Parkinson's disease MedDRA version: 7.0 Level: LLT Classification code 10061536
Conditions
Sponsors
Orion Corporation, ORION PHARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female subjects • Aged 30 to 70 years, inclusive • A clinical diagnosis of idiopathic Parkinson’s disease (having at least 2 of the following three cardinal signs: resting tremor, bradykinesia, rigidity) with asymmetric symptom onset. • Modified Hoehn and Yahr stage 1.0 to 2.5 • Maximum disease duration of 5 years, based on diagnosis Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • History, signs or symptoms suggesting the diagnosis of atypical or secondary parkinsonism • Presence at baseline of drug-related wearing-off symptoms, dyskinesias or other motor complications, using questionnaire consistent with outcome assessment. • Previous or current levodopa or COMT inhibitor exposure. Current use of amantadine, or memantine and previous use at any time within 60 days prior to visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that Stalevo is superior to carbidopa/levodopa in time to onset of dyskinesias in Parkinson’s disease patients requiring initiation of levodopa treatment. ;Primary end point(s): Time to onset of dyskinesia;Secondary Objective: To test the following hypotheses: 1. StalevoTM provides symptom control comparable to or better than carbidopa/levodopa as measured by total score of UPDRS parts II plus III across the maintenance period. 2. StalevoTM is superior to carbidopa/levodopa with respect to the incidence of dyskinesia at 2 years of treatment. 3. StalevoTM is superior to carbidopa/levodopa with respect to the time elapsed before wearing off occurs. 4. Patients taking StalevoTM have a similar quality of life compared to those taking carbidopa/levodopa as measured by index score of PDQ-39 at 2 years of treatment. 5. The safety of StalevoTM and carbidopa/levodopa are similar across the double-blind treatment period. 6. Whether individual genetic variation in genes relating to drug metabolism, Parkinson’s disease, and the drug target pathway confer differential response to StalevoTM by performing explorative pharmacogenetic assessments. | — |
Countries
Finland, Italy, Sweden, United Kingdom
Outcome results
None listed