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:
NCT00660387
First received: April 15, 2008
Last updated: November 16, 2012
Last verified: November 2012

April 15, 2008
November 16, 2012
December 2009
October 2011   (final data collection date for primary outcome measure)
To evaluate a difference between levodopa-carbidopa intestinal gel and active control in the change from baseline and mean daily 'off' time (hours) at Week 12 (endpoint) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
To evaluate a difference between levodopa-carbidopa intestinal gel and active control in the change from baseline and mean daily "off" time (hours) at Week 12 (endpoint) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00660387 on ClinicalTrials.gov Archive Site
To evaluate on time without troublesome dyskinesia, PDQ-39, UPDRS, caregiver burden [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Advanced Parkinson's Disease
  • 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/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
  • 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
Olanow CW, Kieburtz K, Odin P, Espay AJ, Standaert DG, Fernandez HH, Vanagunas A, Othman AA, Widnell KL, Robieson WZ, Pritchett Y, Chatamra K, Benesh J, Lenz RA, Antonini A; LCIG Horizon Study Group. Continuous intrajejunal infusion of levodopa-carbidopa intestinal gel for patients with advanced Parkinson's disease: a randomised, controlled, double-blind, double-dummy study. Lancet Neurol. 2014 Feb;13(2):141-9. doi: 10.1016/S1474-4422(13)70293-X. Epub 2013 Dec 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   New Zealand
 
NCT00660387
S187.3.002, 2007-003814-32
Yes
Abbott
Abbott
Quintiles
Study Director: Janet Benesh Abbott
Abbott
November 2012

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