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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
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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Relapsing Remitting Multiple Sclerosis
Interventions: Drug: Estriol
Drug: Placebo
Drug: Copaxone

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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 
Other                1                2 
[1] 60 completed the study but 3 stopped study drug(s) early



  Baseline Characteristics

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 
Overall Participants Analyzed 
[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

1.  Primary:   Confirmed Relapse, Annualized Relapse Rate   [ Time Frame: 24 months ]
  Show Outcome Measure 1

2.  Secondary:   Relapse Event, Annualized Relapse Rate   [ Time Frame: 24 months ]
  Show Outcome Measure 2

3.  Secondary:   Confirmed Relapse, Probability of First Relapse   [ Time Frame: 24 months ]
  Show Outcome Measure 3

4.  Secondary:   Relapse Event, Probability of First Relapse Event   [ Time Frame: 24 months ]
  Show Outcome Measure 4

5.  Other Pre-specified:   Confirmed Relapse, Annualized Relapse Rate   [ Time Frame: 12 months ]
  Show Outcome Measure 5

6.  Other Pre-specified:   Relapse Event, Annualized Relapse Rate   [ Time Frame: 12 months ]
  Show Outcome Measure 6


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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 ( U.S. NIH Grant/Contract )
RG3915 ( Other Grant/Funding Number: NMSS )
First Submitted: March 22, 2007
First Posted: March 23, 2007
Results First Submitted: January 20, 2016
Results First Posted: June 16, 2016
Last Update Posted: June 16, 2016