| Methods |
Randomised, double‐blind, parallel group design.
Randomisation by computer generated random numbers. Prospective stratification for high (> 600 mg) versus low (<600 mg) daily levodopa dose and whether or not other medication for PD was being taken.
Medication allocated consecutively in blocks of 4 in centres.
Location ‐ 9 centres in Austria, Germany and Switzerland.
Intention‐to‐treat analysis using last observation carried forward method.
Duration of therapy = 11 weeks. |
| Participants |
Pramipexole ‐ 34 patients with 5 drop outs (15%).
Placebo ‐ 44 patients with 6 drop outs (14%).
Details of terminations given.
Patients comparable for age, duration of disease and UPDRS total score at baseline. Note: higher frequency of women in pramipexole arm (41%) compared with placebo arm (30%).
Hoehn and Yahr scale comparable between arms at baseline.
Mean baseline levodopa dose: pramipexole arm = 538 (SD 314) mg/d; placebo arm = 593 (SD 264) mg/d. |
| Interventions |
Blind titration to maximum of 5 mg/d of pramipexole.
Titration phase < or = 7 weeks.
Maintenance = 4 weeks.
Dose reduction = 1 week.
Mean dose of pramipexole in active arm 3.59 mg/d.
NO change in levodopa dose allowed. |
| Outcomes |
Primary: UPDRS total score.
Secondary: UPDRS subscale scores.
Off time.
Schwab and England scale in on and off phase.
Dyskinesia scale ‐ details not given.
Clinicians global impression scale.
Adverse events. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
