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

What Was Tested

This registered phase 2 trial tested Glatiramer Acetate for multiple sclerosis.

The study treatment will be an added on to Copaxone injections in all subjects.

It had two arms (groups): Estriol plus Copaxone injections QD (active comparator) and Placebo plus Copaxone injections QD (placebo comparator).

Estriol Capsules (daily) plus Copaxone injections (daily). Progestin capsules given for 2 weeks every 3 months to avoid unopposed estrogens.

Placebo Capsules (daily) plus Copaxone injections (daily). A second placebo capsule given for 2 weeks every 3 months.

The registry classes the interventions as drug.

More on the Plan

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.

The overall goal of this study will be the development of a new oral treatment, estriol, for RRMS.

Who Took Part

The registry lists 158 actual participants took part.

It was open to women only aged from 18 years up to 50 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: At least one relapse in the last two years.

The full record lists 2 inclusion and 2 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

The multiple sclerosis participants were allocated by chance, so the Glatiramer Acetate group and the comparison group should start out alike.

The Glatiramer Acetate group and the comparison group ran side by side rather than switching.

As a double-blind Glatiramer Acetate study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2007-03 with completion listed for 2014-07.

It ran at 16 sites in United States (15) and Canada (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Confirmed Relapse, Annualized Relapse Rate (time frame: 24 months).

It also tracked 3 secondary outcomes, for example Relapse Event, Annualized Relapse Rate, Confirmed Relapse, Probability of First Relapse and Relapse Event, Probability of First Relapse Event.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Glatiramer Acetate in 158 people with multiple sclerosis.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Glatiramer Acetate compound page, Multiple sclerosis research.