Rinne NOMECOMT 1998.

Methods	Randomised double‐blind parallel group study. Method of randomisation not described. 16 centres in Nordic countries. Intention‐to‐treat analysis. Duration: 6 months.
Participants	171 patients, 19 patients withdrew. 8 from entacapone group, 6 due to adverse events 2 due to other reasons. 11 withdrew from the placebo group, five due to adverse events, 6 due to other reasons. 47% male. Mean age 62.7, mean duration of PD 10.8 years, mean duration of fluctuations 4.5 years, mean levodopa dose 703 mg/day. Inclusion criteria: levodopa responsive patients with idiopathic PD with motor fluctuations of the end‐of‐dose type (wearing‐off phenomenon), Hoehn & Yahr stage 1.5‐4.0 during 'on' phase, and average 'on' time after each single dose of levodopa less than 4 hours. Patients taking 4‐10 daily doses of standard levodopa. Patients treated with amantadine, selegiline, or dopamine agonists in addition to levodopa were permitted. Exclusion criteria: Using controlled release levodopa preparations.
Interventions	Patients received 200 mg entacapone (n=85) or placebo (n=86) with each levodopa dose.
Outcomes	Primary outcomes: Daily 'on' time Duration of 'on' time after first morning levodopa dose. Secondary outcomes: Daily 'off' time Patients estimation of benefit from single levodopa dose UPDRS (all parts) ('on') Daily fluctuations in disability evaluation. Patient global score Clinician global score. Levodopa dose Levodopa dose frequency Adverse events
Notes	ENTACAPONE abstracts 'QOL' data combined with PSG 1997
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear