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

January 8, 2013
January 9, 2013
June 2013
December 2014   (final data collection date for primary outcome measure)
Lille Apathy Rating Scale (LARS) score [ Time Frame: at the visit 3 (after 3 months of treatment) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01765257 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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 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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Drug-naïve Patients With Parkinson's Disease
  • Apathy
  • Drug: AZILECT®
  • Drug: Placebo
  • Experimental: rasagiline
    Randomized, double-blind, rasagiline (1 mg) vs placebo study. Parallel group (randomization 1/1). Duration 3 months 16 recruiting centers in France
    Intervention: 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
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
50
March 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
30 Years to 70 Years
No
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr
France
 
NCT01765257
CHU-0138, 2007-002800-16
Not Provided
University Hospital, Clermont-Ferrand
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
Principal Investigator: Denis PEZET University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP