At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 11 enrolled
Drug / intervention
TRIGEL +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single Centre, Two-period, Open Label, Randomised, Cross-over Study to Assess Plasma Levodopa, Carbidopa and Entacapone Concentrations After Continuous Infusion of TRIGEL or Duodopa in Patients With Advanced Parkinson´s Disease
In Brief
A Phase 1 clinical trial evaluating TRIGEL and Duodopa for Parkinson's Disease. Completed, enrolled 11 participants across 1 site.
Detailed Summary
This study evaluates the continuous addition of entacapone to infused levodopa and carbidopa on the pharmacokinetic (PK) profile in patients with advanced Parkinson's disease (PD). All patients will receive both study drugs, i.e. TRIGEL (levodopa, carbidopa, and entacapone) and Duodopa (levodopa and carbidopa), in randomized order.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson's Disease
CountriesSweden
CollaboratorsTFS Trial Form Support
Timeline
Phase 1CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartMay 2015
First PostedMay 2015
Primary CompletionJul 2015
TodayJul 2026
First PostedMay 20, 2015
Enrollment StartMay 1, 2015
Primary CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 11.1 years ago
Interventions
TRIGELdrug
All patients will receive TRIGEL. Treatment order is determined by randomization.
Duodopadrug
All patients will receive Duodopa. Treatment order is determined by randomization.