A Multi-Center Controlled Screening Trial of Safety and Efficacy of Rasagiline in Subjects With Amyotrophic Lateral Sclerosis (ALS)

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.

Study Status:

Not recruiting


Amyotrophic Lateral Sclerosis (ALS)

Study Type:


Type of Intervention:


Intervention Name:




Phase 2

Study Chair(s)/Principal Investigator(s):

Yunxia Wang, MD, University of Kansas Medical Center

Clinicaltrials.gov ID:


Neals Affiliated?


Coordinating Center Contact Information

University of Kansas

Kansas City, Kansas, United States

Full Study Summary:

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 Sponsor:

Yunxia Wang, MD

Estimated Enrollment:


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

The recruitment status of this study is unknown because the information has not been verified on clinicaltrials.gov recently.

Minimum Age:

21 Years

Maximum Age:

80 Years

Inclusion 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).

Exclusion criteria

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

Phoenix, Arizona 85018
United States

California Pacific Medical Center

San Francisco, California 94118
United States

University of Iowa

Iowa City, Iowa 52242
United States

University Of Kansas Medical Center

Kansas City, Kansas 66160
United States

University of Minnesota

Minneapolis, Minnesota 55414
United States

University of Nebraska Medical Center

Omaha, Nebraska 68198
United States

University of Pennsylvania

Philadelphia, Pennsylvania 19104
United States

University of Tennessee

Memphis, Tennessee 38104
United States

The Methodist Hospital System

Houston, Texas 77030
United States

McGill University

Montreal, Quebec H3A 2B4