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.

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 Overview

• Status: Unknown
• Conditions: Apathy; Drug-naïve Patients With Parkinson's Disease
• Intervention / Treatment: Drug: Placebo; Drug: AZILECT®

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • CHU Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: rasagiline; Randomized, double-blind, rasagiline (1 mg) vs placebo study. Parallel group (randomization 1/1). Duration 3 months 16 recruiting centers in France	Drug: AZILECT®
Placebo Comparator: placebo; Randomized, double-blind, rasagiline (1 mg) vs placebo study. Parallel group (randomization 1/1). Duration 3 months 16 recruiting centers in France	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Lille Apathy Rating Scale (LARS) score	at the visit 3 (after 3 months of treatment)

Secondary Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: University Hospital, Rouen; Centre Hospitalier Universitaire de Saint Etienne; H. Lundbeck A/S; Centre Hospitalier Universitaire, Amiens; Poitiers University Hospital; Centre Hospitalier de la côte Basque; University Hospital, Caen; Centre Hospitalier Universitaire de Nīmes; University Hospital, Lille; Fondation Rothschild Paris; Hôpital Haut-Lévêque; Centre Hospitalier du Pays d'Aix; Hôpital de la Timone (MARSEILLE); Hôpital Dupuytren; CHU Purpan (Toulouse); CHU de Rennes (Rennes)
• Investigators: Principal Investigator: Denis PEZET, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): March 1, 2015

Study Registration Dates

• First Submitted: January 8, 2013
• First Submitted That Met QC Criteria: January 9, 2013
• First Posted (Estimate): January 10, 2013

Study Record Updates

• Last Update Posted (Estimate): January 10, 2013
• Last Update Submitted That Met QC Criteria: January 9, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Rasagiline; Apathy; Drug-naïve patients with Parkinson's disease
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Neuroprotective Agents; Protective Agents; Monoamine Oxidase Inhibitors; Rasagiline
• Other Study ID Numbers: CHU-0138; 2007-002800-16