View Clinical Trial (Medical Research Study)
A Combination Trial of Copaxone Plus Estriol in Relapsing Remitting Multiple Sclerosis (RRMS) - NCT00451204-63110(Clinical Trial 166388)
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| City: |
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Saint Louis |
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State:
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MO |
| Zip Code: |
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63110 |
| Conditions: |
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Relapsing Remitting Multiple Sclerosis |
| Purpose: |
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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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| Study summary: |
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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 outcomes will include disability
measures (MSFC, EDSS, Quality of Life, Fatigue and Depression testing) and a surrogate
marker for disability (cerebral MRI for whole brain volume, gray matter atrophy and T1
holes). 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. |
| Criteria: |
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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 |
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| Study is available at: |
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Washington University
Saint Louis, MO 63110
United States
Primary Contact:
Debbie Kemp, R.N.
Email: kempd@wusm.wustl.edu
Phone: 314-362-3839
Secondary Contact:
Mike Montag
Email: MMontag@mednet.ucla.edu
Phone: (310)794-4020 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 22, 2011 |
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