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Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's Disease

NCT00660673 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 262

Last updated 2022-12-02

Study results available
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Summary

The primary objective of this study is to provide continued access to levodopa-carbidopa intestinal gel (LCIG), to participants who have already participated in an open-label efficacy and safety study with the same treatment (Study S187.3.003 \[NCT00360568\] or Study S187.3.004 \[NCT00335153\]).

Conditions

  • Advanced Parkinson's Disease

Interventions

DRUG

Levodopa-Carbidopa Intestinal Gel (LCIG)

LCIG for upper-intestinal infusion is a suspension of levodopa (20 mg/mL) and carbidopa (5 mg/mL) in an aqueous gel that is dispensed in a medication cassette reservoir containing 100 mL of LCIG.

DEVICE

CADD-Legacy® 1400 ambulatory infusion pump

Portable infusion pump (CADD-Legacy Pump Model 1400) connected to the LCIG medication cassette reservoir.

DEVICE

Percutaneous Endoscopic Gastrostomy with jejunal extension tube (PEG-J)

All participants previously had a PEG-J placed in one of the prior LCIG studies.

Sponsors & Collaborators

  • IQVIA, formerly Quintiles

    collaborator UNKNOWN

  • AbbVie

    lead INDUSTRY

Principal Investigators

  • ABBVIE INC. · AbbVie

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
99 Years
Sex
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-13
Primary Completion
2021-11-30
Completion
2021-11-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Czechia
  • Israel
  • New Zealand
  • Poland
  • Portugal
  • Russia
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

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 NCT00660673 on ClinicalTrials.gov