A Pharmacokinetic Study of Levodopa and Carbidopa Intestinal Gel in Subjects With Advanced Parkinson's Disease
2 other identifiers
interventional
19
0 countries
N/A
Brief Summary
A Pharmacokinetic Study of Levodopa and Carbidopa Intestinal Gel in Subjects with Advanced Parkinson's Disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 parkinson-disease
Started Apr 2010
Shorter than P25 for phase_1 parkinson-disease
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 28, 2011
CompletedFirst Posted
Study publicly available on registry
December 5, 2011
CompletedNovember 21, 2017
November 1, 2011
5 months
July 28, 2011
November 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Profile of Pharmacokinetics
Levodopa, Carbidopa and Metabolite:Cmax, Cmin, Area Under Curve, T max, half life, peak-trough fluctuation.
5mins, then every 30 minutes up to 8 hours (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8 hour), 12, 16 (immediately after flushing the tube), 17, 18, and 19 hours.
Safety and Tolerability Data Assessments (e.g., clinical laboratory tests, orthostatic vitals, adverse events assessment, physical exam)
Evaluation of orthostatic vitals signs, ECGs, and adverse event monitoring (Screening, Day -1, Day 1, Day 2), clinical lab testing and physical exam (Screening and Day 2)
2 days
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Male or female subjects at least 30 years old;
- Subjects with advanced Parkinson's disease who are already on LCIG (Duodopa®) for at least 30 days;
- Body mass index range from 18.0 to 30.0 kg/m2
You may not qualify if:
- Subjects who are considered to be violent or subjects considered at suicidal risk by the investigator;
- Clinically significant abnormal laboratory data at baseline or any abnormal laboratory value that could interfere with the study assessments;
- Subjects with serious symptomatic cerebral disease, cerebrovascular disease, focal neurological lesions (previous brain surgery), any acute brain trauma requiring treatment with anticonvulsant therapy, or acute stroke
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
- Quintiles, Inc.collaborator
Related Publications (1)
Nyholm D, Odin P, Johansson A, Chatamra K, Locke C, Dutta S, Othman AA. Pharmacokinetics of levodopa, carbidopa, and 3-O-methyldopa following 16-hour jejunal infusion of levodopa-carbidopa intestinal gel in advanced Parkinson's disease patients. AAPS J. 2013 Apr;15(2):316-23. doi: 10.1208/s12248-012-9439-1. Epub 2012 Dec 11.
PMID: 23229334RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janet Benesh
Abbott
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2011
First Posted
December 5, 2011
Study Start
April 1, 2010
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
November 21, 2017
Record last verified: 2011-11