Evaluation of the Efficacy of Rasagiline in Apathy in Drug-naïve Patients With Parkinson's Disease by a Multi-center Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-03-31

Brief Summary

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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.

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Detailed Description

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Study design :

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

Population :

50 drug-naïve patients with Parkinson's disease, with apathy. 2 groups : 25 patients with placebo and 25 patients with rasagiline.

3 visits

* Visit 1 : inclusion / randomisation/ first study medication dispensation
* Visit 2 (1.5 month after V1) : first evaluation and second study medication dispensation.
* Visit 3 (3 months after V1, final visit) : second evaluation

Conditions

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Drug-naïve Patients With Parkinson's Disease Apathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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rasagiline

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

Group Type EXPERIMENTAL

AZILECT®

Intervention Type DRUG

placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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AZILECT®

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- 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

Exclusion Criteria

* \- Any antiparkinsonian treatment (L.dopa, dopamine agonists, MAO-B-I, amantadine, anticholinergics). Patients treated by dopamine agonists but who have stopped it more than 3 months before their inclusion can be included.
* Ongoing severe psychiatric or somatic diseases
* Others treatments :
* antipsychotics
* antidepressants and anxiolytics (exclusion if the treatment is not stable the month before inclusion)
* 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

Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No