NCT00755027

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2008

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 18, 2008

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

August 10, 2015

Status Verified

August 1, 2015

Enrollment Period

5.8 years

First QC Date

September 17, 2008

Last Update Submit

August 7, 2015

Conditions

Parkinson's Disease

Keywords

Parkinson's diseaseApathyRasagiline

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 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

Interventions

RasagilineDRUG

rasagiline 1 mg daily, oral use, during 12 weeks

Also known as: Azilect

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundacio de Gestio Sanitaria de l'Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

MeSH Terms

Conditions

Parkinson DiseaseLethargy

Interventions

rasagiline

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jaime Kulisevsky, MD,PhD

    Neurology Service at Hospital de la Santa Creu i Sant Pau, Autonomous University of Barcelona (Barcelona, Spain)

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 17, 2008

First Posted

September 18, 2008

Study Start

September 1, 2008

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

August 10, 2015

Record last verified: 2015-08

Locations

ES(1)