A Multinational, Randomized, Double-blind, Parallel-group, Placebo-controlled Study Assessing the Safety and Tolerability

What Was Tested

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

It had three arms (groups): Laquinimod 0.6 (experimental), Laquinimod 1.2 (experimental) and GA or IFN + Placebo (experimental).

The registry classes the interventions as drug and other.

Who Took Part

It was open to people of any sex aged from 18 years up to 55 years.

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

Examples of who could join: Subjects must have a documented MS diagnosis as defined by the Revised McDonald criteria \[Ann Neurol 2011: 69:292-302\], with a relapsing-remitting disease course. Subjects must be ambulatory with an EDSS score of 1-5.5 (inclusive) at the baseline visit. Subjects must be relapse-free and in a stable neurological condition and free of corticosteroid treatment \[intravenous (IV), intramuscular (IM) and/or oral\] 30 days prior to screening (month -1). Subjects must have had experienced at least one documented relapse in the 36 weeks prior to randomization, with an incomplete recovery of the neurological functions as compared to pre-relapse status. Subjects must be between 18 and 55 years of age, inclusive.

The full record lists 9 inclusion and 30 exclusion criteria; among the exclusions: use of experimental or investigational drugs, and/or participation in drug clinical studies within the 6 months prior to screening; use of immunosuppressive including mitoxantrone (novantrone®) or cytotoxic agents within 6 months prior to the screening visit; previous use of either of the following: natalizumab (tysabri®), cladribine, laquinimod, and fingolimod (gilenya®).

How the Study Was Run

Design: randomized, parallel-group and double-blind.

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.

Neither the multiple sclerosis participants nor the staff measuring them knew who was on Glatiramer Acetate, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2012-03 with completion listed for 2013-12.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example Tolerability.

What This Means in Plain Language

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

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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