Overview

This trial is active, not recruiting.

Condition advanced parkinson's disease
Treatments levodopa-carbidopa intestinal gel, cadd-legacy® 1400 ambulatory infusion pump
Phase phase 3
Sponsor AbbVie (prior sponsor, Abbott)
Collaborator Quintiles, Inc.
Start date November 2009
End date September 2020
Trial size 261 participants
Trial identifier NCT00660673, 2008-001329-33, S187.3.005

Summary

The primary objective is to provide continued access to subjects who would like to continue levodopa-carbidopa intestinal gel (LCIG), after completion of an open-label study (S187.3.003 or S187.3.004).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Levodopa-carbidopa intestinal gel
levodopa-carbidopa intestinal gel
should be kept within a range of 0.5-10 ml/hour (10-200 mg levodopa/hour) and is usually 2-6 ml/hour (40-120 mg levodopa/hour);
cadd-legacy® 1400 ambulatory infusion pump
pump

Primary Outcomes

Measure
Adverse Events
time frame: Approximately 10 years, dependent on commercial availability of levodopa-carbidopa intestinal gel in each country

Secondary Outcomes

Measure
Long Term Safety and Maintenance of Efficacy
time frame: Approximately 10 years, dependent on commercial availability of levodopa-carbidopa intestinal gel in each country

Eligibility Criteria

Male or female participants from 30 years up to 99 years old.

Inclusion Criteria: - The subject should have completed participation in Study S187.3.003 or S187.3.004; and, in the opinion of the Principal Investigator, would benefit from long-term treatment with LCIG. - For Canada, subjects will be allowed to participate in the S187.3.005 study with a minimum of 6 months of exposure to LCIG in the S187.3.004 study. - The subject must be able to understand the nature of the study and must provide written informed consent prior to the conduct of any study related procedures. If the subject does not have the capacity to provide informed consent, full informed consent must be obtained from the subject's legally authorized representative. Consenting will be performed according to local regulations. Exclusion Criteria: - Medical, laboratory, psychiatric, or surgical issues deemed by the investigator to be clinically significant and which could interfere with the subjects participation in the study.

Additional Information

Official title Open-Label Continuation Treatment Study With Levodopa - Carbidopa Intestinal Gel In Subjects With Advanced Parkinson's Disease And Severe Motor-Fluctuations Who Have Exhibited A Persistent And Positive Effect To Treatment In Previous Studies
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by AbbVie.