Amyotrophic Lateral Sclerosis (ALS) Clinical Trial
Official title:
Phase 2 Study of Rasagiline for Treatment of Amyotrophic Lateral Sclerosis
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. Motor neurons are responsible for sending signals to muscles in our
bodies to trigger movement. 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, but the effectiveness of rasagiline for patients
with ALS has not been tested. Rasagiline is approved for the treatment of Parkinson's
disease.
Rasagiline for treatment of ALS is not approved by the U.S. Food and Drug Administration
(FDA) and is investigational. Investigational drugs are studied to find out if they are safe
and effective in the treatment of diseases or conditions.
By doing this study, researchers hope to learn if rasagiline is safe and slows disease
progression in patients with ALS.
Funding Source - FDA OOPD (FDA Orphan Products Division).
The study is a phase II, double-blind, placebo-controlled, multicenter study of rasagiline 2mg/day. Subjects will be assigned to either active agent or placebo (3:1) for twelve months. Subjects will undergo outpatient evaluations at screening, baseline, and months 1, 2, 4, 6, 8, 10 and 12 and telephone assessments at months 3, 5, 7 and 9. There will be a close-out phone call 30 days post month 12. ;
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