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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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by University Hospital, Clermont-Ferrand
Sponsor:
Collaborators:
H. Lundbeck A/S, TEVA
CHU Purpan (Toulouse)
Hôpital Haut-Levêque (Pessac)
Centre Hospitalier de la Côte Basque
Centre Hospitalier Universitaire de Poitiers (Poitiers)
CHU de Rennes (Rennes)
University Hospital, Lille
CHU Dupuytren (Limoges)
University Hospital, Caen
Hôpital Caremeau (NIMES)
Centre Hospitalier Pays D'Aix
Hôpital de la Timone (MARSEILLE)
University Hospital, Rouen
Centre Hospitalier Universitaire, Amiens
Centre Hospitalier Universitaire de Saint Etienne
Fondation Rothschild Paris
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01765257
First received: January 8, 2013
Last updated: January 9, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Drug-naïve Patients With Parkinson's Disease
Apathy
Drug: AZILECT®
Drug: Placebo
Phase 4

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

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Lille Apathy Rating Scale (LARS) score [ Time Frame: at the visit 3 (after 3 months of treatment) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Motor assessment : Unified Parkinson's Disease Rating Scale [ Time Frame: at the visit 3 (after 3 months of treatment) ] [ Designated as safety issue: Yes ]
  • Depressive and anxiety symptoms : MADRS + Hamilton anxiety scale [ Time Frame: at the visit 3 (after 3 months of treatment) ] [ Designated as safety issue: Yes ]
  • Self assessment of apathy : Starkstein [ Time Frame: at the visit 3 (after 3 months of treatment) ] [ Designated as safety issue: Yes ]
  • Quality of life : PDQ 39 [ Time Frame: at the visit 3 (after 3 months of treatment) ] [ Designated as safety issue: Yes ]
  • Cognitive assessment: MATTIS dementia rating scale, MMSE, executive functions battery [ Time Frame: at the visit 3 (after 3 months of treatment) ] [ Designated as safety issue: Yes ]
  • Hyperdopaminergic symptoms : Parkinson's disease behavioral scale [ Time Frame: at the visit 3 (after 3 months of treatment) ] [ Designated as safety issue: Yes ]
  • Fatigue assessment : Parkinson Fatigue Scale [ Time Frame: at the visit 3 (after 3 months of treatment) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: June 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01765257

Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Not yet recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
H. Lundbeck A/S, TEVA
CHU Purpan (Toulouse)
Hôpital Haut-Levêque (Pessac)
Centre Hospitalier de la Côte Basque
Centre Hospitalier Universitaire de Poitiers (Poitiers)
CHU de Rennes (Rennes)
University Hospital, Lille
CHU Dupuytren (Limoges)
University Hospital, Caen
Hôpital Caremeau (NIMES)
Centre Hospitalier Pays D'Aix
Hôpital de la Timone (MARSEILLE)
University Hospital, Rouen
Centre Hospitalier Universitaire, Amiens
Centre Hospitalier Universitaire de Saint Etienne
Fondation Rothschild Paris
Investigators
Principal Investigator: Denis PEZET University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01765257     History of Changes
Other Study ID Numbers: CHU-0138, 2007-002800-16
Study First Received: January 8, 2013
Last Updated: January 9, 2013
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Drug-naïve patients with Parkinson's disease
Apathy
Rasagiline

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Rasagiline
Central Nervous System Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Monoamine Oxidase Inhibitors
Neuroprotective Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014