Clinical trial: Rasagiline in Subjects With Amyotrophic Lateral Sclerosis (ALS) (NCT01786603)

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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
Subject must be at most 80 Years

Patient description (medical language): A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year.  Over the last few months, he has also noticed weakness in the right upper extremity.  BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor.  Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS.

Patient description (patient's own words): I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my  PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis.

Does the patient match the trial criteria? Entailment