Non Motors Aspects in De Novo Parkinson's Disease

Non Motors Aspects in De Novo Parkinson's Disease: Clinical and Physiopathological Description; Dopamine Agonist Treatment Effects.

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02786667

Acronym

Honeymoon

Enrollment

199

Registered

2016-06-01

Start date

2012-06-30

Completion date

2017-12-31

Last updated

2017-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apathy, Parkinson Disease

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

Interventions

DRUGRotigotine

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to 72 Years

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

Design outcomes

Primary

Measure	Time frame
Change of LARS (Lille Apathy Rating Scale) score in the rotigotine versus placebo group	6 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026