Safety/Efficacy Study of Levodopa-Carbidopa Intestinal Gel in Parkinson's Subjects

This study has been completed.

Sponsor:

Collaborator:

Quintiles

Information provided by (Responsible Party):

AbbVie ( AbbVie (prior sponsor, Abbott) )

ClinicalTrials.gov Identifier:

NCT00360568

First received: August 3, 2006

Last updated: January 2, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

August 3, 2006

Last Updated Date

January 2, 2013

Start Date ^ICMJE

June 2009

Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Long-term safety of LCIG over a 12-month period. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Safety data during long-term treatment

Change History

Complete list of historical versions of study NCT00360568 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Mean daily 'off' time (hours), UPDRS, CGI-I, PDQ 39 and EQ-5D [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Change from baseline in mean daily “off” time (hours), based on the three consecutive day average “off” time for the diary at endpoint.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety/Efficacy Study of Levodopa-Carbidopa Intestinal Gel in Parkinson's Subjects

Official Title ^ICMJE

Open-Label, 12-Month Safety and Efficacy Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Disease Subjects

Brief Summary

Long term safety and efficacy (12 months) of levodopa-carbidopa intestinal gel.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Dyskinesias
Parkinson's Disease
Severe Motor Fluctuations

Intervention ^ICMJE

Drug: 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);
Device: CADD-Legacy® 1400 ambulatory infusion pump
pump

Study Arm (s)

Experimental: 1

Levodopa-carbidopa intestinal gel

Interventions:

Drug: Levodopa-carbidopa intestinal gel
Device: CADD-Legacy® 1400 ambulatory infusion pump

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2012

Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria

idiopathic parkinson's disease (PD) according to UKPDS Brain Bank Criteria;
levodopa-responsive with severe motor fluctuations;
completion of protocol S187.3.001 or S187.3.002 and continue to meet the inclusion criteria for the preceding study

Exclusion Criteria

Patients with medically relevant abnormal findings (labs, ECG, physical examination, AEs, psychiatric, neurological or behavioral disorders, etc.) at end of the double-blind phase (week 12) of study S187.3.001 or S187.3.002

Gender

Both

Ages

30 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Germany, New Zealand

Administrative Information

NCT Number ^ICMJE

NCT00360568

Other Study ID Numbers ^ICMJE

S187.3.003, 2006-000578-53

Has Data Monitoring Committee

Yes

Responsible Party

AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Sponsor ^ICMJE

AbbVie (prior sponsor, Abbott)

Collaborators ^ICMJE

Quintiles

Investigators ^ICMJE

Study Director:

Janet Benesh

AbbVie

Information Provided By

AbbVie

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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