Trial of Safety and Efficacy of Rasagiline in Patients With Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis (ALS)
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Intervention: rasagiline
Intervention description: rasagiline 2 mg daily for 12 months
Intervention MeSH terms: Rasagiline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
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. 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.
    

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 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.