Rasagiline in Subjects With Amyotrophic Lateral Sclerosis (ALS)

Completed · Phase 2 · Has a placebo group

Conditions studied: Amyotrophic Lateral Sclerosis (ALS)

In brief

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).

Key facts

Study ID

NCT01786603

Run by

Richard Barohn, MD

People needed

80

Starts

2013-11-21

Expected to finish

2016-07-27

Last updated by the study team

2020-01-27

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A clinical diagnosis of laboratory-supported probable, probable, or definite ALS, according to a modified El Escorial criteria, by the study investigator (Appendix IV).
• 21 to 80 years of age inclusive.
• VC greater or equal to 75% of predicted at screening and baseline.
• Onset of weakness within 2 years prior to enrollment.
• If patients are taking riluzole for ALS, they must be on a stable dose for at least thirty days prior to the baseline visit.
• 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.
• Willing and able to give signed informed consent that has been approved by the Institutional Review Board (IRB).

You may not qualify if…

• Requirement for tracheotomy ventilation or non-invasive ventilation for > 23 hours per day.
• Patients on sympathomimetic agents. This includes pseudoephedrine, phenylephrine, phenylpropanolamine, and ephedrine.
• Patients on analgesics with serotoninergic properties such as meperidine, tramadol, methadone and propoxyphene, flexeril.
• Patients on fluoxetine or fluvoxamine.
• Patients taking amitriptyline > 50 mg/d, trazodone and sertraline > 100 mg/d, citalopram > 20 mg/d or paroxetine > 30 mg/d.
• Diagnosis of other neurodegenerative diseases (Parkinson disease, Alzheimer disease, etc).
• Clinically significant history of unstable medical illness (unstable angina, advanced cancer, etc) over the last 30 days.
• Has a diaphragm pacing device or plan on obtaining a diaphragm pacing device during the course of the study.
• History of renal disease.
• History of liver disease.
• Current pregnancy or lactation.
• Limited mental capacity such that the patient cannot provide written informed consent or comply with evaluation procedures.
• History of recent alcohol or drug abuse or noncompliance with treatment or other experimental protocols.
• Vital Capacity (VC) < 75% of predicted.
• Receipt of any investigational drug within the past 30 days.
• Women with the potential to become pregnant who are not practicing effective birth control.
• Poorly controlled hypertensive subjects or resting systolic blood pressure (SBP) > 160 mmHg and/or diastolic (DBP) > 95 mmHg.
• Use of BiPAP at screening.

Where it is running

• Phoenix Neurological Associates — Phoenix, Arizona, United States
• University of California - Irvine — Irvine, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• St. Louis University — St Louis, Missouri, United States
• University of Nebraska — Omaha, Nebraska, United States
• Columbia University — New York, New York, United States
• Oregon Health and Science University — Portland, Oregon, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• UT Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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