Study to Assess Medication Satisfaction in Patients With Relapsing Remitting Multiple Sclerosis Treated With Copaxone®

What Was Tested

The trial (phase 4) is built around Glatiramer Acetate for multiple sclerosis.

It had two arms (groups): one (experimental) and one (active comparator).

The registry classes the interventions as drug.

Who Took Part

861 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Men or women at least 18 years of age or older. Patients must have a confirmed and documented RRMS diagnosis. Patients must be ambulatory with a Kurtzke EDSS score of 0 to 5.5 at screening visit. Patients must be in a stable neurological condition, relapse-free and free of any corticosteroid treatment 30 days prior to randomization. Women of child-bearing potential must have a negative urine pregnancy test at screening visit and must practice an acceptable method of birth.

The full record lists 7 inclusion and 11 exclusion criteria; among the exclusions: patient had any contraindication to copaxone therapy; patients with progressive forms of ms; patients with neuromyelitis optica.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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

Groups ran in parallel: each of the multiple sclerosis participants stayed in one arm throughout.

Being open-label, the Glatiramer Acetate study did not mask who received what.

It started in 2015-08-10 with completion listed for 2017-01-10.

It ran at 97 sites in United States (15), France (14), Poland (12), Russia (12), Italy (8) and Spain (7).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in the Medication Satisfaction Questionnaire (MSQ) to Month 6 Using a Repeated Measures ANCOVA (time frame: Baseline (Month 0), Months 1, 3 and 6).

It also tracked 5 secondary outcomes, for example Change From Baseline in the Modified Fatigue Impact Scale (MFIS) Total Score and Subscales to Month 6 Using a Repeated Measures ANCOVA, Change From Baseline in the Mental Health Index (MHI) Total Score and Subscales to Month 6 Using a Repeated Measures ANCOVA, Change From Baseline in the Beck Depression Inventory II (BDI-II) Total Score to Month 6 Using a Repeated Measures ANCOVA and Participants With Treatment-Emergent Adverse Events (TEAEs) During Both the Core Period and Extension Periods.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Glatiramer Acetate in 861 people with multiple sclerosis.

With 861 participants it is a large trial for this field.

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.