Clinical trial NCT01765257: Evaluation of the Efficacy of Rasagiline in Apathy in Drug-naïve Patients With Parkinson's Disease by a Multi-center Study
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Drug-naïve Patients With Parkinson's Disease
Apathy
Keywords: Drug-naïve patients with Parkinson's disease
Apathy
Rasagiline
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: H. Lundbeck A/S
name: CHU Purpan (Toulouse)
name: Hôpital Haut-Lévêque
name: Centre Hospitalier de la côte Basque
name: Poitiers University Hospital
name: CHU de Rennes (Rennes)
name: University Hospital, Lille
name: Hôpital Dupuytren
name: University Hospital, Caen
name: Centre Hospitalier Universitaire de Nīmes
name: Centre Hospitalier du Pays d'Aix
name: Hôpital de la Timone (MARSEILLE)
name: University Hospital, Rouen
name: Centre Hospitalier Universitaire, Amiens
name: Centre Hospitalier Universitaire de Saint Etienne
name: Fondation Rothschild Paris
First posted: 2013-01-10
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Lille Apathy Rating Scale (LARS) score
timeFrame: at the visit 3 (after 3 months of treatment)
Secondary outcomes:
measure: Motor assessment : Unified Parkinson's Disease Rating Scale
timeFrame: at the visit 3 (after 3 months of treatment)
measure: Depressive and anxiety symptoms : MADRS + Hamilton anxiety scale
timeFrame: at the visit 3 (after 3 months of treatment)
measure: Self assessment of apathy : Starkstein
timeFrame: at the visit 3 (after 3 months of treatment)
measure: Quality of life : PDQ 39
timeFrame: at the visit 3 (after 3 months of treatment)
measure: Cognitive assessment: MATTIS dementia rating scale, MMSE, executive functions battery
timeFrame: at the visit 3 (after 3 months of treatment)
measure: Hyperdopaminergic symptoms : Parkinson's disease behavioral scale
timeFrame: at the visit 3 (after 3 months of treatment)
measure: Fatigue assessment : Parkinson Fatigue Scale
timeFrame: at the visit 3 (after 3 months of treatment)
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Denis PEZET
role: PRINCIPAL_INVESTIGATOR
References: