Phase 4 N=30 Randomized Triple-blind Treatment

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

Parkinson's Disease

Bottom Line

View on ClinicalTrials.gov: NCT01168596 ↗

Enrolled (actual)

Serious AEs

3.3%

Results posted

Jan 2014

Primary outcome: Primary: Modified Fatigue Impact Scale (MFIS) — 12.92; 12.69 units on a scale — p=0.81

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Rasagiline (Drug); Placebo (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: University of Florida
Primary completion: May 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Modified Fatigue Impact Scale (MFIS)	12.92; 12.69	0.81
SECONDARY Fatigue Severity Scale (FSS)	12.38; 2.25	0.23
SECONDARY Multidimensional Fatigue Inventory (MFIS)	2.62; 6.83	0.75
SECONDARY PD Quality of Life Scale (PDQ39)	7.54; 5.67	0.54
SECONDARY Paced Auditory Serial Addition Test (PASAT)	-11.31; -10.31	0.42
SECONDARY Finger Tapping	.46; -0.23	0.44
SECONDARY Hand-grip Strength	-9.08; -8.36	0.82

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

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)

Exclusion Criteria

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01168596). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.