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NCT Number: NCT00451204

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

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.

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Key information

Conditions

Relapsing Remitting Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Montreal Neurological Institute, Montreal, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

estriol

Drug

Estriol 8 mg capsule, once per day, duration of treatment is 2 years

Other names: E3, estrogen

Placebo

Drug

Placebo capsule, once a day, treatment duration is 2 years

Other names: "sugar pill"

Copaxone

Drug

Injection, once a day, all subjects

Other names: glatiramer acetate

Primary outcomes

  1. 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.

Secondary outcomes

  1. Relapse Event, Annualized Relapse Rate

    Time frame: 24 months

    Met all criteria for relapse except not confirmed to have increase in EDSS by an independent examiner.

  2. Confirmed Relapse, Probability of First Relapse

    Time frame: 24 months

  3. Relapse Event, Probability of First Relapse Event

    Time frame: 24 months

Other outcomes

  1. Confirmed Relapse, Annualized Relapse Rate

    Time frame: 12 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.

  2. Relapse Event, Annualized Relapse Rate

    Time frame: 12 months

    Met all criteria for relapse except not confirmed to have increase in EDSS by an independent examiner.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Dartmouth-Hitchcock Medical Center
  • Johns Hopkins University
  • Mayo Clinic
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • National Institutes of Health (NIH)
  • National Multiple Sclerosis Society
  • Ohio State University
  • University of Chicago
  • University of Colorado, Denver
  • University of Kansas Medical Center
  • University of Medicine and Dentistry of New Jersey
  • University of Minnesota
  • University of New Mexico
  • University of Pennsylvania
  • University of Texas Southwestern Medical Center
  • University of Utah
  • Washington University School of Medicine

Registry information

Official study title

A Combination Trial of Copaxone Plus Estriol in RRMS

Acronym: Estriol-MS

Important dates

Study start
2007
Primary completion
2014
Study completion
2014
First posted
Mar 23, 2007
Registry last updated
Jun 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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