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
  Purpose

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.


Condition Intervention Phase
Advanced Parkinson's Disease
Drug: Active levodopa carbidopa intestinal gel (LCIG)
Drug: Placebo gel
Drug: Active Levodopa-carbidopa (LC) oral encapsulated tablets
Drug: Placebo (PBO) levodopa-carbidopa (LC) oral capsules
Device: CADD-Legacy® 1400 ambulatory infusion pump
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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 ]

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

Enrollment: 35
Study Start Date: December 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Levodopa carbidopa intestinal gel (LCIG)
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 (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
Active Comparator: 2
Levodopa-carbidopa (LC) oral encapsulated tablets
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)

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00660387

Locations
United States, Alabama
Site Reference ID/Investigator# 45931
Birmingham, Alabama, United States, 35222
United States, California
Site Reference ID/Investigator# 45910
Fountain Valley, California, United States, 92708
Site Reference ID/Investigator# 45925
Oceanside, California, United States, 92056
United States, Florida
Site Reference ID/Investigator# 45912
Port Charlotte, Florida, United States, 33890
United States, Illinois
Site Reference ID/Investigator# 45935
Chicago, Illinois, United States, 60611
United States, Kentucky
Site Reference ID/Investigator# 45930
Lexington, Kentucky, United States, 40536-0284
United States, New York
Site Reference ID/Investigator# 45934
New York, New York, United States, 10032
United States, North Carolina
Site Reference ID/Investigator# 45929
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Site Reference ID/Investigator# 45908
Cincinnati, Ohio, United States, 45267
Site Reference ID/Investigator# 45922
Cleveland, Ohio, United States, 44195-0001
United States, Washington
Site Reference ID/Investigator# 45915
Kirkland, Washington, United States, 98034
New Zealand
Site Reference ID/Investigator# 45904
Auckland, New Zealand, 1010
Site Reference ID/Investigator# 45902
Christchurch, New Zealand, 8011
Site Reference ID/Investigator# 45905
Hamilton, New Zealand, 3204
Sponsors and Collaborators
Abbott
Quintiles
Investigators
Study Director: Janet Benesh Abbott
  More Information

No publications provided by Abbott

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT00660387     History of Changes
Other Study ID Numbers: S187.3.002, 2007-003814-32
Study First Received: April 15, 2008
Last Updated: November 16, 2012
Health Authority: United States: Food and Drug Administration
New Zealand: Ministry of Health

Keywords provided by Abbott:
levodopa-carbidopa
Carbidopa
levodopa
dyskinesia
Duodopa
levodopa-carbidopa intestinal gel
Severe Motor Fluctuations
levodopa/carbidopa suspension

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Carbidopa
Carbidopa, levodopa drug combination
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Enzyme Inhibitors
Adjuvants, Immunologic
Immunologic Factors
Dopamine Agonists

ClinicalTrials.gov processed this record on September 16, 2014