Trial | NCT01765257  Report issue

Title

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.

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    rasagiline ...

  • Study Participants

    50
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.
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 Started
Jun 30
2013
Primary Completion
Dec 31
2014
Anticipated
Study Completion
Mar 31
2015
Anticipated
Last Update
Jan 10
2013
Estimate

Drug AZILECT®

Drug Placebo

rasagiline Experimental

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

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

Criteria 

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
No Results Posted