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

Phase 4

• Conditions: Drug-naïve Patients With Parkinson's Disease; Apathy
• Interventions: Drug: AZILECT®; Drug: Placebo

• Registration Number: NCT01765257
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Detailed Description

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

Study Timeline

• Status Verified: 2013-01
• Study First Submitted: 2013-01-08
• Study First Submitted QC: 2013-01-09
• Last Update Submitted: 2013-01-09
• Study First Posted: 2013-01-10
• Last Update Posted: 2013-01-10
• Study Start: 2013-06
• Primary Completion: 2014-12
• Study Completion: 2015-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Lille Apathy Rating Scale (LARS) score	at the visit 3 (after 3 months of treatment)

Secondary Outcome Measures

Name	Time	Method
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)
Hyperdopaminergic symptoms : Parkinson's disease behavioral scale	at the visit 3 (after 3 months of treatment)
Fatigue assessment : Parkinson Fatigue Scale	at the visit 3 (after 3 months of treatment)

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France