Parkinson's disease Nervous System Diseases Parkinson's disease
Conditions
Interventions
Piribedil versus placebo
Sponsors
Institut de Recherches Internationales Servier (France)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Out-patients between 30 to 77 years old, with stage 1 to 3 (Hoehn and Yahr) and less than six weeks of previous L-dopa treatment, with less than 3 months of previous treatment by a dopaminergic agonist
Exclusion criteria
Exclusion criteria: 1. Patients frequently falling according to unified Parkinson's disease rating scale (UPDRS) II and/or III 2. Prior experience of a dopaminergic complication 3. Prior neurosurgery for PD 4. Previous history of freezing 5. Suspected autosomal juvenile Parkinsonism 6. Atypical Parkinsonian symtoms caused by drugs, metabolic disorders or encephalitis 7. History of psychotic symptoms 8. Poor cognitive performance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence and time to develop dyskinesia or other motor complications | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. UPDRS III 2. UPDRS II 3. Time to therapeutic failure 4. Percentage of patients requiring treatment with L-dopa 5. L-dopa daily dose 6. UPDRS IV 7. Other motor scores 8. Quality of life | — |
Countries
Argentina, France, India, Mexico, Portugal, South Africa, Spain
Outcome results
None listed