Randomized Single-blind Placebo Controlled Comparative Trial of Pramipexole and Bromocriptine in Parkinson's Disease
The objective of the trial was to investigate the efficacy and safety of Pramipexole tablets in patients with Parkinson's disease (who can be treated with L-DOPA concomitantly) in a double-blind, comparative method using Bromocriptine tablets as comparators (phase III comparative trial).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Randomised Double-blind Comparative Trial of PPX Tablets and Bromocriptin Tablets in Patients With Parkinson`s Disease Who Are Concomitantly Treated With L-DOPA|
- Totalled score according to Part III of UPDRS (motor examination) Totalled score according to Part II of UPDRS (activities of daily living)
- Totalled score of UPDRS Part IV, UPDRS Part I, the Modified Hoehn and Yahr Staging, Parkinson Dyskinesia Scale, and patient records.
|Study Start Date:||July 2003|
|Estimated Study Completion Date:||August 2004|
The trial was to investigate the efficacy and safety of Pramipexole in patients with Parkinson's disease who can be concomitantly treated with L-DOPA in a double-blindmethod using Bromocriptine tablets as comparators (phase III comparative trial).
For efficacy evaluation, two primary endpoints were chosen:
- Totalled score according to Part III of UPDRS (motor examination)
- Totalled score according to Part II of UPDRS (activities of daily living)
The safety profile of the study drug was evaluated by physical examination, blood pressure, Electrocardiogram, Laboratory tests, AEs and SAEs.
Patients eligible for the trial who met all inclusion and exclusion criteria and who gave their informed consent were randomized to one of two treatment groups, i.e., Pramipexole tablets or Bromocriptine tablets. Patients were administered the study drug according to the dosing schedule.
The treatment period lasted maximal 12 weeks (ascending dose interval: up to 8 weeks, maintenance dose interval: 4 weeks or longer). In addition, a descending dose interval was 1-4 weeks.
Each patient received 7 visits except the patients drops or withdrawals:
visit 1: screening visit 2: randomization and baseline visit 3-6: ascending dose interval visit 7: Maintenance dose interval
Primary variables are both total of UPDRS (Unified Parkinson's Disease Rating Scale) part III items and of UPDRS part II items in change from baseline. The trial hypothesis is to demonstrate non-inferiority to Bromocriptine over an equivalence margin(=delta; the clinically largest difference judged as clinically acceptable) with 90% power, one sided for the above two primary variables at the error probability of 2.5% each. The equivalency margin for the primary variables (total of UPDRS Part III, and of UPDRS Part II) can be determined as 2.0 and 1.0 respectively referring to the results of oversea pivotal study of Pramipexole (BI Trial No. 248.326; U96-0232) and judged by the study investigator.
The primary endpoint of the study was the change of totalled score according to Part III of UPDRS (motor examination) and totalled score according to Part II of UPDRS (activities of daily living) after 12 weeks treatment of the study drug.
|Peking Union Medical College Hospital|
|Beijing, China, 100730|
|Beijing, China, 100730|
|General Hospital of PLA|
|Beijing, China, 100853|
|Beijing Tian Tan Hospital|
|Beijing, China, 100050|
|First Hospital of Beijing University|
|Beijing, China, 100034|
|Shanghai Rui Jin Hospital|
|Shanghai, China, 200025|
|Hua Shan Hospital, Fu Dan University|
|Shanghai, China, 200040|
|Study Chair:||Boehringer Ingelheim Study Coordinator||Boehringer Ingelheim Shanghai|