biostudies-literatureUnknown92(13)Trenkwalder COBJECTIVE:To investigate whether increased fixed carbidopa doses of 65 or 105 mg (ODM-101/65 and ODM-101/105) in combination with 75, 100, 125, or 150 mg of levodopa and 200 mg of entacapone might improve "off" time in fluctuating Parkinson disease (PD) compared to the standard combination of 4:1 levodopa/carbidopa with the usual 200 mg of entacapone (LCE) during a 4-week treatment period. METHODS:This was a randomized, double-blind, double-dummy, active-controlled, crossover, multicenter, phase II, proof-of-concept study in patients with fluctuating PD. RESULTS:One hundred seventeen patients were randomized into the study (mean age 67.0 years; daily "off" time 5.3 hours; mean daily levodopa dose 610 mg). Carryover-adjusted mean changes from baseline "off" times were during ODM-101/65, -1.Neurologye1487-e1496https://www.ebi.ac.uk/biostudies/studies/S-EPMC6453771biostudies-literatureIncreased dose of carbidopa with levodopa and entacapone improves "off" time in a randomized trial.PMC6453771Vahteristo MEllmen JTrenkwalder CKuoppamaki MMuller TfalseIncreased dose of carbidopa with levodopa and entacapone improves "off" time in a randomized trial.OBJECTIVE:To investigate whether increased fixed carbidopa doses of 65 or 105 mg (ODM-101/65 and ODM-101/105) in combination with 75, 100, 125, or 150 mg of levodopa and 200 mg of entacapone might improve "off" time in fluctuating Parkinson disease (PD) compared to the standard combination of 4:1 levodopa/carbidopa with the usual 200 mg of entacapone (LCE) during a 4-week treatment period. METHODS:This was a randomized, double-blind, double-dummy, active-controlled, crossover, multicenter, phase II, proof-of-concept study in patients with fluctuating PD. RESULTS:One hundred seventeen patients were randomized into the study (mean age 67.0 years; daily "off" time 5.3 hours; mean daily levodopa dose 610 mg). Carryover-adjusted mean changes from baseline "off" times were during ODM-101/65, -1.2019-01-01T00:00:00Z2019 Mar2025-04-04T23:59:36.007Z2019-06-06T22:54:47ZS-EPMC64537713082455910.1212/WNL.0000000000007173