A Phase 3 interventional study of Rotigotine and Placebo in Parkinson Disease and Apathy, sponsored by University Hospital, Grenoble. Status unknown at 1 site in France. Open to participants aged 30 Years to 72 Years. Per ClinicalTrials.gov, last updated 2017-10-26.
Sponsored by University Hospital, Grenoble · Phase 3, Interventional, and Treatment
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.
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:
We hypothesize a significant improvement of apathy in the rotigotine group versus placebo
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 199 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
6 months treatment with Rotigotine up to 8 mg per day with a titration period for one month
Drug: Rotigotine
6 months treatment with Placebo up to 8 mg per day with a titration period for one month
Drug: Placebo
6 months treatment with Rotigotine up to 8 mg per day with a titration period for one month
Also known as: Neupro
6 months treatment with Placebo up to 8 mg per day with a titration period for one month
Change of LARS (Lille Apathy Rating Scale) score in the rotigotine versus placebo group
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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University Hospital, Grenoble