Six ALS Clinical Trials: Rasagiline

by Amy Madsen on Wed, 2013-05-01 09:23

Name: Rasagiline. This drug is approved by the U.S. Food and Drug Administration for the treatment of Parkinson’s disease; it is marketed under the brand name Azilect.

How it works: Rasagiline, which belongs to a class of drugs called monoamine oxidase B inhibitors, has demonstrated neuroprotective properties in cell culture studies and in the SOD1 research mouse model of ALS.

Ball-and-stick model of the rasagiline (Azilect) molecule (courtesy of Teva Pharmaceutical Industries).

Purpose of trial: To determine if rasagiline is safe and if it slows disease progression in people with ALS.

Type of trial: Rasagiline currently is being tested in people with ALS in two separate ongoing phase 2 trials.

Trial sites:

  1. One trial is being conducted at the University of Kansas Medical Center, Kansas City.
  2. The other trial has sites in Arizona, California, Iowa, Kansas, Minnesota, Nebraska, Pennsylvania, Tennessee, Texas and Canada.

Outcome measures:

  1. The primary outcome measure in both trials is change in the rate of decline of function, as measured by the ALSFRS-R (ALS Functional Rating Scale-Revised).
  2. Secondary outcome measures in the University of Kansas study include changes in breathing function and in quality of life; adverse events; and differences in survival between those taking rasagiline and those taking placebo. Investigators also will assess whether rasagiline reaches its intended target in the body, and whether it has any effect on mitochondria (cellular “energy factories”) and cellular damage and survival.
  3. Secondary outcome measures in the multistate study include changes in rate of disease progression as measured by assessments of pulmonary function, quality of life, safety and survival.

Currently recruiting? These two studies are ongoing but not recruiting participants.

Background info: Testing has shown that treatment with rasagiline improved motor function and survival in a mouse model of ALS. Read the full report, for a fee: Rasagiline Alone and in Combination with Riluzole Prolongs Survival in an ALS Mouse Model.

Additional information: For more information on these trials, including enrollment criteria and contact information, see:

  1. Rasagiline in Subjects with Amyotrophic Lateral Sclerosis (ALS)
  2. Trial of Safety and Efficacy of Rasagiline in Patients with Amyotrophic Lateral Sclerosis (ALS)
  3. Rasagiline in Subjects with Amyotrophic Lateral Sclerosis (ALS)

To read about the other ALS clinical trials:

Note: The effect of these drugs on people with ALS is still unknown. Individuals are strongly advised not to use these drugs to treat ALS until they have been proven safe and effective, and have been approved for use in ALS. Always consult with your physician before adding any medications to your treatment plan. 

About Clinical Trials

About Clinical Trials

A clinical trial is a test, in humans, of an experimental treatment. Although it's possible that benefit may be derived from participating in a clinical trial, it's also possible that no benefit, or even harm, may occur.

MDA has no ability to influence who is chosen to participate in a clinical trial.

To learn more, see Learn About Clinical Studies and Being a Co-Adventurer, which is about neuromuscular disease clinical trials. To see a continuously updated database of clinical trials, go to ClinicalTrials.gov.

Amy Madsen
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