NCT01765257

Brief Summary

Among the psychiatric symptoms observed in the premotor phase of Parkinson's disease (PD) and/or in "de novo" patients, apathy is relatively frequent (estimated to 23%). However, the neuropathological bases of apathy are still unknown. However, recent data suggests that apathy could be linked to a more specific dopaminergic denervation in the ventral striatum. Rasagiline increases the bioavailability of striatal endogenous dopamine by blocking the MAO-B. Some recent data suggest rasagiline could be effective to improve apathy in Parkinson's disease. The primary outcome is to demonstrate a significant reduction of apathy using the Lille apathy rating scale (LARS) in drug naive patients with early diagnosed Parkinson's disease, using a treatment by rasagiline.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 8, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 10, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

January 10, 2013

Status Verified

January 1, 2013

Enrollment Period

1.5 years

First QC Date

January 8, 2013

Last Update Submit

January 9, 2013

Conditions

Drug-naïve Patients With Parkinson's DiseaseApathy

Keywords

Drug-naïve patients with Parkinson's diseaseApathyRasagiline

Outcome Measures

Primary Outcomes (1)

  • Lille Apathy Rating Scale (LARS) score

    at the visit 3 (after 3 months of treatment)

Secondary Outcomes (7)

  • Motor assessment : Unified Parkinson's Disease Rating Scale

    at the visit 3 (after 3 months of treatment)

  • Depressive and anxiety symptoms : MADRS + Hamilton anxiety scale

    at the visit 3 (after 3 months of treatment)

  • Self assessment of apathy : Starkstein

    at the visit 3 (after 3 months of treatment)

  • Quality of life : PDQ 39

    at the visit 3 (after 3 months of treatment)

  • Cognitive assessment: MATTIS dementia rating scale, MMSE, executive functions battery

    at the visit 3 (after 3 months of treatment)

  • +2 more secondary outcomes

Study Arms (2)

rasagiline

EXPERIMENTAL

Randomized, double-blind, rasagiline (1 mg) vs placebo study. Parallel group (randomization 1/1). Duration 3 months 16 recruiting centers in France

Drug: AZILECT®

placebo

PLACEBO COMPARATOR

Randomized, double-blind, rasagiline (1 mg) vs placebo study. Parallel group (randomization 1/1). Duration 3 months 16 recruiting centers in France

Drug: Placebo

Interventions

AZILECT®DRUG
rasagiline
PlaceboDRUG
placebo

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Drug-naïve patients with Parkinson's disease (UKPDBB criteria)
  • No dementia (Mattis dementia rating scale \> 130; Mini Mental Sate Examination ≥26)
  • No depression (MADRS \< 15)
  • Criteria of apathy from Robert et al (2009)
  • At least mild apathy (≥-21 to Lille Apathy Rating Scale)
  • Age : 35-70 y
  • Affiliation to social security
  • Agreement of patients

You may not qualify if:

  • Ongoing severe psychiatric or somatic diseases
  • Others treatments :
  • antipsychotics
  • psychostimulants (methylphenidate, adrafinil, modafinil, deanol, vitamin C, sulbutiamine, glutamic acid, aspartic acid)
  • any contra-indication according to SmPC
  • patients under guardianship
  • Women without efficient contraception
  • Person who participate to an other study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Lethargy

Interventions

rasagiline

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Denis PEZET

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

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

Study Record Dates

First Submitted

January 8, 2013

First Posted

January 10, 2013

Study Start

June 1, 2013

Primary Completion

December 1, 2014

Study Completion

March 1, 2015

Last Updated

January 10, 2013

Record last verified: 2013-01

Locations

FR(1)