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A Study to Compare Plasma Levels of Levodopa, Carbidopa and Entacapone After TRIGEL or Duodopa Infusion in PD Patients

NCT02448914 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2016-05-23

Study results available
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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.

Conditions

Interventions

DRUG

TRIGEL

All patients will receive TRIGEL. Treatment order is determined by randomization.

DRUG

Duodopa

All patients will receive Duodopa. Treatment order is determined by randomization.

Sponsors & Collaborators

  • TFS Trial Form Support

    collaborator INDUSTRY

  • LobSor Pharmaceuticals AB

    lead INDUSTRY

Principal Investigators

  • Dag Nyholm, Assoc. Prof. · Department of Neuroscience, Neurology, Uppsala University Hospital, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02448914 on ClinicalTrials.gov