Comparing Different Levodopa/Carbidopa/Entacapone Treatment Regimens (PARTEST)
The primary objective is to assess the effect of a single dose of two experimental levodopa/carbidopa/entacapone (L/C/E) treatment regimens versus standard L/C/E treatment regimen in Parkinson's disease (PD) patients with end-of-dose motor fluctuations in terms of duration of motor response after the first morning dose of levodopa. The secondary objective is to evaluate the safety of the L/C/E treatment regimens in patients with PD.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Duration of Motor Response After Administration of Experimental Levodopa/Carbidopa/Entacapone Treatment Regimens Compared to Standard Treatment (Stalevo®);a Randomised,Double-blind,Crossover,Multicentre,Single Dose Study in Patients With Parkinson?s Disease and Wearing-off Symptoms|
- Duration of motor response by UPDRS III [ Time Frame: 20 minute intervals ] [ Designated as safety issue: No ]Statistical method for the primary comparison will be analysis of variance (ANOVA) with the following grouping factors: treatment, sequence, subject, and period. Differences between Stalevo and treatment regimen A will be evaluated using orthogonal contrasts with 5% significance level.
|Study Start Date:||February 2011|
|Study Completion Date:||July 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Placebo||
This is a randomised, double-blind, 3-period crossover study comparing the effects of a single dose of two L/C/E treatment regimens (A and B) and standard L/C/E treatment regimen (Stalevo) on the duration of motor response in PD patients with wearing-off symptoms after the first morning dose of levodopa.
The study consists of a screening visit, 3 treatment visits and an end-of-study visit. Within 14 days of the screening visit, the patients will receive a single morning dose of study drug (either of the two L/C/E treatment regimens) or Stalevo. The order of the 3 treatment periods will be randomised according to a crossover design and the duration of each period is 2 days, followed by a wash-out period (1-9 days) during which the patients will be on their individual standard PD treatment.
Before each study day, patients will arrive at the study centre in the previous evening. The patients' own standard PD treatments will be discontinued at the latest by 22:00 to be continued after completion of the motor part (part III) of the Unified Parkinson's Disease Rating Scale (UPDRS III) next day. After completion of the UPDRS III, patients will return to their own standard PD treatments. Duration of the study will be 2 to 7 weeks per patient, depending on the length of the screening and wash-out periods.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01296464
|Hämeenlinna, Finland, 13530|
|ODL Terveys Oy (ODL)|
|Oulu, Finland, 90100|
|Pori, Finland, 28100|
|Länssjukhuset Ryhov, Medicin/Neurologmottagningen|
|Jönköping, Sweden, SE-55185|
|Karolinska Universitetssjukhuset Solna, Neurologkliniken|
|Stockholm, Sweden, SE-171 76|
|Principal Investigator:||Vilho Myllylä, Prof||Oulu Deaconess Instutute|