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

NCT ID: NCT01168596

Last Updated: 2014-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2012-05-31

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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

sugar pill

Placebo tablet, 1 per day, duration is approximately 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks.

rasagiline

Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.

Group Type: ACTIVE_COMPARATOR

Rasagiline

Intervention Type: DRUG

Comparison of Rasagiline versus placebo.

Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.

Interventions

Rasagiline

Comparison of Rasagiline versus placebo.

Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.

Intervention Type: DRUG

Placebo

Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks.

Intervention Type: DRUG

Other Intervention Names

Azilect

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Irene A Malaty, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida Department of Neurology

Locations

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

Countries

United States

Other Identifiers

20091035

Identifier Type: -

Identifier Source: org_study_id