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. 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).
Study Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis (ALS)
Study Type:
Interventional
Type of Intervention:
Drug
Intervention Name:
Rasagiline, Placebo
Placebo:
Phase:
Phase 2
Study Chair(s)/Principal Investigator(s):
Richard Barohn, MD, University of Kansas Medical Center
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
University of Kansas
Kansas City, Kansas, 66160 United States
Full Study Summary:
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.
Study Sponsor:
Richard Barohn, MD
Participant Duration:
12 months
Estimated Enrollment:
80
Estimated Study Start Date:
11 / 21 / 2013
Estimated Study Completion Date:
07 / 27 / 2016
Posting Last Modified Date:
01 / 27 / 2020
Date Study Added to neals.org:
02 / 08 / 2013
Minimum Age:
21 Years
Maximum Age:
80 Years
Can participants use Riluzole?
Yes
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 2 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 propoxyphene, flexeril.
4. Patients on fluoxetine or fluvoxamine.
5. Patients taking amitriptyline > 50 mg/d, trazodone and sertraline > 100 mg/d, citalopram > 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. Has a diaphragm pacing device or plan on obtaining a diaphragm pacing device during the course of the study.
9. History of renal disease.
10. History of liver disease.
11. Current pregnancy or lactation.
12. Limited mental capacity such that the patient cannot provide written informed consent or comply with evaluation procedures.
13. History of recent alcohol or drug abuse or noncompliance with treatment or other experimental protocols.
14. Vital Capacity (VC) < 75% of predicted.
15. Receipt of any investigational drug within the past 30 days.
16. Women with the potential to become pregnant who are not practicing effective birth control.
17. Poorly controlled hypertensive subjects or resting systolic blood pressure (SBP) > 160 mmHg and/or diastolic (DBP) > 95 mmHg.
18. Use of BiPAP at screening.
Phoenix Neurological Associates
Phoenix, Arizona
85018
United States
University of California - Irvine
Irvine, California
92868
United States
California Pacific Medical Center
San Francisco, California
94115
United States
University of Kansas Medical Center
Kansas City, Kansas
66160
United States
St. Louis University
Saint Louis, Missouri
63104
United States
University of Nebraska
Omaha, Nebraska
68198
United States
Columbia University
New York, New York
10032
United States
Oregon Health and Science University
Portland, Oregon
97239
United States
University of Pennsylvania
Philadelphia, Pennsylvania
19107
United States
UT Southwestern Medical Center
Dallas, Texas
75390
United States