Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by (Responsible Party):
Abbott Identifier:
First received: July 27, 2006
Last updated: November 16, 2012
Last verified: November 2012

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) [ 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: 36
Study Start Date: January 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 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
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)


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

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 identifier: NCT00357994

United States, California
Site Reference ID/Investigator# 45719
Los Angeles, California, United States, 90033
United States, Colorado
Site Reference ID/Investigator# 45718
Englewood, Colorado, United States, 80113
United States, District of Columbia
Site Reference ID/Investigator# 45722
Washington, District of Columbia, United States, 20007
United States, Florida
Site Reference ID/Investigator# 45721
Bradenton, Florida, United States, 34205
Site Reference ID/Investigator# 45705
Gainesville, Florida, United States, 32610
United States, Maryland
Site Reference ID/Investigator# 45740
Baltimore, Maryland, United States, 21201
United States, Missouri
Site Reference ID/Investigator# 45739
St. Louis, Missouri, United States, 63110
United States, Vermont
Site Reference ID/Investigator# 45703
Burlington, Vermont, United States, 05401
Site Reference ID/Investigator# 44970
Bochum, Germany, 44791
Site Reference ID/Investigator# 44971
Bremerhaven, Germany, 27574
Site Reference ID/Investigator# 44973
Dresden, Germany, 01307
Site Reference ID/Investigator# 44965
Hanover, Germany, 30625
Site Reference ID/Investigator# 44964
Kiel, Germany, 24105
Site Reference ID/Investigator# 44966
Marburg, Germany, 35033
Site Reference ID/Investigator# 44968
Tuebingen, Germany, 72076
Sponsors and Collaborators
Study Director: Janet Benesh Abbott
  More Information

No publications provided

Responsible Party: Abbott Identifier: NCT00357994     History of Changes
Other Study ID Numbers: S187.3.001, 2006-000577-29
Study First Received: July 27, 2006
Last Updated: November 16, 2012
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Carbidopa, levodopa drug combination
Adjuvants, Immunologic
Anti-Dyskinesia Agents
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Agonists
Enzyme Inhibitors
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on November 20, 2014