Rasagiline for the Symptomatic Treatment of Fatigue in Parkinson's Disease

Completed · Phase 4 · Has a placebo group

Conditions studied: Parkinson's Disease

In brief

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

Key facts

Study ID: NCT01168596
Run by: University of Florida
People needed: 30
Starts: 2009-12-01
Expected to finish: 2012-05-01
Last updated by the study team: 2014-01-10

Who can join

Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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).
Age between 40-85 years.
Able to sign and understand informed consent; and cognitively able to carry out the procedures in the study
Stable on all PD medications for at least 30 days; and psychotropic medications for at least 90 days.
Treatment naïve subjects who are appropriate candidates to begin MAO-inhibitor monotherapy as treatment for their PD may also be included in this study.
Fatigue Severity Scale ≥ 36 (KRupps et al., 1989)

You may not qualify if…

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).
History of neurological illnesses other than PD or a history of a significant head trauma (involving unconsciousness).
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.
MRI or CT scan with significant evidence of brain atrophy or other abnormalities (e.g. lacunar infarcts or iron deposits in the putamen.
Clinical diagnoses of dementia; or an MMSE score of < 25.
Unstable, newly diagnosed, or newly treated (i.e. less than 3 months) major psychiatric disorder such as depression or anxiety
Beck's Depression Inventory score >14.
Current or prior placement of Deep Brain Stimulator.
Currently taking an MAO-B inhibitor or medications which are used as fatigue treatments, including amantadine, modafinil, methylphenidate, atomoxetine or other psychostimulants.
Previously taken an MAO-B inhibitor for more than 2 weeks.
Hypersensitivity to rasagiline or its products
On mirtazapine, venlafaxine, regular use of compounds with vasoconstrictors, tramadol, meperidine, propoxyphene, dextromethorphan, St. John's wort, cyclobenzaprine
On omeprazole, ciprofloxacin or drugs that are metabolized through CYP1A2

Where it is running

University of Colorado Anschutz outpatient Pavilion — Aurora, Colorado, United States
Shands and University of Florida Medical Plaza — Gainesville, Florida, United States
Cleveland Clinic Center for Neurological Restoration — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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