High Dose Cyclophosphamide Followed by Glatiramer Acetate in the Treatment of Relapsing Remitting Multiple Sclerosis

What Was Tested

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

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

The registry classes the interventions as drug.

More on the Plan

Multiple sclerosis (MS) is an autoimmune disease characterized by progressive immune-mediated destruction of myelin and axons within the CNS.

Despite the development, approval and clinical utilization of several medicines for patients with MS, most patients continue to accrue progressive disability.

Five out of 9 patients had recurrence of new brain MRI lesions during 24 months of follow-up, recurring in 4 patients during the first year of follow-up.

Glatiramer acetate was originally developed based on the observation that it inhibited the onset of clinical disease in an animal model of multiple sclerosis, experimental autoimmune encephalomyelitis (EAE).

Who Took Part

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Males and females between the ages of 18 and 70 years, inclusive. Diagnosis of clinically definite MS according to the McDonald Criteria. 2 or more total gadolinium enhancing lesions on each of two pretreatment MRI scans at screening and enrollment. Subject must have EDSS ranging from 1.5 to 6.5. Written informed consent prior to any testing under this protocol, including screening tests and evaluations that are not considered part of the subject's routine care.

The full record lists 9 inclusion and 9 exclusion criteria; among the exclusions: serum creatinine \> 2.0; patients who are pre-terminal or moribund; bilirubin \> 2.0, transaminases \> 2x normal.

How the Study Was Run

It was run as a single-group and open-label study.

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 2010-11 with completion listed for 2010-11.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Safety - Serious adverse events (time frame: 2 years).

It also tracked 3 secondary outcomes, for example Clinical/Neurological - Change in disability and Immunological - change in immune profile.

What This Means in Plain Language

Put simply, this is a phase 2 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.