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

NCT01168596 | Completed Phase 4 Results

• 1 other identifier: 20091035
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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).

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease; Fatigue

Outcome Measures

Primary Outcomes (1)

• Modified Fatigue Impact Scale (MFIS)

  The MFIS rates how much of a problem fatigue has caused the subjects during the past month, including the day of testing. It consists of 21 questions of fatigue on quality of life. Each subject is asked to circle the appropriate response for each item: 0=never, 1=rarely, 2=sometimes, 3=often, 4=always, 5=almost always. The minimum score is 0 and the maximum is 105. The higher the score, the more fatigue the subject.

  Change from baseline to week 12

Secondary Outcomes (6)

• Fatigue Severity Scale (FSS)

  Change from baseline to week 12

• Multidimensional Fatigue Inventory (MFIS)

  Change from baseline to week 12

• PD Quality of Life Scale (PDQ39)

  Change from baseline to week 12

• Paced Auditory Serial Addition Test (PASAT)

  Change from baseline to week 12

• Finger Tapping

  Change from baseline to week 12

Other Outcomes (13)

• Parkinson's Disease Sleep Scale (PDSS)

  Change from baseline to week 12

• Marin Apathy Inventory (Apathy Evaluation Scale)

  Change from baseline to week 12

• Visual Analog Scale - Subset: Afraid

  Change from baseline to week 12

Study Arms (2)

sugar pill

PLACEBO COMPARATOR

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

Drug: Placebo

rasagiline

ACTIVE COMPARATOR

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

Drug: Rasagiline

Interventions

Rasagiline DRUG

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

Also known as: Azilect

rasagiline

Placebo DRUG

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

sugar pill

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (3)

University of Colorado Anschutz outpatient Pavilion

Aurora, Colorado, 80045, United States

Location

Shands and University of Florida Medical Plaza

Gainesville, Florida, 32610, United States

Location

Cleveland Clinic Center for Neurological Restoration

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Fatigue

Interventions

rasagiline

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Irene A. Malaty, MD
• Organization: University of Florida Center for Movement Disorders and Neurorestoration

Irene.Malaty@neurology.ufl.edu

352-273-5550

Study Officials

• Irene A Malaty, MD

  University of Florida Department of Neurology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2010
• First Posted: July 23, 2010
• Study Start: December 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: January 10, 2014
• Results First Posted: January 10, 2014

Record last verified: 2012-09

Locations

US (3)