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A Combination Trial of Copaxone Plus Estriol in Relapsing Remitting Multiple Sclerosis (RRMS) (Estriol-MS)

This study has been completed.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT00451204
First received: March 22, 2007
Last updated: May 10, 2016
Last verified: May 2016
History of Changes
Results First Received: January 20, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Relapsing Remitting Multiple Sclerosis
Interventions: Drug: Estriol
Drug: Placebo
Drug: Copaxone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Estriol Capsules Plus Copaxone Injections Estriol: Estriol 8 mg capsule, once per day, duration of treatment is 2 years
Placebo Capsules Plus Copaxone Injections Placebo: Placebo capsule, once per day, treatment duration is 2 years

Participant Flow:   Overall Study
    Estriol Capsules Plus Copaxone Injections     Placebo Capsules Plus Copaxone Injections  
STARTED     82     76  
COMPLETED     60 [1]   56  
NOT COMPLETED     22     20  
Adverse Event                 4                 6  
Lack of Efficacy                 4                 4  
Lost to Follow-up                 4                 4  
Protocol Violation                 1                 0  
Patient refusal                 8                 4  
Unknown                 1                 2  
[1] 60 completed the study but 3 stopped study drug(s) early



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Relapsing remitting multiple sclerosis women aged 18 to 50 years.

Reporting Groups
  Description
Estriol Capsules Plus Copaxone Injections Estriol: Estriol 8 mg capsule, once per day, duration of treatment is 2 years
Placebo Capsules Plus Copaxone Injections Placebo: Placebo capsule, once a day, treatment duration is 2 years
Total Total of all reporting groups

Baseline Measures
    Estriol Capsules Plus Copaxone Injections     Placebo Capsules Plus Copaxone Injections     Total  
Number of Participants  
[units: participants]
 		  82     76     158  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     82     76     158  
>=65 years     0     0     0  
Age  
[units: years]
Mean (Standard Deviation) 		  37.7  (7.6)     37.1  (7.3)     37.4  (7.45)  
Gender  
[units: participants]
 		     
Female     82     76     158  
Male     0     0     0  
Region of Enrollment  
[units: participants]
 		     
United States     82     76     158  



  Outcome Measures
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1.  Primary:   Confirmed Relapse, Annualized Relapse Rate   [ Time Frame: 24 months ]
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2.  Secondary:   Relapse Event, Annualized Relapse Rate   [ Time Frame: 24 months ]
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3.  Secondary:   Confirmed Relapse, Probability of First Relapse   [ Time Frame: 24 months ]
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4.  Secondary:   Relapse Event, Probability of First Relapse Event   [ Time Frame: 24 months ]
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5.  Other Pre-specified:   Confirmed Relapse, Annualized Relapse Rate   [ Time Frame: 12 months ]
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6.  Other Pre-specified:   Relapse Event, Annualized Relapse Rate   [ Time Frame: 12 months ]
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  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Rhonda Voskuhl
Organization: University of California Los Angeles
phone: 310-206-4636
e-mail: rvoskuhl@mednet.ucla.edu


Publications of Results:

Other Publications:


Responsible Party: Rhonda Voskuhl, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00451204     History of Changes
Other Study ID Numbers: R01NS051591 ( US NIH Grant/Contract Award Number )
RG3915 ( Other Grant/Funding Number: NMSS )
Study First Received: March 22, 2007
Results First Received: January 20, 2016
Last Updated: May 10, 2016
Health Authority: United States: Food and Drug Administration