Randomized Single-blind Placebo Controlled Comparative Trial of Pramipexole and Bromocriptine in Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study 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
      single blind, comparative method using Bromocriptine tablets as comparators (phase III
      comparative trial)
    

Detailed description: 
      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

      Study Hypothesis:

      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.

      Comparison(s):

      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.
    

Intervention name(s): Pramipexole; Bromocriptine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Pramipexole; Bromocriptine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment