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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01736176
First received: November 27, 2012
Last updated: January 8, 2016
Last verified: January 2016

November 27, 2012
January 8, 2016
March 2013
December 2015   (final data collection date for primary outcome measure)
To assess changes in non-motor symptoms using Non-Motor Symptom Scale [ Time Frame: Baseline compared to Week 12 ] [ Designated as safety issue: No ]
To assess changes in non-motor symptoms using Non-Motor Symptom Scale [ Time Frame: Baseline compared to Week 12 ] [ Designated as safety issue: No ]
To assess changes in non-motor symptoms using Non -Motor Symptom Scale
Complete list of historical versions of study NCT01736176 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 non-motor symptoms using Non -Motor Symptom Scale
  • 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 changes in motor symptoms using United Parkinson's Disease Rating Scale
  • 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 improvements in cognition using neurocognition assessments: Spatial Working Memory
  • To assess improvements in cognition using neurocognition assessments:Controlled Oral Word Association Test Verbal Fluency [ Time Frame: Baseline compared to Week 12 ] [ Designated as safety issue: No ]
    To assess improvements in cognition using neurocognition assessments: Controlled Oral Word Association Test Verbal Fluency
  • To assess improvements in cognition using neurocognition assessments: Controlled Oral Word Association Test Verbal Fluency [ Time Frame: Baseline compared to Week 60 ] [ Designated as safety issue: No ]
    To assess improvements in cognition using neurocognition assessments: Controlled Oral Word Association Test Verbal Fluency
  • 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: Parkinson's Disease Questionnaire-39 Item
  • 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: Patient Global Impression of Change
  • 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: Treatment Satisfaction Question
  • 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 quality of life through: Health-Related Productivity Questionnaire
  • To assess changes in motor symptoms using Parkinson's Disease Diary [ Time Frame: Baseline compared to Week 60 ] [ Designated as safety issue: No ]
    To assess changes in motor symptoms using Parkinson's Disease Diary
Not Provided
Not Provided
 
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
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
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.
Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Parkinson's Disease
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).
Experimental: Levodopa-Carbidopa Intestinal Gel
Single Arm, open label: Levodopa-Carbidopa Intestinal Gel
Intervention: Drug: Levodopa-Carbidopa Intestinal Gel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
December 2015
December 2015   (final data collection date for primary outcome measure)

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).
Both
30 Years to 99 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01736176
M12-920
No
Not Provided
Not Provided
AbbVie (prior sponsor, Abbott)
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Janet Benesh, BS AbbVie
AbbVie
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP