Update (Feb. 4, 2014): This trial is now closed to new participants.
Name: Ozanezumab (GSK1223249)
How it works: Ozanezumab, developed by GlaxoSmithKline, is thought to work by helping protect neuromuscular junctions, where muscles interact with nerves. The drug may help repair damaged axons, the long fibers that carry signals to and from nerve cells in the brain and spinal cord.
Purpose of trial: Assess efficacy and safety of intravenous (injected into a vein) ozanezumab compared to placebo in people with ALS.
Type of trial: Multinational, 48-week, phase 2 trial involving approximately 300 people with ALS.
Trial sites: Australia, Belgium, Canada, France, Germany, Italy, Japan, the Netherlands and the United Kingdom. (No trial sites are planned in the U.S.)
- The primary outcome measure is the effect of ozanezumab on the physical function and survival of people with ALS over a treatment period of 48 weeks.
- Secondary outcome measures are clinical outcomes associated with ALS, such as respiratory function, muscle strength, progression-free survival and overall survival.
- Other outcome measures: Quality of life, safety, tolerability, immune response and pharmacokinetics (how the drug is absorbed, distributed, metabolized and excreted by the body).
Currently recruiting? GSK currently is recruiting trial participants.
Background info: Listen to a podcast about ozanezumab's potential to treat ALS featuring neurologist Pierre-François Pradat at Hôpital de la Pitié-Salpétrière in Paris, at A Go for Anti-Nogo-A (click on podcast play button at the bottom of the post).
Additional info: For information on this trial, enrollment criteria and contact information, see Study of Ozanezumab (GSK1223249) Versus Placebo in the Treatment of Amyotrophic Lateral Sclerosis.
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
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.