Rasagiline in Subjects With Amyotrophic Lateral Sclerosis (ALS)

Status:	Active, not recruiting
Conditions:	Neurology, Neurology, Neurology, ALS
Therapuetic Areas:	Neurology, Other
Healthy:	No
Age Range:	21 - 80
Updated:	1/25/2017
Start Date:	September 2012
End Date:	August 2017

Phase 2 Study of Rasagiline for Treatment of Amyotrophic Lateral Sclerosis

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.

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.

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,
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. 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 blood pressure SBP > 160 mmHg
and/or DBP > 95 mmHg.

18. Use of BiPAP at screening.

We found this trial at

sites

University of Nebraska

Omaha, Nebraska 68198

from

Omaha, NE