Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects

This study has been completed.

Sponsor:

Collaborator:

Quintiles

Information provided by (Responsible Party):

Abbott

ClinicalTrials.gov Identifier:

NCT00357994

First received: July 27, 2006

Last updated: November 16, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 27, 2006

Last Updated Date

November 16, 2012

Start Date ^ICMJE

January 2009

Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To evaluate a difference between levodopa-carbidopa intestinal gel and active control in the change from baseline and mean daily 'off' time (hours) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Efficacy will be assessed using the subject diary for “on”/”off” time and “on” time without troublesome dyskinesia, UPDRS, CGI-I, CGI-S

Change History

Complete list of historical versions of study NCT00357994 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To evaluate on time without troublesome dyskinesia, PDQ-39, UPDRS, caregiver burden [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

UPDRS, CGI-I, CGI-S

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects

Official Title ^ICMJE

A Randomized, Double-Blind, Double-Dummy, Efficacy, Safety and Tolerability Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects Receiving Optimized Treatments With Parkinson Medicinal Products Who Continue to Experience Persistent Motor Fluctuations

Brief Summary

The primary objective of this study will be to demonstrate the superiority of levodopa - carbidopa intestinal gel over treatment with optimized oral levodopa/carbidopa during 12 weeks.The study duration is 4 months.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Advanced Parkinson's Disease

Intervention ^ICMJE

Drug: Active levodopa carbidopa intestinal gel (LCIG)
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 per/hour)
Drug: Placebo 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)
Drug: Active Levodopa carbidopa (LC) oral encapsulated tablets
should be kept within a range of 0.5-10 mg/hour (10-200 mg levodopa/hour) and is usually (40-120 mg levodopa per/hour)
Drug: Placebo (PBO) levodopa-carbidopa (LC) oral capsules
Placebo (PBO) levodopa-carbidopa (LC) oral capsules
Device: CADD-Legacy® 1400 ambulatory infusion pump
CADD-Legacy® 1400 ambulatory infusion pump

Study Arm (s)

Experimental: 1
Levodopa carbidopa intestinal gel (LCIG)
Interventions:
- Drug: Active levodopa carbidopa intestinal gel (LCIG)
- Drug: Placebo (PBO) levodopa-carbidopa (LC) oral capsules
- Device: CADD-Legacy® 1400 ambulatory infusion pump
Active Comparator: 2
Levodopa-carbidopa (LC) oral encapsulated tablets
Interventions:
- Drug: Placebo gel
- Drug: Active Levodopa carbidopa (LC) oral encapsulated tablets

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 2011

Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria

Idiopathic Parkinson's disease (PD) according to United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria
levodopa responsive and subjects demonstrate some identifiable 'on response' established by observation by investigator
demonstrate severe motor fluctuations in spite of individually optimized treatment and where therapy options are indicated

Exclusion Criteria

Diagnosis is unclear or a suspicion of other parkinsonian syndromes exists such as secondary parkinsonism
undergone surgery for the treatment of PD
contraindications to levodopa
subjects with any neurological deficit that may interfere with the study assessments

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

Administrative Information

NCT Number ^ICMJE

NCT00357994

Other Study ID Numbers ^ICMJE

S187.3.001, 2006-000577-29

Has Data Monitoring Committee

Yes

Responsible Party

Abbott

Study Sponsor ^ICMJE

Abbott

Collaborators ^ICMJE

Quintiles

Investigators ^ICMJE

Study Director:

Janet Benesh

Abbott

Information Provided By

Abbott

Verification Date

November 2012

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

To Top