Colorado, Denver
OTHER
University of New Mexico
OTHER
University of Pennsylvania
OTHER
Dartmouth-Hitchcock Medical Center
OTHER
National Multiple Sclerosis Society
OTHER
National Institutes of Health (NIH)
NIH
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
University of California, Los Angeles
OTHER
Responsible Party
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Rhonda Voskuhl
Professor, Department of Neurology; Director Multiple Sclerosis Program
Principal Investigators
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Rhonda Voskuhl, M.D.
Role: STUDY_DIRECTOR
University of California, Los Angeles (UCLA), Los Angeles, CA
Anne Cross, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University, Saint Louis, MO
Elliot Frohman, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Texas, Southwestern, Dallas, TX
Suhayl Dhib-Jalbut, M.D.
Role: PRINCIPAL_INVESTIGATOR
Robert Wood Johnson Medical School, UMDNJ, New Brunswick, NJ
Michael Racke, M.D.
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Anthony Reder, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
John Rose, M.D.
Role: PRINCIPAL_INVESTIGATOR
Western Institute for Biomedical Research, Salt Lake City, UT
Barbara Giesser, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles (UCLA), Los Angeles, CA
John Ratchford, M.D.
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins, Baltimore, MD
Sharon Lynch, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Kansas
Gareth Parry, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Dean Wingerchuk, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
John Corboy, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Corey Ford, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of New Mexico, Albuquerque
Dina Jacobs, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Lloyd Kasper, M.D.
Role: PRINCIPAL_INVESTIGATOR
Dartmouth University, Lebanon, NH
Locations
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Mayo Clinic
Scottsdale, Arizona, United States
University of California, Los Angeles
Los Angeles, California, United States
University of Colorado
Aurora, Colorado, United States
University of Chicago
Chicago, Illinois, United States
University of Kansas
Kansas City, Kansas, United States
Johns Hopkins University
Baltimore, Maryland, United States
University of Minnesota
Minneapolis, Minnesota, United States
Washington University
St Louis, Missouri, United States
Dartmouth Medical School
Lebanon, New Hampshire, United States
UMDNJ-Robert Wood Johnson Medical Center
New Brunswick, New Jersey, United States
University of New Mexico
Albuquerque, New Mexico, United States
Ohio State University
Columbus, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Texas Southwestern
Dallas, Texas, United States
Western Institute for Biomedical Research
Salt Lake City, Utah, United States
Montreal Neurological Institute
Montreal, , Canada
Countries
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References
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Sicotte NL, Liva SM, Klutch R, Pfeiffer P, Bouvier S, Odesa S, Wu TC, Voskuhl RR. Treatment of multiple sclerosis with the pregnancy hormone estriol. Ann Neurol. 2002 Oct;52(4):421-8. doi: 10.1002/ana.10301.
Soldan SS, Alvarez Retuerto AI, Sicotte NL, Voskuhl RR. Immune modulation in multiple sclerosis patients treated with the pregnancy hormone estriol. J Immunol. 2003 Dec 1;171(11):6267-74. doi: 10.4049/jimmunol.171.11.6267.
Morales LB, Loo KK, Liu HB, Peterson C, Tiwari-Woodruff S, Voskuhl RR. Treatment with an estrogen receptor alpha ligand is neuroprotective in experimental autoimmune encephalomyelitis. J Neurosci. 2006 Jun 21;26(25):6823-33. doi: 10.1523/JNEUROSCI.0453-06.2006.
Tiwari-Woodruff S, Morales LB, Lee R, Voskuhl RR. Differential neuroprotective and antiinflammatory effects of estrogen receptor (ER)alpha and ERbeta ligand treatment. Proc Natl Acad Sci U S A. 2007 Sep 11;104(37):14813-8. doi: 10.1073/pnas.0703783104. Epub 2007 Sep 4.
Sicotte NL, Giesser BS, Tandon V, Klutch R, Steiner B, Drain AE, Shattuck DW, Hull L, Wang HJ, Elashoff RM, Swerdloff RS, Voskuhl RR. Testosterone treatment in multiple sclerosis: a pilot study. Arch Neurol. 2007 May;64(5):683-8. doi: 10.1001/archneur.64.5.683.
Gold SM, Sasidhar MV, Morales LB, Du S, Sicotte NL, Tiwari-Woodruff SK, Voskuhl RR. Estrogen treatment decreases matrix metalloproteinase (MMP)-9 in autoimmune demyelinating disease through estrogen receptor alpha (ERalpha). Lab Invest. 2009 Oct;89(10):1076-83. doi: 10.1038/labinvest.2009.79. Epub 2009 Aug 10.
Ziehn MO, Avedisian AA, Dervin SM, O'Dell TJ, Voskuhl RR. Estriol preserves synaptic transmission in the hippocampus during autoimmune demyelinating disease. Lab Invest. 2012 Aug;92(8):1234-45. doi: 10.1038/labinvest.2012.76. Epub 2012 Apr 23.
Spence RD, Hamby ME, Umeda E, Itoh N, Du S, Wisdom AJ, Cao Y, Bondar G, Lam J, Ao Y, Sandoval F, Suriany S, Sofroniew MV, Voskuhl RR. Neuroprotection mediated through estrogen receptor-alpha in astrocytes. Proc Natl Acad Sci U S A. 2011 May 24;108(21):8867-72. doi: 10.1073/pnas.1103833108. Epub 2011 May 9.
Voskuhl RR, Wang H, Wu TC, Sicotte NL, Nakamura K, Kurth F, Itoh N, Bardens J, Bernard JT, Corboy JR, Cross AH, Dhib-Jalbut S, Ford CC, Frohman EM, Giesser B, Jacobs D, Kasper LH, Lynch S, Parry G, Racke MK, Reder AT, Rose J, Wingerchuk DM, MacKenzie-Graham AJ, Arnold DL, Tseng CH, Elashoff R. Estriol combined with glatiramer acetate for women with relapsing-remitting multiple sclerosis: a randomised, placebo-controlled, phase 2 trial. Lancet Neurol. 2016 Jan;15(1):35-46. doi: 10.1016/S1474-4422(15)00322-1. Epub 2015 Nov 29.
Other Identifiers
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