Rasagiline and Apathy in Parkinson's Disease

This study has been completed.
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
First received: September 17, 2008
Last updated: August 7, 2015
Last verified: August 2015
The purpose of this study is to determine whether rasagiline is effective in the treatment of apathy in patients with Parkinson's disease.

Condition Intervention Phase
Parkinson's Disease
Drug: Rasagiline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Placebo-controlled Trial of Rasagiline in Parkinson Disease Patients With Symptoms of Apathy

Resource links provided by NLM:

Further study details as provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

Primary Outcome Measures:
  • The primary outcome measure will be the mean change from baseline to study endpoint (week 12) in apathy scores as measured by the Lille Apathy Rating Scale (LARS)and the Apathy Scale [ Time Frame: week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary outcome measures will include change from baseline to study endpoint on a range of scales assessing apathy, depression, other neuropsychiatric symptoms, cognition, sleepiness and quality of life [ Time Frame: week 12 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: September 2008
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Rasagiline
    rasagiline 1 mg daily, oral use, during 12 weeks
    Other Name: Azilect
Detailed Description:
The primary objective of this study is to evaluate the efficacy of rasagiline in patients with Parkinson's disease (PD) and apathy. Secondary objectives are 1) to evaluate the affective and cognitive response to rasagiline and their correlates to apathy and 2) to investigate the metabolic and neurophysiologic correlates of the behavioural, cognitive and emotional, aspects of apathy in PD. This will be an exploratory, randomized, double-blind, placebo controlled, parallel-group study. 40 PD patients with apathy and without dementia will be recruited. Rasagiline 1 mg or matching placebo will be administered once daily in conjunction with the subjects' usual oral antiparkinsonian medications for up to 12 weeks. Patients will be evaluated at screening (-7 days) and baseline (0), as well as at weeks 4, 8, and 12. A perfusion SPECT will be performed at baseline and at week 12. The study will be conducted at the Movement Disorders Unit of the Neurology Department at Sant Pau Hospital (Barcelona, Spain).

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with idiopathic PD optimally treated for their motor deficits with stable doses of L-Dopa and/or dopamine agonists and showing a non-zero score on the item 4 (motivation/initiative) of the Unified Parkinson's Disease Rating Scale (UPDRS)

Exclusion Criteria:

  • Dementia associated to PD according to DSM IV criteria. History of primary psychiatric illness or Axis I diagnoses according to the Structured Clinical Interview for DSM-IV
  • Patients complaining of acute mood or cognitive fluctuations in response to dopaminergic medication
  • Patients treated with any MAO inhibitor (including Selegiline), fluoxetine and fluvoxamine during the previous month before inclusion. Also will be excluded patients with a neurological disorder other than PD, any unstable systemic disease and pregnant or possibly pregnant women
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00755027

Fundacio de Gestio Sanitaria de l'Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Principal Investigator: Jaime Kulisevsky, MD,PhD Neurology Service at Hospital de la Santa Creu i Sant Pau, Autonomous University of Barcelona (Barcelona, Spain)
  More Information

Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT00755027     History of Changes
Other Study ID Numbers: FIRHSCSP/07/14  2007-004400-12 
Study First Received: September 17, 2008
Last Updated: August 7, 2015
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
Parkinson's disease

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Monoamine Oxidase Inhibitors
Neuroprotective Agents
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on May 26, 2016