A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMT

What Was Tested

The trial (phase 3) is built around Glatiramer Acetate for multiple sclerosis.

It had 1 arm (groups): Alemtuzumab (experimental).

The registry classes the interventions as drug.

More on the Plan

The duration of study per participant was approximately 5 years and 5 months.

Who Took Part

16 actual participants took part.

It was open to people of any sex aged from 10 years up to 18 years.

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

Examples of who could join: Signed written informed consent/assent obtained from participant and participant's legal representative (parent or guardian) according to local regulations. Expanded Disability Status Scale (EDSS) score of 0.0 to 5.0 (inclusive) at screening. At least 1 of the following:. \>=1 new or enlarging T2 hyperintense lesion or gadolinium enhancing lesion while on that same prior therapy (IFNB or GA), or. Two or more relapses in the prior year, or.

The full record lists 8 inclusion and 32 exclusion criteria; among the exclusions: any progressive or non-relapsing forms of ms; conditions/situations such as:; impossibility to meet specific protocol requirements.

How the Study Was Run

Design: single-group and open-label.

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2017-10-23 with completion listed for 2021-05-04.

It ran at 13 sites in Russia (4), France (2), Italy (2), Poland (2), Turkey (Türkiye) (2) and United Kingdom (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Brain Magnetic Resonance Imaging (MRI) Assessment: Adjusted Number of New or Enlarged T2 Lesions Per Month (time frame: Period 1: Month -4 up to Month 0, Period 2: Month up 4 to Month 8).

It also tracked 18 secondary outcomes, for example Brain Magnetic Resonance Imaging Assessment: Number of Participants With New or Enlarged T2 Lesions, Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Months 4 and 8, Adjusted Annualized Relapse Rate (ARR) at Year 2, Change From Baseline in Cognition Test Score of Brief Visuospatial Memory Test - Revised (BVMT-R) Total Score, Change From Baseline in Pediatric Quality of Life (PedsQL) Questionnaire Score and Change From Baseline in Pediatric Quality of Life in Neurological Disorders (NeuroQoL) Questionnaire Score.

What This Means in Plain Language

Put simply, this is a phase 3 trial of Glatiramer Acetate in 16 people with multiple sclerosis.

Its size is small, so on its own it can only give an early look.

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.