Trial record 2 of 2 for:    estriol ms

A Combination Trial of Copaxone Plus Estriol in Relapsing Remitting Multiple Sclerosis (RRMS) (Estriol in 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
Western Institute for Biomedical Research, Salt Lake City, UT
Johns Hopkins University
University of Kansas
University of Minnesota - Clinical and Translational Science Institute
Mayo Clinic
University of Colorado, Aurora
University of New Mexico
University of Pennsylvania
Dartmouth Medical School, Lebanon, NH
National Multiple Sclerosis Society
Synthetic Biologics, Ann Arnor, MI
Information provided by (Responsible Party):
Rhonda Voskuhl, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00451204
First received: March 22, 2007
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

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
Relapsing Remitting Multiple Sclerosis
Drug: Estriol
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Combination Trial of Copaxone Plus Estriol in RRMS

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Relapse Rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • severity of "Relapse" as assessed by degree of worsening of Expanded Disability Status Scale (EDSS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Proportion of subjects with confirmed progression in Expanded Disability Status Scale (EDSS) (at least 1.0 point for at least 6 months on two exams) between baseline and conclusion [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Expanded Disability Status Scale (EDSS) progression from baseline at conclusion [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Improvement in Paced Serial Addition Test (PASAT) scores between baseline and conclusion [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Improvement in 7-24 Spatial Recall test scores between baseline and conclusion [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Improvement in Selective Reminding Test scores between baseline and conclusion [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Brain MRI enhancing lesions [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Time to first relapse [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The number of days to relapse from month 0 will be assessed in each treatment group


Enrollment: 158
Study Start Date: March 2007
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Estriol Pills plus Copaxone injections
Drug: Estriol
Estriol 8 mg capsule, once per day, duration of treatment is 2 years
Other Names:
  • E3
  • estrogen
Placebo Comparator: 2
Placebo pills plus Copaxone injections
Drug: Placebo
Placebo capsule, once a day, treatment duration is 2 years

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. Secondary and exploratory outcomes will include disability measures (MSFC, EDSS, Quality of Life, Fatigue and Depression testing) and MRI as a biomarker (white matter enhancing lesion number and volume, T2 lesion volume). 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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of relapsing remitting multiple sclerosis
  • At least one relapse in the last two years

Exclusion Criteria:

  • Patients treated in the past with total lymphoid irradiation, monoclonal antibody, T cell vaccination, cladribine, bone marrow transplantation, azathioprine, cyclophosphamide, methotrexate, mitoxantrone, cyclosporin or Tysabri
  • Clinically significant diseases other than multiple sclerosis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00451204

Locations
United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259
United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Kansas
University of Kansas
Kansas City, Kansas, United States, 66160
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287-6965
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
United States, New Hampshire
Dartmouth Medical School
Lebanon, New Hampshire, United States, 03765
United States, New Jersey
UMDNJ-Robert Wood Johnson Medical Center
New Brunswick, New Jersey, United States, 08901
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43221
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
University of Texas Southwestern
Dallas, Texas, United States, 75390-8575
United States, Utah
Western Institute for Biomedical Research
Salt Lake City, Utah, United States, 84158
Sponsors and Collaborators
University of California, Los Angeles
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
Western Institute for Biomedical Research, Salt Lake City, UT
Johns Hopkins University
University of Kansas
University of Minnesota - Clinical and Translational Science Institute
Mayo Clinic
University of Colorado, Aurora
University of New Mexico
University of Pennsylvania
Dartmouth Medical School, Lebanon, NH
National Multiple Sclerosis Society
Synthetic Biologics, Ann Arnor, MI
Investigators
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: Angela Bates, 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: Michael Racke, M.D. Ohio State University
Principal Investigator: Anthony Reder, M.D. University of Chicago
Principal Investigator: John Rose, M.D. Western Institute for Biomedical Research, Salt Lake City, UT
Principal Investigator: Barbara Giesser, M.D. University of California, Los Angeles (UCLA), Los Angeles, CA
Principal Investigator: John Ratchford, M.D. Johns Hopkins, Baltimore, MD
Principal Investigator: Sharon Lynch, M.D. University of Kansas
Principal Investigator: Gareth Parry, M.D. University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Dean Wingerchuk, M.D. Mayo Clinic
Principal Investigator: John Corboy, M.D. University of Colorado, Aurora
Principal Investigator: Corey Ford, M.D. University of New Mexico, Albuquerque
Principal Investigator: Dina Jacobs, M.D. University of Pennsylvania
Principal Investigator: Enrico Lallana, M.D. Dartmouth University, Lebanon, NH
  More Information

Publications:

Responsible Party: Rhonda Voskuhl, Professor, Department of Neurology; Director Multiple Sclerosis Program, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00451204     History of Changes
Other Study ID Numbers: RO1-NS051591, NIH grant RO1-NS051591, NMSS grant RG 3915
Study First Received: March 22, 2007
Last Updated: May 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, Los Angeles:
Multiple sclerosis
estrogen
estriol
progesterone

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014