Efficacy and Safety Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Motor Fluctuations (PARPOC)
Drug: ODM-101 65mg Carbidopa
Drug: ODM-101 105mg Carbidopa
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Efficacy and Safety of ODM-101 Compared to a Standard Combination (Stalevo®); a Randomised, Double-blind, Crossover, Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Motor Fluctuations|
- Duration of off time [ Time Frame: Average per day (over 3 consecutive days during the last 2 weeks of each treatment period). ] [ Designated as safety issue: No ]Duration of off time measured by the diary will be analysed using analysis of variance (ANOVA) model for cross-over design.
- Unified Parkinson's disease rating Scale (UPDRS) I-IV and the sum of UPDRS II and III ('total score') [ Time Frame: Weeks 4, 8 and 12 ] [ Designated as safety issue: No ]UPDRS I-IV and the sum of UPDRS II and III ('total score') asses by the investigator analysed using ANOVA model for crossover design.
|Study Start Date:||May 2011|
|Study Completion Date:||September 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Stalevo
Experimental: ODM-101 65mg Carbidopa
|Drug: ODM-101 65mg Carbidopa|
Experimental: ODM-101 105mg Carbidopa
|Drug: ODM-101 105mg Carbidopa|
This is a randomised, double-blind, double-dummy, active-controlled, crossover, multicentre, phase II proof of concept study in patients with PD and end-of-dose motor fluctuations. The patient's individually optimised daily levodopa regimen must be kept stable for at least 2 weeks before randomisation. The patients will be randomised to receive ODM-101 with 65 mg of carbidopa, ODM-101 with 105 mg of carbidopa and Stalevo® according to a 3-period crossover design.
The study consists of a screening period, 3 treatment periods and a post-treatment period. For each patient,there will be 9 visits: a screening visit performed 7-28 days before randomisation, a randomisation visit (visit 1), 6 visits during the 3 treatment periods (i.e. 2, 4, 6, 8, 10 and 12 weeks after randomisation and the start of the study treatment; visits 2-7), and an end-of-study visit 7-21 days after the last visit of the last treatment period. The duration of study will be 14-23 weeks for each patient.
The patients switch to study drugs after all assessments have been done at visit 1. The strength of the levodopa in the study drug is determined by the patient's individually optimised levodopa regimen before randomisation. During the first 2 weeks of each treatment period, the patient's levodopa strength (but not frequency) in the study drug will be adjusted as necessary by the investigator. For the remaining 2 weeks of each treatment period, the levodopa strengths should be kept stable.
Unscheduled visits maybe performed during the first 2 weeks of each treatment period, if there is a need to adjust the levodopa strength. In case the patient has not contacted the study centre within a week after the start of the treatment period, the study personnel will phone the patient to ensure that the symptoms and possible adverse events (AEs) are sufficiently controlled and captured, and to assess the need to adjust the levodopa treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01766258
|Principal Investigator:||Claudia Trenkwalder, MD||Paracelsus-Elena-Klinik, Klinikstr. 16, 34128 Kassel, Germany|