NCT01765257

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

Evaluation of the Efficacy of Rasagiline in Apathy in Drug-naïve Patients With Parkinson's Disease by a Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Study.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Drug-naïve Patients With Parkinson's Disease
• Apathy

Interventions

Type	Name	Description
DRUG	AZILECT®
DRUG	Placebo

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-12-01
• Completion: 2015-03-01
• First posted: 2013-01-10
• Last updated: 2013-01-10

Locations

1 site across 1 country: France