| Methods |
Randomised, double‐blind, parallel group design.
Randomisation by computer generated random numbers. Medication allocated consecutively in blocks of 4 in centres.
Location ‐ 26 North American centres.
Intention‐to‐treat analysis on 351 of the 360 patients randomised (see author's Table 1). I‐to‐T defined as those randomised who received one or more doses of study medication and for whom at least one post‐drug efficacy assessment was available.
Duration of therapy < or = 31 weeks. |
| Participants |
Pramipexole ‐ 181 patients with 30 drop outs (17%).
Placebo ‐ 179 patients with 39 drop outs (22%).
Details of terminations given.
Patients comparable for age, sex, duration of disease and severity of disease at baseline.
Mean Hoehn and Yahr scale in on phase at baseline 2.3 in both groups.
Mean baseline levodopa dose not given. |
| Interventions |
Blind titration to maximum of 1.5 mg tds of pramipexole.
Titration phase < or = 7 weeks.
Maintenance < or = 24 weeks.
Dose reduction = 1 week.
Mean dose of pramipexole in active arm not given.
Changes in levodopa dose allowed. |
| Outcomes |
Primary: UPDRS ADL (part II) as average of on and off scores and UPDRS motor (part III) in on phase only.
Secondary: UPDRS ADL on phase.
UPDRS ADL off phase.
UPDRS parts I and IV.
Off time.
Schwab and England scale in on and off phase.
Hoehn and Yahr in on and off phase.
Dyskinesia scale ‐ details not given.
Timed walking test.
Adverse events. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
