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CompletedNCT01484990Updated Nov 21, 2017

A Pharmacokinetic Study of Levodopa and Carbidopa Intestinal Gel in Subjects With Advanced Parkinson's Disease

A Phase 1 interventional study of Levodopa-Carbidopa in Parkinson Disease, sponsored by AbbVie. Completed. Open to participants aged 30 Years to 99 Years. Per ClinicalTrials.gov, last updated 2017-11-21.

Sponsored by AbbVie · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
19
Allocation
Not applicable
Ages
30 Years to 99 Years
Sex
All
01

Study summary

A Pharmacokinetic Study of Levodopa and Carbidopa Intestinal Gel in Subjects with Advanced Parkinson's Disease.

02

Conditions studied

  • Parkinson Disease

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Keywords

  • Parkinson's Disease
  • levodopa
  • carbidopa
  • Duodopa
  • intestinal gel
03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 19 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.

Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male or female subjects at least 30 years old;
  2. Subjects with advanced Parkinson's disease who are already on LCIG (Duodopa®) for at least 30 days;
  3. Body mass index range from 18.0 to 30.0 kg/m2

Exclusion criteria

Exclusion Criteria

  1. Subjects who are considered to be violent or subjects considered at suicidal risk by the investigator;
  2. Clinically significant abnormal laboratory data at baseline or any abnormal laboratory value that could interfere with the study assessments;
  3. 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
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    1

    Drug: Levodopa-Carbidopa

Interventions

  • DrugLevodopa-Carbidopa

    Intestinal Gel

06

What researchers measure

Primary outcomes

  1. Profile of Pharmacokinetics

    Levodopa, Carbidopa and Metabolite:Cmax, Cmin, Area Under Curve, T max, half life, peak-trough fluctuation.

    Time frame: 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.

  2. 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)

    Time frame: 2 days

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 23229334 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01484990
Lead sponsor
AbbVie
Collaborators
Quintiles, Inc.
Responsible party
Sponsor
First posted
Dec 5, 2011
Start date
Apr 2010
Primary completion
Sep 2010
Completion
Sep 2010
Last update
Nov 21, 2017

Study contacts

Janet Benesh
study director · Abbott

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.

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