| Methods |
Randomised double‐blind parallel group study. The computer‐generated randomisation scheme included stratification (by centre) and blocking (block size = 4). Those randomised to recieve entacapone were further randomised to recieve either 24 or 26 weeks of active therapy followed respectively by either 4 or 2 weeks of placebo.
Multi‐centred, Finland.
Intention‐to‐treat analysis.
Duration: 24 weeks. |
| Participants |
205 patients, 23 patients withdrew. 10 patients in placebo group withdrew, 7 due to adverse events, 3 due to other reasons. 13 patients withdrew from the entacapone group, 7 due to adverse events and 6 due to other reasons. 64.9% male. Mean age 63.3 years. Disease duration 11.1 years. Mean years since motor fluctuations 4.4 years. Mean Modified Hoehn & Yahr stage 2.4 (SD 0.6). Mean levodopa dose 772 mg/day.
Inclusion criteria: Patients with idiopathic PD in (modified) Hoehn & Yahr stage 1.5 to 4 (when in an 'off' state), who were responsive to levodopa, who had motor fluctuations paralleling their levodopa dosing, and who were taking a stable regime of 4‐10 daily doses of carbidopa/levodopa.
Exclusion criteria: Patients with atypical or secondary parkinsonism, pronounced dementia, or other significant neurologic disease, major psychiatric disorders such as severe depression, or clinically severe or unstable systemic illness. Treated within 6 months with neuroleptic agents, or within one month with alpha‐methyldopa or reserpine. |
| Interventions |
Patients received 200 mg entacapone (n= 103) or placebo (n=102) with each levodopa dose. Patients were allowed to continue with amantadine, anticholinergics, selegiline or dopamine agonists at a constant dosage in addition to their levodopa doses. Patients were not allowed to receive controlled‐release formulations of carbidopa/levodopa. Concurrent treatment with catechol‐structured drugs was prohibited. |
| Outcomes |
Primary outcome: % 'on' time
Secondary outcomes: % 'on' time while awake in morning, afternoon, and evening
% asleep time
levodopa dose
number of levodopa dose failures
UPDRS total
UPDRS mental
UPDRS motor
UPDRS ADL
Global evaluation |
| Notes |
ENTACAPONE
abstracts 'QOL' data combined with Rinne & Nomecomt 1998 |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
