Efficacy, Safety, and Tolerability of Plovamer Acetate (Pathway 1)

What Was Tested

The trial (phase 2) is built around Glatiramer Acetate for multiple sclerosis.

The trial will be conducted on an outpatient basis for minimum treatment duration of 40 weeks.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 255 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Male or female, between the ages of 18 and 60 years. Subject is able to learn and self-administer subcutaneous injections (a care-giver may be trained to inject the subject). Subjects must have a current diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS) (according to the 2010 McDonald MS diagnostic criteria). Other protocol defined inclusion criteria could apply.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: any multiple sclerosis categorized as primary progressive, secondary progressive or progressive relapsing; allergy to mannitol, plovamer acetate, copaxone (glatiramer acetate), gd contrast for mri; contraindication to copaxone use.

How the Study Was Run

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

Because people in this Glatiramer Acetate study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

In this single-blind Glatiramer Acetate study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2013-10 with completion listed for 2015-03.

It ran at 118 sites in United States (35), Russia (10), Italy (8), Mexico (7), Poland (7) and Ukraine (7).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan (time frame: Baseline , Week 12, 24, 28, 32, 36, 40).

It also tracked 9 secondary outcomes, for example Mean Annualized Relapse Rate (ARR), Percentage of Subjects Remaining Relapse-Free, Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan, Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan, Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan and Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Glatiramer Acetate in 255 people with multiple sclerosis.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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