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Safety/Efficacy Study of Levodopa-Carbidopa Intestinal Gel in Parkinson's Subjects

This study has been completed.
Sponsor:
Collaborator:
Quintiles
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00360568
First received: August 3, 2006
Last updated: January 2, 2013
Last verified: January 2013
History of Changes
  Purpose

Long term safety and efficacy (12 months) of levodopa-carbidopa intestinal gel.


Condition Intervention Phase
Dyskinesias
Parkinson's Disease
Severe Motor Fluctuations
 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: Open-Label, 12-Month Safety and Efficacy Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Disease Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Long-term safety of LCIG over a 12-month period. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mean daily 'off' time (hours), UPDRS, CGI-I, PDQ 39 and EQ-5D [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: June 2009
Study Completion Date: October 2012
Primary Completion Date: October 2012 (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
pump

  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 UKPDS Brain Bank Criteria;
  • levodopa-responsive with severe motor fluctuations;
  • completion of protocol S187.3.001 or S187.3.002 and continue to meet the inclusion criteria for the preceding study

Exclusion Criteria

  • Patients with medically relevant abnormal findings (labs, ECG, physical examination, AEs, psychiatric, neurological or behavioral disorders, etc.) at end of the double-blind phase (week 12) of study S187.3.001 or S187.3.002
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00360568

Locations
United States, Alabama
Site Reference ID/Investigator# 45869
Birmingham, Alabama, United States, 35222
United States, California
Site Reference ID/Investigator# 45834
Fountain Valley, California, United States, 92708
Site Reference ID/Investigator# 45854
Los Angeles, California, United States, 90033
Site Reference ID/Investigator# 45856
Oceanside, California, United States, 92056
United States, District of Columbia
Site Reference ID/Investigator# 45859
Washington, District of Columbia, United States, 20007
United States, Florida
Site Reference ID/Investigator# 45857
Bradenton, Florida, United States, 34205
Site Reference ID/Investigator# 45863
Gainesville, Florida, United States, 32610
Site Reference ID/Investigator# 45836
Port Charlotte, Florida, United States, 33890
United States, Illinois
Site Reference ID/Investigator# 45874
Chicago, Illinois, United States, 60611
United States, Kentucky
Site Reference ID/Investigator# 45868
Lexington, Kentucky, United States, 40536-0284
United States, Maryland
Site Reference ID/Investigator# 45862
Baltimore, Maryland, United States, 21201
United States, Missouri
Site Reference ID/Investigator# 45861
St. Louis, Missouri, United States, 63110
United States, New York
Site Reference ID/Investigator# 45873
New York, New York, United States, 10032
United States, Ohio
Site Reference ID/Investigator# 45878
Cincinnati, Ohio, United States, 45267
Site Reference ID/Investigator# 45850
Cleveland, Ohio, United States, 44195-0001
United States, Vermont
Site Reference ID/Investigator# 45887
Burlington, Vermont, United States, 05401
Germany
Site Reference ID/Investigator# 45828
Bochum, Germany, 44791
Site Reference ID/Investigator# 45829
Bremerhaven, Germany, 27574
Site Reference ID/Investigator# 45825
Hanover, Germany, 30625
Site Reference ID/Investigator# 54402
Tuebingen, Germany, 72076
New Zealand
Site Reference ID/Investigator# 45884
Auckland, New Zealand, 1010
Site Reference ID/Investigator# 45885
Hamilton, New Zealand, 3204
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Quintiles
Investigators
Study Director: Janet Benesh AbbVie
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT00360568     History of Changes
Other Study ID Numbers: S187.3.003, 2006-000578-53
Study First Received: August 3, 2006
Last Updated: January 2, 2013
Health Authority: United States: Food and Drug Administration
New Zealand: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AbbVie:
carbidopa
severe motor fluctuations
intestinal gel
levodopa
efficacy
 levodopa carbidopa intestinal gel
dyskinesia
Parkinson's Disease
Duodopa
levodopa-carbidopa

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

ClinicalTrials.gov processed this record on May 16, 2013