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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02786667
Recruitment Status : Unknown
Verified October 2017 by University Hospital, Grenoble.
Recruitment status was:  Active, not recruiting
First Posted : June 1, 2016
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Tracking Information
First Submitted Date  ICMJE May 18, 2016
First Posted Date  ICMJE June 1, 2016
Last Update Posted Date October 26, 2017
Actual Study Start Date  ICMJE June 2012
Actual Primary Completion Date October 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2016)
Change of LARS (Lille Apathy Rating Scale) score in the rotigotine versus placebo group [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Non Motors Aspects in De Novo Parkinson's Disease
Official Title  ICMJE Non Motors Aspects in De Novo Parkinson's Disease: Clinical and Physiopathological Description; Dopamine Agonist Treatment Effects.
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Parkinson Disease
  • Apathy
Intervention  ICMJE
  • Drug: Rotigotine
    6 months treatment with Rotigotine up to 8 mg per day with a titration period for one month
    Other Name: Neupro
  • Drug: Placebo
    6 months treatment with Placebo up to 8 mg per day with a titration period for one month
Study Arms  ICMJE
  • Experimental: Rotigotine
    6 months treatment with Rotigotine up to 8 mg per day with a titration period for one month
    Intervention: Drug: Rotigotine
  • Placebo Comparator: Placebo
    6 months treatment with Placebo up to 8 mg per day with a titration period for one month
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: October 25, 2017)
199
Original Estimated Enrollment  ICMJE
 (submitted: May 25, 2016)
52
Estimated Study Completion Date  ICMJE December 2017
Actual Primary Completion Date October 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 72 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02786667
Other Study ID Numbers  ICMJE 2011-002855-33
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Grenoble
Study Sponsor  ICMJE University Hospital, Grenoble
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anna Castrioto, MD University Hospital, Grenoble
PRS Account University Hospital, Grenoble
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP