Rasagiline in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis (ALS)
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Intervention: Rasagiline; Placebo
Intervention description: Rasagiline 2mg once a day for 12 months.; Placebo (looks like study drug but has no active ingredients) once a day for 12 months.
Intervention MeSH terms: Rasagiline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 80.0
Sex: All
Minimum age: 21 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      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).
    

Eligibility criteria:

        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.