Trial of Safety and Efficacy of Rasagiline in Patients With Amyotrophic Lateral Sclerosis (ALS)

Summary

ALS is a disorder that weakens motor strength and lung function. Rapid loss of motor neurons in the brain and spinal cord of ALS patients causes the symptoms of increasing weakness and loss of muscle function. While there are drugs to help relieve symptoms of ALS, there is no cure for ALS. Rasagiline is a drug with possible neuroprotective characteristics. Neuroprotective means that the nervous system may be protected against weakening. It is known that rasagiline has possible neuroprotective characteristics and it is approved for use for patients with another disorder, the effectiveness of rasagiline for patients with ALS has not been tested.

Timeline

Start

2011-12

Primary completion

2013-05

Completion

2013-05

Outcome

Missed primary endpoint

registry analysis (superiority test); ALSRFS-R Slope - Rasagiline vs ALSFRS-R - Historical Placebo Control; p = 0.07; Mean Difference (Final Values) -0.25 (95% CI -0.53 to 0.02); NCT01232738 ↗

Drugs

Indications