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Non Motors Aspects in De Novo Parkinson's Disease

Phase 3
Conditions
Parkinson Disease
Apathy
Interventions
Drug: Placebo
Drug: Rotigotine
Registration Number
NCT02786667
Lead Sponsor
University Hospital, Grenoble
Brief Summary

Clinical description and pathophysiological study of recently diagnosed untreated patients with Parkinson's Disease.

Effect of a dopamine agonist (rotigotine) on apathy in de novo patients with Parkinson disease: A controlled, randomized, double blind study.

Detailed Description

This study aims to show the impact of a treatment with a D2/D3 receptor-specific dopamine agonist on the hypo-dopaminergic syndrome and quality of life of patients with de-novo Parkinson's disease.

The study consists of three parts:

1. The first part consists of a detailed clinical description of these patients, focusing on neuropsychological symptoms. The objective is to describe patients with and without apathy and hypo-dopaminergic syndrome.

2. From this population, a small number of patients with and without hypo-dopaminergic syndrome will be selected in order to compare serotoninergic and dopaminergic denervation by positron emission tomography (PET).

3. In patients with hypo-dopaminergic syndrome the motivational effects of a dopamine agonist will be tested in a randomized, double-blind, placebo-controlled study.

We hypothesize a significant improvement of apathy in the rotigotine group versus placebo

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
199
Inclusion Criteria
  • Patients with Parkinson disease without treatment for Parkinson disease
  • Recent diagnosis (< 2 years)
  • Without cognitive troubles
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Exclusion Criteria
  • Patients with cognitive troubles
  • Treated patients with L-Dopa or Dopamine agonists
  • Other severe illness
  • Pregnant or parturient woman
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlacebo6 months treatment with Placebo up to 8 mg per day with a titration period for one month
RotigotineRotigotine6 months treatment with Rotigotine up to 8 mg per day with a titration period for one month
Primary Outcome Measures
NameTimeMethod
Change of LARS (Lille Apathy Rating Scale) score in the rotigotine versus placebo group6 months
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University Hospital of Grenoble

🇫🇷

Grenoble, France

University Hospital of Grenoble
🇫🇷Grenoble, France
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