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.
The specific aim of this screen study is to determine whether rasagiline is safe in this patient population and if the drug has the potential to slow ALS disease progression
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
rasagiline 2 mg daily for 12 months
Phoenix Neurological Institute
Phoenix, Arizona, United States
California Pacific Medical Center
San Francisco, California, United States
University of Iowa
Iowa City, Iowa, United States
University Of Kansas Medical Center
Kansas City, Kansas, United States
University of Minnesota
Minneapolis, Minnesota, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Tennessee
Memphis, Tennessee, United States
The Methodist Hospital System
Houston, Texas, United States
McGill University
Montreal, Quebec, Canada
Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R)
The primary outcome measure is the difference in the rate of decline in function, as detected by the ALS Functional Rating Scale - Revised (ALSFRS-R) in patients taking rasagiline compared to a database of patients from randomized clinical trials conducted during 1997-2007. Minimum score is 0 (no function) to Maximum score is 48 (normal function)
Time frame: up to 12 months
Difference in Time to Treatment Failure
This group is defined as death, endotracheal intubation, tracheostomy-assisted ventilation or use of noninvasive ventilation \>= 23 hours/day for 14 days or more.
Time frame: up to 12 months
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