Rasagiline and Apathy in Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

A Randomised Placebo-controlled Trial of Rasagiline in Parkinson Disease Patients With Symptoms of Apathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00755027
• Other study ID #: FIRHSCSP/07/14
• Secondary ID: 2007-004400-12
• Status: Completed
• Phase: Phase 4
• First received: September 17, 2008
• Last updated: August 7, 2015
• Start date: September 2008
• Est. completion date: June 2014

Study information

• Verified date: August 2015
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether rasagiline is effective in the treatment of apathy in patients with Parkinson's disease.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Rasagiline
rasagiline 1 mg daily, oral use, during 12 weeks

Locations

Country	Name	City	State
Spain	Fundacio de Gestio Sanitaria de l'Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		week 12	No
Secondary	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		week 12	No