Phase 2 Completed N=158 Randomized Triple-blind Treatment

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

Multiple Sclerosis

Source: ClinicalTrials.gov NCT00451204 ↗

Enrolled (actual)

158

Serious AEs

11.4%

Results posted

Jun 2016

Primary outcomePrimary: Confirmed Relapse, Annualized Relapse Rate — 0.25; 0.37 relapses per year — p=0.077

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Confirmed Relapse, Annualized Relapse Rate	0.25; 0.48	0.016 sig
SECONDARY Relapse Event, Annualized Relapse Rate	0.33; 0.61	0.012 sig
SECONDARY Confirmed Relapse, Probability of First Relapse	33.3; 42.9	0.096
SECONDARY Relapse Event, Probability of First Relapse Event	40.5; 46.9	0.179

Eligibility 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

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Data sourced from ClinicalTrials.gov (NCT00451204). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.