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Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson's Disease

This study has been completed.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) ) Identifier:
First received: June 8, 2006
Last updated: June 14, 2013
Last verified: June 2013

The primary objective of this study will be to provide further evidence of the long-term safety and tolerability of levodopa-carbidopa intestinal gel (Duodopa®) over 12-months in subjects with advanced Parkinson's Disease (PD) and severe motor-fluctuation

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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, 12-Month Safety and Efficacy Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Subjects With Advanced Parkinson's Disease and Severe Motor-Fluctuations Despite Optimized Treatment With Available Parkinson's Disease Medications

Resource links provided by NLM:

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Evaluation of orthostatic vitals signs, ECGs, and adverse event monitoring, 12 months clinical lab testing and physical exams [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    (Screening, NJ placement, PEG-J placement, then every 12 weeks for 12 months)

Secondary Outcome Measures:
  • Evaluation of ON versus OFF time using UPDRS, CGI-I, PDQ 39 and 12 months EQ-5D [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    assessment questionnaires (Screening, NJ placement, Day 28, day 84, Day 252 (CGI only), Day 387)

Enrollment: 349
Study Start Date: January 2008
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Levodopa Carbidopa Intestinal Gel (LCIG)
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 and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Idiopathic parkinson's disease(PD) according to UKPDS Brain Bank Criteria
  • Levodopa-responsive with severe motor fluctuations
  • Recognizable off and on state (motor fluctuations) confirmed by diary

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 (such as narrow angle glaucoma)
  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: NCT00335153

  Show 86 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Study Director: Janet Benesh AbbVie
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) ) Identifier: NCT00335153     History of Changes
Other Study ID Numbers: S187.3.004, 2006-005186-18
Study First Received: June 8, 2006
Last Updated: June 14, 2013
Health Authority: Russia: Ministry of Health of the Russian Federation
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Czech Republic: State Institute for Drug Control
Italy: The Italian Medicines Agency
Finland: Finnish Medicines Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
New Zealand: Medsafe
Poland: The Central Register of Clinical Trials
Portugal: National Pharmacy and Medicines Institute
Australia: Department of Health and Ageing Therapeutic Goods Administration
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Canada: Health Canada
Israel: Ministry of Health
Thailand: Ministry of Public Health

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 November 25, 2014