Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
199 participants
INTERVENTIONAL
2012-06-30
2017-12-31
Brief Summary
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Effect of a dopamine agonist (rotigotine) on apathy in de novo patients with Parkinson disease: A controlled, randomized, double blind study.
Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Rotigotine
6 months treatment with Rotigotine up to 8 mg per day with a titration period for one month
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
Placebo
6 months treatment with Placebo up to 8 mg per day with a titration period for one month
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Recent diagnosis (\< 2 years)
* Without cognitive troubles
Exclusion Criteria
* Treated patients with L-Dopa or Dopamine agonists
* Other severe illness
* Pregnant or parturient woman
30 Years
72 Years
ALL
No
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Anna Castrioto, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Locations
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University Hospital of Grenoble
Grenoble, , France
Countries
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Other Identifiers
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2011-002855-33
Identifier Type: -
Identifier Source: org_study_id