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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

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:

  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

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Study Type : Interventional  (Clinical Trial)
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 : June 2012
Actual Primary Completion Date : October 15, 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Rotigotine

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 Name: 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




Primary Outcome Measures :
  1. Change of LARS (Lille Apathy Rating Scale) score in the rotigotine versus placebo group [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 72 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02786667


Locations
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France
University Hospital of Grenoble
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Anna Castrioto, MD University Hospital, Grenoble
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02786667    
Other Study ID Numbers: 2011-002855-33
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Rotigotine
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs