Non Motors Aspects in De Novo Parkinson's Disease (Honeymoon)

Grenoble Alpes University Hospital Center (CHU)

Status and phase: Unknown; Phase 3

Conditions: Apathy; Parkinson Disease

Treatments: Drug: Placebo; Drug: Rotigotine

Study type: Interventional

Funder types: Other

Identifiers

NCT02786667

2011-002855-33

Details and patient eligibility

About

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.

Full 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

Enrollment: 199 patients

Sex: All

Ages: 30 to 72 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with Parkinson disease without treatment for Parkinson disease
• Recent diagnosis (< 2 years)
• Without cognitive troubles

Exclusion criteria

• Patients with cognitive troubles
• Treated patients with L-Dopa or Dopamine agonists
• Other severe illness
• Pregnant or parturient woman

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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199 participants in 2 patient groups, including a placebo group

Rotigotine

Experimental group

Description:

6 months treatment with Rotigotine up to 8 mg per day with a titration period for one month

Treatment:

Drug: Rotigotine

Placebo

Placebo Comparator group

Description:

6 months treatment with Placebo up to 8 mg per day with a titration period for one month

Treatment:

Drug: Placebo