Non Motors Aspects in De Novo Parkinson's Disease

Parkinson Disease Clinical Trial

— Honeymoon  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02786667
• Other study ID #: 2011-002855-33
• Status: Active, not recruiting
• Phase: Phase 3
• First received: May 18, 2016
• Last updated: October 25, 2017
• Start date: June 2012
• Est. completion date: December 2017

Study information

• Verified date: October 2017
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 199
• Est. completion date: December 2017
• Est. primary completion date: October 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 72 Years

Eligibility

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

Related Conditions & MeSH terms

• Apathy
• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
France	University Hospital of Grenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

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