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A Study to Assess the Safety and Efficacy of Levodopa Carbidopa Intestinal Gel for the Treatment of Non-motor Symptoms in Subjects With Advanced Parkinson's Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01736176
First received: November 27, 2012
Last updated: November 11, 2014
Last verified: November 2014
  Purpose

The primary objective of this study is to evaluate change in non-motor symptoms from baseline to Week 12 as measured by the Non-Motor Symptom Scale total score.


Condition Intervention Phase
Advanced Parkinson's Disease
Drug: Levodopa-Carbidopa Intestinal Gel
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Two Part, Multicenter Study to Assess the Safety and Efficacy of Levodopa Carbidopa Intestinal Gel (LCIG) for the Treatment of Non-Motor Symptoms in Subjects With Advanced Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • To assess changes in non-motor symptoms using Non-Motor Symptom Scale [ Time Frame: Baseline compared to Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of subjects who use health resources [ Time Frame: Baseline compared to Week 4 ] [ Designated as safety issue: Yes ]
    Collect use of health resources (emergency room, doctors, urgent care, hospitals) with the Health Resource Utilization Questionnaire

  • Number of subjects who have Adverse Events [ Time Frame: Baseline compared to \ Week 60 ] [ Designated as safety issue: Yes ]
    Collect number and type of safety events with adverse event collection, vitals, and labs

  • To assess changes in non-motor symptoms using Non-Motor Symptom Scale [ Time Frame: Baseline compared to Week 60 ] [ Designated as safety issue: No ]
  • To assess changes in motor symptoms using United Parkinson's Disease Rating Scale [ Time Frame: Baseline compared to Week 60 ] [ Designated as safety issue: No ]
  • To assess improvements in cognition using neurocognition assessments: Spatial Working Memory [ Time Frame: Baseline compared to Week 12 ] [ Designated as safety issue: No ]
  • To assess changes in quality of life through: Parkinson's Disease Questionnaire-39 Item [ Time Frame: Baseline to Week 60 ] [ Designated as safety issue: No ]
  • To assess changes in quality of life through: Patient Global Impression of Change [ Time Frame: Baseline to Week 60 ] [ Designated as safety issue: No ]
  • To assess changes in quality of life through: Treatment Satisfaction Question [ Time Frame: Baseline to Week 60 ] [ Designated as safety issue: No ]
  • To assess changes in quality of life through: Health-Related Productivity Questionnaire [ Time Frame: Baseline to Week 60 ] [ Designated as safety issue: No ]
  • To assess changes in motor symptoms using Parkinson's Disease Diary [ Time Frame: Baseline compared to Week 60 ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: March 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Levodopa-Carbidopa Intestinal Gel
Single Arm, open label: Levodopa-Carbidopa Intestinal Gel
Drug: Levodopa-Carbidopa Intestinal Gel
Dose levels will be individually optimized. 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).

  Eligibility

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

Inclusion Criteria:

  • Subject must have a diagnosis of idiopathic Parkinson's disease according to the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria
  • Demonstrate persistent motor fluctuations in spite of individually optimized treatment
  • Subject must experience a minimum of 3 hours "Off" time

Exclusion Criteria:

  • Subject's PD diagnosis is unclear or there is a suspicion that the subject has a Parkinsonian syndrome such as secondary Parkinsonism (e.g., caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), Parkinson-plus syndrome (e.g., Multiple System Atrophy, Progressive Supranuclear Palsy, Diffuse Lewy Body Disease, Corticobasilar Degeneration), or other neurodegenerative disease that might mimic the symptoms of PD.
  • Subject has undergone neurosurgery for the treatment of Parkinson's disease
  • Subject for whom the placement of a PEG-J tube for LCIG treatment is contraindicated or is considered a high risk for the PEG-J procedure according to the gastroenterology evaluation (e.g., pathological changes of the gastric wall, inability to bring the gastric wall and abdominal wall together, blood coagulation disorders, peritonitis, acute pancreatitis, paralytic ileus).
  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: NCT01736176

Contacts
Contact: Brenda A Andrade, BS brenda.andrade@abbvie.com
Contact: Michelle S Brueck, BS michelle.brueck@abbvie.com

Locations
United States, Alabama
Site Reference ID/Investigator# 85176 Active, not recruiting
Birmingham, Alabama, United States, 35294-0021
United States, California
Site Reference ID/Investigator# 66684 Active, not recruiting
Encinitas, California, United States, 92024
United States, Florida
Site Reference ID/Investigator# 103155 Active, not recruiting
Boca Raton, Florida, United States, 33486
Site Reference ID/Investigator# 82634 Active, not recruiting
Gainesville, Florida, United States, 32607
United States, Georgia
Site Reference ID/Investigator# 122915 Recruiting
Atlanta, Georgia, United States, 30329
Principal Investigator: Site Reference ID/Investigator# 122915         
United States, Illinois
Site Reference ID/Investigator# 112857 Active, not recruiting
Winfield, Illinois, United States, 60190
United States, Kansas
Site Reference ID/Investigator# 103156 Completed
Kansas City, Kansas, United States, 66160
United States, Kentucky
Site Reference ID/Investigator# 66682 Active, not recruiting
Lexington, Kentucky, United States, 40536
United States, Michigan
Site Reference ID/Investigator# 110115 Active, not recruiting
West Bloomfield, Michigan, United States, 48322
United States, Ohio
Site Reference ID/Investigator# 82635 Active, not recruiting
Cincinnati, Ohio, United States, 45219
Site Reference ID/Investigator# 84453 Active, not recruiting
Cleveland, Ohio, United States, 44195-0001
United States, Washington
Site Reference ID/Investigator# 89193 Active, not recruiting
Kirkland, Washington, United States, 98034
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Janet Benesh, BS AbbVie
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01736176     History of Changes
Other Study ID Numbers: M12-920
Study First Received: November 27, 2012
Last Updated: November 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AbbVie:
carbidopa
levodopa
Advanced Parkinson's disease
Safety and efficacy
levodopa-carbidopa intestinal gel,
Non-Motor Symptom Scale

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
Carbidopa, levodopa drug combination
Levodopa
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

ClinicalTrials.gov processed this record on November 20, 2014