Trial record 1 of 2 for:
estriol AND multiple sclerosis
A Combination Trial of Copaxone Plus Estriol in Relapsing Remitting Multiple Sclerosis (RRMS) (Estriol-MS)
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ClinicalTrials.gov Identifier: NCT00451204 |
Recruitment Status
:
Completed
First Posted
: March 23, 2007
Results First Posted
: June 16, 2016
Last Update Posted
: June 16, 2016
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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 of New Jersey
University of Chicago
University of Utah
Johns Hopkins University
University of Kansas Medical Center
University of Minnesota, MN
Mayo Clinic
University of Colorado, Aurora
University of New Mexico
University of Pennsylvania
Dartmouth-Hitchcock Medical Center
National Multiple Sclerosis Society
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Rhonda Voskuhl, University of California, Los Angeles
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First Submitted Date ICMJE | March 22, 2007 | ||||||||||||||||||||||||||||||||||||||||||||||||
First Posted Date ICMJE | March 23, 2007 | ||||||||||||||||||||||||||||||||||||||||||||||||
Results First Submitted Date | January 20, 2016 | ||||||||||||||||||||||||||||||||||||||||||||||||
Results First Posted Date | June 16, 2016 | ||||||||||||||||||||||||||||||||||||||||||||||||
Last Update Posted Date | June 16, 2016 | ||||||||||||||||||||||||||||||||||||||||||||||||
Study Start Date ICMJE | March 2007 | ||||||||||||||||||||||||||||||||||||||||||||||||
Actual Primary Completion Date | July 2014 (Final data collection date for primary outcome measure) | ||||||||||||||||||||||||||||||||||||||||||||||||
Current Primary Outcome Measures ICMJE |
Confirmed Relapse, Annualized Relapse Rate [ Time Frame: 24 months ] A confirmed relapse was defined as new neurological symptoms or worsening of pre-existing symptoms, lasting at least 48 hours in a subject who had been neurologically stable or improving in the previous 30 days, accompanied by objective change in the neurological examination (worsening of 0.5 points on the EDSS or worsening by 1.0 or more points on the pyramidal, cerebellar, brainstem or visual functional system scores), not due to fatigue alone and not associated with fever or infection.
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Original Primary Outcome Measures ICMJE |
Relapse Rate | ||||||||||||||||||||||||||||||||||||||||||||||||
Change History | Complete list of historical versions of study NCT00451204 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||||||||||||||||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE |
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Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||||||||||||||||||||||||||
Descriptive Information | |||||||||||||||||||||||||||||||||||||||||||||||||
Brief Title ICMJE | A Combination Trial of Copaxone Plus Estriol in Relapsing Remitting Multiple Sclerosis (RRMS) | ||||||||||||||||||||||||||||||||||||||||||||||||
Official Title ICMJE | A Combination Trial of Copaxone Plus Estriol in RRMS | ||||||||||||||||||||||||||||||||||||||||||||||||
Brief Summary | 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. | ||||||||||||||||||||||||||||||||||||||||||||||||
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. Other outcomes will include disability measures and brain MRI outcomes. Safety measures (blood tests and gynecologic evaluations) will also be followed and correlations will be made between serum estriol levels with efficacy and safety. The overall goal of this study will be the development of a new oral treatment, estriol, for RRMS. | ||||||||||||||||||||||||||||||||||||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||||||||||||||||||||||||||||||||||||
Study Phase | Phase 2 | ||||||||||||||||||||||||||||||||||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Relapsing Remitting Multiple Sclerosis | ||||||||||||||||||||||||||||||||||||||||||||||||
Intervention ICMJE |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||||||||||||||||||||||||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||||||||||||||||||||||||||||||||||||||
Actual Enrollment ICMJE |
158 | ||||||||||||||||||||||||||||||||||||||||||||||||
Original Enrollment ICMJE |
150 | ||||||||||||||||||||||||||||||||||||||||||||||||
Actual Study Completion Date | July 2014 | ||||||||||||||||||||||||||||||||||||||||||||||||
Actual Primary Completion Date | July 2014 (Final data collection date for primary outcome measure) | ||||||||||||||||||||||||||||||||||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 50 Years (Adult) | ||||||||||||||||||||||||||||||||||||||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||||||||||||||||||||||||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||||||||||||||||||||||||||||||
Listed Location Countries ICMJE | Canada, United States | ||||||||||||||||||||||||||||||||||||||||||||||||
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Administrative Information | |||||||||||||||||||||||||||||||||||||||||||||||||
NCT Number ICMJE | NCT00451204 | ||||||||||||||||||||||||||||||||||||||||||||||||
Other Study ID Numbers ICMJE | R01NS051591( U.S. NIH Grant/Contract ) R01NS051591 ( U.S. NIH Grant/Contract ) RG3915 ( Other Grant/Funding Number: NMSS ) |
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Has Data Monitoring Committee | Yes | ||||||||||||||||||||||||||||||||||||||||||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||||||||||||||||||||||||||||||||||||||||||
IPD Sharing Statement |
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Responsible Party | Rhonda Voskuhl, University of California, Los Angeles | ||||||||||||||||||||||||||||||||||||||||||||||||
Study Sponsor ICMJE | University of California, Los Angeles | ||||||||||||||||||||||||||||||||||||||||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | University of California, Los Angeles | ||||||||||||||||||||||||||||||||||||||||||||||||
Verification Date | May 2016 | ||||||||||||||||||||||||||||||||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |