Clinical trial NCT01168596: Rasagiline for the Symptomatic Treatment of Fatigue in Parkinson's Disease
Official title: Rasagiline for the Symptomatic Treatment of Fatigue in Parkinson's Disease: A Bi-Center, Placebo-Controlled Study (The REST Fatigue Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease
Fatigue
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2010-07-23
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: Despite the fact that fatigue affects 40-50% of all patients with PD and is a leading cause of disability, we currently do not have any effective treatments for this symptom. Rasagiline is a well-tolerated and effective treatment for the motor symptoms of PD. Rasagiline is a MAO-B inhibitor that may decrease the breakdown of dopamine. Many patients report an improvement in their energy levels when on this medication. A proven treatment for PD fatigue would significantly improve the quality of life for numerous patients and their caregivers.

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

Primary outcomes:
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: Change from baseline to week 12
Secondary outcomes:
measure: Fatigue Severity Scale (FSS)
timeFrame: Change from baseline to week 12
measure: Multidimensional Fatigue Inventory (MFIS)
timeFrame: Change from baseline to week 12
measure: PD Quality of Life Scale (PDQ39)
timeFrame: Change from baseline to week 12
measure: Paced Auditory Serial Addition Test (PASAT)
timeFrame: Change from baseline to week 12
measure: Finger Tapping
timeFrame: Change from baseline to week 12
measure: Hand-grip Strength
timeFrame: Change from baseline to week 12
Other outcomes:
measure: Parkinson's Disease Sleep Scale (PDSS)
timeFrame: Change from baseline to week 12
measure: Marin Apathy Inventory (Apathy Evaluation Scale)
timeFrame: Change from baseline to week 12
measure: Visual Analog Scale - Subset: Afraid
timeFrame: Change from baseline to week 12
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: Change from baseline to week 12
measure: Becks Depression Inventory (BDI-II)
timeFrame: Change from baseline to week 12
measure: Unified Parkinson's Disease Rating Scale - Motor (UPDRS Part III)
timeFrame: Change from baseline to week 12
measure: Visual Analog Scale - Subset: Confused
timeFrame: Change from baseline to week 12
measure: Visual Analog Scale - Subset: Sad
timeFrame: Change from baseline to week 12
measure: Visual Analog Scale - Subset: Angry
timeFrame: Change from baseline to week 12
measure: Visual Analog Scale - Subset: Energetic
timeFrame: Change from baseline to week 12
measure: Visual Analog Scale - Subset: Tired
timeFrame: Change from baseline to week 12
measure: Visual Analog Scale - Subset: Happy
timeFrame: Change from baseline to week 12
measure: Visual Analog Scale - Subset: Tense
timeFrame: Change from baseline to week 12
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz outpatient Pavilion
state: Colorado
city: Gainesville
country: United States
facility: Shands and University of Florida Medical Plaza
state: Florida
city: Cleveland
country: United States
facility: Cleveland Clinic Center for Neurological Restoration
state: Ohio
Study officials:
affiliation: University of Florida Department of Neurology
name: Irene A Malaty, MD
role: PRINCIPAL_INVESTIGATOR
References: