Study Purpose: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.
Amyotrophic Lateral Sclerosis (ALS)
Type of Intervention:
Study Chair(s)/Principal Investigator(s):
Yunxia Wang, MD, University of Kansas Medical Center
Coordinating Center Contact Information
University of Kansas
Kansas City, Kansas, United States
Full Study Summary:
Yunxia Wang, MD
Estimated Study Start Date:
08 / 31 / 2010
Estimated Study Completion Date:
05 / 01 / 2013
Posting Last Modified Date:
05 / 18 / 2018
Date Study Added to neals.org:
11 / 02 / 2010
80 YearsInclusion Criteria:
1. A clinical diagnosis of laboratory-supported probable, probable, or definite ALS, according to a modified El Escorial criteria, by the study investigator (Appendix IV).
2. 21 to 80 years of age inclusive.
3. VC greater or equal to 75% of predicted at screening and baseline.
4. Onset of weakness within 3 years prior to enrollment.
5. If patients are taking riluzole for ALS, they must be on a stable dose for at least thirty days prior to the baseline visit.
6. Women of childbearing age must be non-lactating and surgically sterile or using an effective method of birth control and have a negative pregnancy test.
7. Willing and able to give signed informed consent that has been approved by the Institutional Review Board (IRB).
1. Requirement for tracheotomy ventilation or non-invasive ventilation for > 23 hours per day.
2. Patients on sympathomimetic agents. This includes pseudoephedrine, phenylephrine, phenylpropanolamine, and ephedrine.
3. Patients on analgesics with serotoninergic properties such as meperidine, tramadol, methadone and propoxyphen, flexeril.
4. Patients on fluoxetine or fluvoxamine.
5. Patients taking amitriptyline > 50 mg/d, trazodone and sertraline > 100 mg/d, citalogram > 20 mg/d or paroxetine > 30 mg/d.
6. Diagnosis of other neurodegenerative diseases (Parkinson disease, Alzheimer disease, etc).
7. Clinically significant history of unstable medical illness (unstable angina, advanced cancer, etc) over the last 30 days.
8. History of renal disease.
9. History of liver disease.
10. Current pregnancy or lactation.
11. Limited mental capacity such that the patient cannot provide written informed consent or comply with evaluation procedures.
12. History of recent alcohol or drug abuse or noncompliance with treatment or other experimental protocols.
13. VC < 75% of predicted.
14. Receipt of any investigational drug within the past 30 days.
15. Women with the potential to become pregnant who are not practicing effective birth control.
Phoenix Neurological Institute
California Pacific Medical Center
San Francisco, California
University of Iowa
Iowa City, Iowa
University Of Kansas Medical Center
Kansas City, Kansas
University of Minnesota
University of Nebraska Medical Center
University of Pennsylvania
University of Tennessee
The Methodist Hospital System