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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01765257
First Posted: January 10, 2013
Last Update Posted: January 10, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
H. Lundbeck A/S, TEVA
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
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
January 8, 2013
January 10, 2013
January 10, 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) ]
Same as current
No Changes Posted
  • Motor assessment : Unified Parkinson's Disease Rating Scale [ Time Frame: at the visit 3 (after 3 months of treatment) ]
  • Depressive and anxiety symptoms : MADRS + Hamilton anxiety scale [ Time Frame: at the visit 3 (after 3 months of treatment) ]
  • Self assessment of apathy : Starkstein [ Time Frame: at the visit 3 (after 3 months of treatment) ]
  • Quality of life : PDQ 39 [ Time Frame: at the visit 3 (after 3 months of treatment) ]
  • Cognitive assessment: MATTIS dementia rating scale, MMSE, executive functions battery [ Time Frame: at the visit 3 (after 3 months of treatment) ]
  • Hyperdopaminergic symptoms : Parkinson's disease behavioral scale [ Time Frame: at the visit 3 (after 3 months of treatment) ]
  • Fatigue assessment : Parkinson Fatigue Scale [ Time Frame: at the visit 3 (after 3 months of treatment) ]
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
 
Unknown status
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
Sexes Eligible for Study: All
30 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01765257
CHU-0138
2007-002800-16
Not Provided
Not Provided
Not Provided
University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
  • H. Lundbeck A/S, TEVA
  • 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
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