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 - Full Text View

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:	Clinical Study Protocol M12-920 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:

Genetics Home Reference related topics: Parkinson disease Perry syndrome

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Levodopa Carbidopa

U.S. FDA Resources

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 ]
To assess changes in non-motor symptoms using Non -Motor Symptom Scale

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 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

Estimated Enrollment:	36
Study Start Date:	March 2013
Estimated Study Completion Date:	October 2015
Estimated Primary Completion Date:	July 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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01736176

Contacts

Contact: Willy Cramer, MS	847-393-6169	wil.cramer@abbvie.com
Contact: Melissa Vos, MS	847-938-1960	melissa.vos@abbvie.com

Locations

United States, Alabama
Site Reference ID/Investigator# 85176	Recruiting
Birmingham, Alabama, United States, 35294-0021
Principal Investigator: Site Reference ID/Investigator# 85176
United States, Kentucky
Site Reference ID/Investigator# 66682	Recruiting
Lexington, Kentucky, United States, 40536
Principal Investigator: Site Reference ID/Investigator# 66682

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:	March 15, 2013
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
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
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 23, 2013