| Methods |
Randomised double‐blind parallel group study. The computer‐generated randomisation procedure was performed separately for each centre. Only the sponsor‐employed person who generated the plan was aware of a given individual's assignment during the study. The randomisation envelopes were printed in quadruplicate: one for the investigator, one for the monitor, one for the clinical research manager of the sponsor and one for the Safety Monitoring Committee.
Intention‐to‐treat analysis.
Multi‐centred, 30 centres in Germany & Austria.
Duration: 6 months |
| Participants |
301 patients, 63 patients withdrew. 15 withdrew from the placebo arm, 10 due to adverse events , 5 due to other reasons. 48 patients withdrew from the entacapone arm, 41 due to adverse events, 7 due to other reasons. 44% male. Mean age 61 years, mean duration of PD 8.9 years, mean levodopa dose 571 mg/day.
Inclusion criteria: levodopa responsive patients with idiopathic PD who needed enhancement and/or smoothening of levodopa effects; aged 30‐80 years; use 2‐10 daily doses of standard and/or CR levodopa preparations; stable levodopa treatment for 1 month before entering study.
Exclusion criteria: treatment with neuroleptics, neuroleptic antiemetics, catechol‐structured drugs, MAO‐A inhibitors or non‐selective MAO inhibitors. Patients with other major neurological, psychiatric or medical disorders. |
| Interventions |
Patients received 200 mg entacapone (n=197; 172 fluctuating) or placebo (n=104; 88 fluctuating) with each levodopa dose.
Patients treated with amantadine, memantine, anticholinergics, selegiline or dopamine agonists in addition to levodopa were allowed. |
| Outcomes |
UPDRS total (on)
levodopa dose
number of daily doses
'on' time
'off' time
Adverse effects
blood pressure
heart rate |
| Notes |
ENTACAPONE
Fluctuating & non‐fluctuating patients but results segregated. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
