Rasagiline for the Symptomatic Treatment of Fatigue in Parkinson's Disease (REST)
This study has been completed.
Sponsor:
University of Florida
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01168596
First received: February 19, 2010
Last updated: September 17, 2012
Last verified: September 2012
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Purpose
The purpose of the research study is to determine if rasagiline is an effective treatment for fatigue in patients with Parkinson's disease (PD).
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson's Disease |
Drug: Rasagiline Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Rasagiline for the Symptomatic Treatment of Fatigue in Parkinson's Disease: A Bi-Center, Placebo-Controlled Study (The REST Fatigue Trial) |
Resource links provided by NLM:
Further study details as provided by University of Florida:
Primary Outcome Measures:
- Change in Modified Fatigue Impact Scale [ Time Frame: Approximately one year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in the Fatigue Severity Scale [ Time Frame: Approximately one year ] [ Designated as safety issue: No ]
| Enrollment: | 31 |
| Study Start Date: | December 2009 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: sugar pill |
Drug: Placebo
Comparison of Rasagiline versus placebo.
|
| Active Comparator: rasagiline |
Drug: Rasagiline
Comparison of Rasagiline versus placebo. Rasagiline tablet, 1 mg, 1 per day, duration is approximately 3 months. Other Name: Azilect
|
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| Ages Eligible for Study: | 40 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 < 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01168596
Locations
| United States, Colorado | |
| University of Colorado Anschutz outpatient Pavilion | |
| Aurora, Colorado, United States, 80045 | |
| United States, Florida | |
| Shands and University of Florida Medical Plaza | |
| Gainesville, Florida, United States, 32610 | |
| United States, Ohio | |
| Cleveland Clinic Center for Neurological Restoration | |
| Cleveland, Ohio, United States, 44195 | |
Sponsors and Collaborators
University of Florida
Investigators
| Principal Investigator: | Irene A Malaty, MD | University of Florida Department of Neurology |
More Information
No publications provided
| Responsible Party: | University of Florida |
| ClinicalTrials.gov Identifier: | NCT01168596 History of Changes |
| Other Study ID Numbers: | 20091035 |
| Study First Received: | February 19, 2010 |
| Last Updated: | September 17, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Florida:
|
Parkinson's Disease Fatigue |
Additional relevant MeSH terms:
|
Fatigue Parkinson Disease Signs and Symptoms Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |
Rasagiline Monoamine Oxidase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Neuroprotective Agents Protective Agents Physiological Effects of Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013