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

Primary Purpose

Drug-naïve Patients With Parkinson's Disease, Apathy

Status

Unknown status

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

AZILECT®

Placebo

About this trial

This is an interventional treatment trial for Drug-naïve Patients With Parkinson's Disease focused on measuring Drug-naïve patients with Parkinson's disease, Apathy, Rasagiline

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CHU Clermont-Ferrand

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

rasagiline

placebo

Arm Description

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

Outcomes

Primary Outcome Measures

Lille Apathy Rating Scale (LARS) score

Secondary Outcome Measures

Motor assessment : Unified Parkinson's Disease Rating Scale

Depressive and anxiety symptoms : MADRS + Hamilton anxiety scale

Self assessment of apathy : Starkstein

Quality of life : PDQ 39

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

Hyperdopaminergic symptoms : Parkinson's disease behavioral scale

Fatigue assessment : Parkinson Fatigue Scale

Full Information

NCT ID

NCT01765257

First Posted

January 8, 2013

Last Updated

January 9, 2013

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

H. Lundbeck A/S, CHU Purpan (Toulouse), Hôpital Haut-Lévêque, Centre Hospitalier de la côte Basque, Poitiers University Hospital, CHU de Rennes (Rennes), University Hospital, Lille, Hôpital Dupuytren, University Hospital, Caen, Centre Hospitalier Universitaire de Nīmes, Centre Hospitalier du Pays d'Aix, Hôpital de la Timone (MARSEILLE), University Hospital, Rouen, Centre Hospitalier Universitaire, Amiens, Centre Hospitalier Universitaire de Saint Etienne, Fondation Rothschild Paris

1. Study Identification

Unique Protocol Identification Number

NCT01765257

Brief Title

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

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Unknown status

Study Start Date

June 2013 (undefined)

Primary Completion Date

December 2014 (Anticipated)

Study Completion Date

March 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Clermont-Ferrand

Collaborators

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Drug-naïve Patients With Parkinson's Disease, Apathy

Keywords

Drug-naïve patients with Parkinson's disease, Apathy, Rasagiline

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

rasagiline

Arm Type

Experimental

Arm Description

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

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

AZILECT®

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Lille Apathy Rating Scale (LARS) score

Time Frame