Non Motors Aspects in De Novo Parkinson's Disease (Honeymoon)
Primary Purpose
Parkinson Disease, Apathy
Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Rotigotine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
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
Sites / Locations
- University Hospital of Grenoble
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Rotigotine
Placebo
Arm Description
6 months treatment with Rotigotine up to 8 mg per day with a titration period for one month
6 months treatment with Placebo up to 8 mg per day with a titration period for one month
Outcomes
Primary Outcome Measures
Change of LARS (Lille Apathy Rating Scale) score in the rotigotine versus placebo group
Secondary Outcome Measures
Full Information
NCT ID
NCT02786667
First Posted
May 18, 2016
Last Updated
October 25, 2017
Sponsor
University Hospital, Grenoble
1. Study Identification
Unique Protocol Identification Number
NCT02786667
Brief Title
Non Motors Aspects in De Novo Parkinson's Disease
Acronym
Honeymoon
Official Title
Non Motors Aspects in De Novo Parkinson's Disease: Clinical and Physiopathological Description; Dopamine Agonist Treatment Effects.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (Actual)
Primary Completion Date
October 15, 2017 (Actual)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
4. Oversight
Data Monitoring Committee
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Apathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
199 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rotigotine
Arm Type
Experimental
Arm Description
6 months treatment with Rotigotine up to 8 mg per day with a titration period for one month
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
6 months treatment with Placebo up to 8 mg per day with a titration period for one month
Intervention Type
Drug
Intervention Name(s)
Rotigotine
Other Intervention Name(s)
Neupro
Intervention Description
6 months treatment with Rotigotine up to 8 mg per day with a titration period for one month
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
6 months treatment with Placebo up to 8 mg per day with a titration period for one month
Primary Outcome Measure Information:
Title
Change of LARS (Lille Apathy Rating Scale) score in the rotigotine versus placebo group
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Castrioto, MD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Non Motors Aspects in De Novo Parkinson's Disease
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