PSG 1996.
| Methods | G: unknown C: unknown Patients/doctors/assessors blind Not intention‐to‐treat | |
| Participants | USA 321 randomised 60 to 25 mg group, 67 to 50 mg group, 64 to 100 mg group, 64 to 200 mg group, 66 to placebo Incl: untreated idiopathic PD, H&Y I ‐ II, <7 yrs duration Excl: severe tremor, unstable medical or psychiatric problems, dementia Baseline mean UPDRS: 25 mg group 23; 50 mg group 23; 100 mg group 21; 200 mg group 21; placebo 20 | |
| Interventions | Treatment: lazabemide 12.5 / 25 / 50 / 100mg twice a day Control: placebo Duration of treatment: 52‐54 weeks | |
| Outcomes | Deaths UPDRS Levodopa requirement Total withdrawals | |
| Notes | FU: 56 weeks 2‐4 week washout | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No information provided. |
| Allocation concealment (selection bias) | Unclear risk | No information provided. |
| Blinding (performance bias and detection bias) Doctors, All outcomes | Low risk | Quote: “double‐blind” Quote: “All patients, investigators and co‐ordinating staff were kept unaware of treatment assignments.” |
| Blinding (performance bias and detection bias) Patients, All outcomes | Low risk | Quote: “matching tablets of placebo” |
| Blinding (performance bias and detection bias) Outcome assessors, All outcomes | Low risk | |
| Incomplete outcome data (attrition bias) Mortality | Unclear risk | Rx: 255 randomised, 224 (88%) analysed (16 withdrew because of side‐effects, 15 reasons for withdrawal not stated) C: 66 randomised, 54 (82%) analysed (three withdrew because of side‐effects, nine reasons for withdrawal not stated) |
| Incomplete outcome data (attrition bias) Parkinsonian impairment & disability | Unclear risk | Rx: 255 randomised, 253 analysed using last outcome carried forward analysis C: 66 randomised, 66 analysed using last outcome carried forward analysis |
| Incomplete outcome data (attrition bias) Participants requiring levodopa | Unclear risk | Rx: 255 randomised, 224 (88%) analysed (16 withdrew because of side‐effects, 15 reasons for withdrawal not stated) C: 66 randomised, 54 (82%) analysed (three withdrew because of side‐effects, nine reasons for withdrawal not stated) |
| Incomplete outcome data (attrition bias) Motor fluctuations & dyskinesias | Unclear risk | Outcome not assessed |
| Selective reporting (reporting bias) | Unclear risk | No protocol available. |
| Other bias | Unclear risk | Comment: Hoffmann‐ La Roche contributed to the authorship. |