Parkinson´s disease
Conditions
Interventions
Trade Name: Comtess
Product Name: Comtess
Product Code: not applicable
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Entacapone
Concentration unit: mg milligram(s)
Trade Name: Dostinex
Sponsors
Orion Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -male and female patients suffering from idiopathic Parkinson's Disease (PD) with wearing-off phenomenon -age over 60 years -OFF-time per day over 60 min after the first ON-period in the morning -3-5 daily dosages of standard levodopa/DDC inhibitor -stable antiparkinsonian treatment 3 weeks prior to the randomisation -written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -symptomatic parkinsonism -concomitant treatment with non-selective MAO inhibitors or a selective MAO-A inhibitor while treated with a MAO-B inhibitor already -concomitant treatment with one of the following catechol-structured drugs: rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine or apomorphine -concomitant treatment with alpha-methyldopa, reserpine, typical or atypical neuroleptics, neuroleptic antiemetics (such as metoclo-pramide) or other drugs with antidopaminergic action -treatment with COMT-inhibitors or dopamine agonists 4 weeks prior to the randomisation -known hypersensitivity to ergot derivatives and entacapone -any clinically significant concurrent illness that may influence the outcome of the study or is contraindicatedtreatment with any investigational drug within the last 3 months prior to randomisation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Proof of one-sided equivalence in efficacy regarding the OFF-time (total h of awake time) 12 weeks after start of therapy;Secondary Objective: -comparison of the tolerability measured as adverse drug reactions in the course of the study -comparison of the UPDRS total score 12 weeks after start of therapy assessed by a blinded rater -comparison of the Dyskinesia score 12 weeks after start of therapy assessed by a blinded rater -comparison of the safety regarding physical examination, vital signs (including blood pressure supine and upright position) and laboratory parameters -comparison of clinical global evaluation performed by patient -comparison of ON-time -comparison of proportion of ON-time -comparison of daily levodopa doses and total amount of levodopacomparison of daily cabergoline/entacapone doses and total amount of cabergoline/entacapone;Primary end point(s): change in OFF-time (total h of awake time) recorded in a home diary | — |
Countries
Lithuania
Outcome results
None listed