Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced PD

This study is ongoing, but not recruiting participants.
Quintiles, Inc.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) ) Identifier:
First received: April 15, 2008
Last updated: January 8, 2016
Last verified: January 2016
The primary objective is to provide continued access to subjects who would like to continue levodopa-carbidopa intestinal gel (LCIG), after completion of an open-label study (S187.3.003 or S187.3.004).

Condition Intervention Phase
Advanced Parkinson's Disease
Drug: Levodopa-carbidopa intestinal gel
Device: CADD-Legacy® 1400 ambulatory infusion pump
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label Continuation Treatment Study With Levodopa - Carbidopa Intestinal Gel In Subjects With Advanced Parkinson's Disease And Severe Motor-Fluctuations Who Have Exhibited A Persistent And Positive Effect To Treatment In Previous Studies

Resource links provided by NLM:

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • The primary objective is continued access to LCIG treatment [ Time Frame: Up to 5 years after commercial availability ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary Objectives: To assess the long-term safety and tolerability of the LCIG therapeutic system, and to assess the maintenance of efficacy using data collected from US subjects [ Time Frame: Up to 5 years after commercial availability ] [ Designated as safety issue: Yes ]
    Evaluation of physical exams, neurological exams, vitals, ECGs, clinical lab assessments, concomitant medication usage, monitoring complications of the infusion device, adverse event monitoring, tolerability assessed by the number of subjects who complete the study. Maintenance of efficacy will be assessed by evaluating the mean change from baseline in the following: Off time, On time with troublesome dyskinesia and On time without troublesome dyskinesia as measured by the Parkinson's Disease Diary UPDRS total score, Parts I, II, III and IV scores, and dyskinesia item score PDQ-39 summary index and domain scores

Estimated Enrollment: 261
Study Start Date: November 2009
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: September 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Levodopa-carbidopa intestinal gel
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


Ages Eligible for Study:   30 Years to 99 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • The subject should have completed participation in Study S187.3.003 or S187.3.004; and, in the opinion of the Principal Investigator, would benefit from long-term treatment with LCIG. - For Canada, subjects will be allowed to participate in the S187.3.005 study with a minimum of 6 months of exposure to LCIG in the S187.3.004 study.
  • The subject must be able to understand the nature of the study and must provide written informed consent prior to the conduct of any study related procedures. If the subject does not have the capacity to provide informed consent, full informed consent must be obtained from the subject's legally authorized representative. Consenting will be performed according to local regulations.

Exclusion Criteria:

  • Medical, laboratory, psychiatric, or surgical issues deemed by the investigator to be clinically significant and which could interfere with the subjects participation in the study.
  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: NCT00660673

  Show 60 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Quintiles, Inc.
Study Director: Janet Benesh AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) ) Identifier: NCT00660673     History of Changes
Other Study ID Numbers: S187.3.005  2008-001329-33 
Study First Received: April 15, 2008
Last Updated: January 8, 2016
Health Authority: Portugal: National Pharmacy and Medicines Institute
Canada: Health Canada
Czech Republic: State Institute for Drug Control
United Kingdom: Medicines and Healthcare Products Regulatory Agency
New Zealand: Medsafe
Russia: Ministry of Health of the Russian Federation
Thailand: Ministry of Public Health
United States: Food and Drug Administration
Israel: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by AbbVie:
Severe Motor Fluctuations
levodopa/carbidopa intestinal gel
Parkinson's Disease

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 February 04, 2016