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

Apathy Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01765257
• Other study ID #: CHU-0138
• Secondary ID: 2007-002800-16
• Status: Not yet recruiting
• Phase: Phase 4
• First received: January 8, 2013
• Last updated: January 9, 2013
• Start date: June 2013
• Est. completion date: March 2015

Study information

• Verified date: January 2013
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• AZILECT®

• Placebo

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (17)

Lead Sponsor

Collaborator

University Hospital, Clermont-Ferrand

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lille Apathy Rating Scale (LARS) score		at the visit 3 (after 3 months of treatment)	Yes
Secondary	Motor assessment : Unified Parkinson's Disease Rating Scale		at the visit 3 (after 3 months of treatment)	Yes
Secondary	Depressive and anxiety symptoms : MADRS + Hamilton anxiety scale		at the visit 3 (after 3 months of treatment)	Yes
Secondary	Self assessment of apathy : Starkstein		at the visit 3 (after 3 months of treatment)	Yes
Secondary	Quality of life : PDQ 39		at the visit 3 (after 3 months of treatment)	Yes
Secondary	Cognitive assessment: MATTIS dementia rating scale, MMSE, executive functions battery		at the visit 3 (after 3 months of treatment)	Yes
Secondary	Hyperdopaminergic symptoms : Parkinson's disease behavioral scale		at the visit 3 (after 3 months of treatment)	Yes
Secondary	Fatigue assessment : Parkinson Fatigue Scale		at the visit 3 (after 3 months of treatment)	Yes