Honeymoon: Non Motors Aspects in De Novo Parkinson's Disease

Sponsor

University Hospital, Grenoble (Other)

Overall Status

Unknown status

CT.gov ID

NCT02786667

Collaborator

(none)

199

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease Apathy	Drug: Rotigotine Drug: Placebo	Phase 3

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:

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.
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).
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

Study Design

Study Type:

Interventional

Actual Enrollment :

199 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2012

Actual Primary Completion Date :

Oct 15, 2017

Anticipated Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rotigotine 6 months treatment with Rotigotine up to 8 mg per day with a titration period for one month	Drug: Rotigotine 6 months treatment with Rotigotine up to 8 mg per day with a titration period for one month Other Names: Neupro
Placebo Comparator: Placebo 6 months treatment with Placebo up to 8 mg per day with a titration period for one month	Drug: Placebo 6 months treatment with Placebo up to 8 mg per day with a titration period for one month

Arm

Intervention/Treatment

Experimental: Rotigotine

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

Drug: Rotigotine

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

Other Names:

Neupro

Placebo Comparator: Placebo

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

Drug: Placebo

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

Outcome Measures

Primary Outcome Measures

Change of LARS (Lille Apathy Rating Scale) score in the rotigotine versus placebo group [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 72 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Grenoble	Grenoble		France	38043

Sponsors and Collaborators

University Hospital, Grenoble

Investigators

Principal Investigator: Anna Castrioto, MD, University Hospital, Grenoble

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Grenoble

ClinicalTrials.gov Identifier:

NCT02786667

Other Study ID Numbers:

2011-002855-33

First Posted:

Jun 1, 2016

Last Update Posted:

Oct 26, 2017

Last Verified:

Oct 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Parkinson Disease

Rotigotine

Study Results

No Results Posted as of Oct 26, 2017