Brooks UK‐IRISH 2003.

Methods	Randomised double‐blind parallel group study. The patients were stratified into two groups fluctuators and non‐fluctuators and randomised in a 2:1 ratio to entacapone or placebo using a computerised method. Multi‐centred, UK and Ireland. Intention‐to‐treat analysis. Duration: 6 months
Participants	300 patients, 172 fluctuators, 128 non‐fluctuators. 49 receiving entacapone withdrew (24%), 38 due to adverse events, 16 receiving placebo withdrew (17%), 14 due to adverse events. In the fluctuating patients, 109 were male (63%), average age 65.3 years, average duration of PD 9.4 years, average levodopa dose 697 mg/day. Inclusion criteria: Patients aged 30‐80 years, with levodopa responsive idiopathic fluctuating or non‐fluctuating PD, who would benefit from levodopa enhancement. Number of levodopa doses could vary from 2‐10 daily.
Interventions	Patients received 200 mg entacapone (n=203) or placebo (n=97) with each levodopa dose. Both standard and controlled‐release levodopa preparations with either of the DDC inhibitors and any other concomitant antiparkinsonian medication were allowed.
Outcomes	'On' time UPDRS (all parts) Levodopa dose Adverse events
Notes	ENTACAPONE Fluctuating and non‐fluctuating patients but the data is segregated.
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate