Non Motors Aspects in De Novo Parkinson's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02786667
• Date of registration: 18/05/2016
• Prospective Registration: No
• Primary sponsor: University Hospital, Grenoble
• Public title: Non Motors Aspects in De Novo Parkinson's Disease Honeymoon
• Scientific title: Non Motors Aspects in De Novo Parkinson's Disease: Clinical and Physiopathological Description; Dopamine Agonist Treatment Effects.
• Date of first enrolment: June 2012
• Target sample size: 199
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02786667
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Anna Castrioto, MD
• Affiliation: University Hospital, Grenoble

Key inclusion & exclusion 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



Age minimum: 30 Years
Age maximum: 72 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Apathy

Intervention(s)

Drug: Placebo

Drug: Rotigotine

Primary Outcome(s)

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

Secondary ID(s)

2011-002855-33

Source(s) of Monetary Support

Please refer to primary and secondary sponsors