Rasagiline for the Symptomatic Treatment of Fatigue in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease; Fatigue
Intervention: Rasagiline; Placebo
Intervention description: Comparison of Rasagiline versus placebo.
Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.; Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks.
Intervention MeSH terms: Rasagiline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Parkinson's Disease; Fatigue

Summary:

      The purpose of the research study is to determine if rasagiline is an effective treatment for
      fatigue in patients with Parkinson's disease (PD).
    

Eligibility criteria:

        Inclusion Criteria:

          1. A clinical diagnosis of idiopathic PD by a movement disorders specialist. All subjects
             will be diagnosed using the UK Brain Bank criteria (Hughes et al., 1992).

          2. Age between 40-85 years.

          3. Able to sign and understand informed consent; and cognitively able to carry out the
             procedures in the study

          4. Stable on all PD medications for at least 30 days; and psychotropic medications for at
             least 90 days.

          5. Treatment naïve subjects who are appropriate candidates to begin MAO-inhibitor
             monotherapy as treatment for their PD may also be included in this study.

          6. Fatigue Severity Scale ≥ 36 (KRupps et al., 1989)

        Exclusion Criteria:

          1. Clinically significant medical disease that is associated independently with fatigue
             (e.g. significant cardiac or pulmonary disease, anemia, obstructive sleep apnea, liver
             or kidney failure).

          2. History of neurological illnesses other than PD or a history of a significant head
             trauma (involving unconsciousness).

          3. Evidence of secondary or atypical parkinsonism as suggested by the presence of any of
             the following: 1) history of stroke(s), 2) exposure to toxins or neuroleptics, 3)
             history of encephalitis, 4) neurological signs of upper motor neuron disease,
             cerebellar involvement, supranuclear gaze palsy, or significant orthostatic
             hypotension.

          4. MRI or CT scan with significant evidence of brain atrophy or other abnormalities (e.g.
             lacunar infarcts or iron deposits in the putamen.

          5. Clinical diagnoses of dementia; or an MMSE score of < 25.

          6. Unstable, newly diagnosed, or newly treated (i.e. less than 3 months) major
             psychiatric disorder such as depression or anxiety

          7. Beck's Depression Inventory score >14.

          8. Current or prior placement of Deep Brain Stimulator.

          9. Currently taking an MAO-B inhibitor or medications which are used as fatigue
             treatments, including amantadine, modafinil, methylphenidate, atomoxetine or other
             psychostimulants.

         10. Previously taken an MAO-B inhibitor for more than 2 weeks.

         11. Hypersensitivity to rasagiline or its products

         12. On mirtazapine, venlafaxine, regular use of compounds with vasoconstrictors, tramadol,
             meperidine, propoxyphene, dextromethorphan, St. John's wort, cyclobenzaprine

         13. On omeprazole, ciprofloxacin or drugs that are metabolized through CYP1A2