Clinical trial NCT01736176: A Study to Assess the Safety and Efficacy of Levodopa-carbidopa Intestinal Gel (LCIG) for the Treatment of Non-motor Symptoms in Patients With Advanced Parkinson's Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Advanced Parkinson's Disease
Keywords: Safety and efficacy
Advanced Parkinson's disease
levodopa-carbidopa intestinal gel,
carbidopa
levodopa
Non-Motor Symptom Scale
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2012-11-29
Enrollment: 39
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Subject must have a diagnosis of idiopathic Parkinson's disease (PD) 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).

Primary outcomes:
measure: Change From Baseline to Week 12 in the Non-Motor Symptom Scale (NMSS) Total Score
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Number of Participants Who Used Healthcare Resources During the First 4 Weeks
timeFrame: Weeks 1-4
measure: Number of Participants With Adverse Events
timeFrame: Weeks 1-4 and Overall (from Week 1 through 30 days after the end of the LCIG Treatment Period; median duration of LCIG device exposure was 428 days)
measure: Number of Participants Who Used Healthcare Resources Through Week 60
timeFrame: Week 60
measure: Change From Baseline to Week 60 in the Non-Motor Symptom Scale (NMSS) Total Score
timeFrame: Baseline and Week 60
measure: Change From Baseline in NMSS Cardiovascular Domain Score
timeFrame: Baseline and Week 12 and Week 60
measure: Change From Baseline in NMSS Sleep/Fatigue Domain Score
timeFrame: Baseline and Week 12 and Week 60
measure: Change From Baseline in NMSS Mood/Cognition Domain Score
timeFrame: Baseline and Week 12 and Week 60
measure: Change From Baseline in NMSS Perceptual Problems/Hallucinations Domain Score
timeFrame: Baseline and Week 12 and Week 60
measure: Change From Baseline in NMSS Attention/Memory Domain Score
timeFrame: Baseline and Week 12 and Week 60
measure: Change From Baseline in NMSS Gastrointestinal Tract Domain Score
timeFrame: Baseline and Week 12 and Week 60
measure: Change From Baseline in NMSS Urinary Domain Score
timeFrame: Baseline and Week 12 and Week 60
measure: Change From Baseline in NMSS Sexual Function Domain Score
timeFrame: Baseline and Week 12 and Week 60
measure: Change From Baseline in NMSS Miscellaneous Domain Score
timeFrame: Baseline and Week 12 and Week 60
measure: Change From Baseline in Mean Daily Normalized "Off" Time Based on Parkinson's Disease Diary
timeFrame: Baseline and Week 12 and Week 60
measure: Change From Baseline in Mean Daily Normalized "On" Time Without Troublesome Dyskinesia Based on PD Diary
timeFrame: Baseline and Week 12 and Week 60
measure: Change From Baseline for Unified Parkinson's Disease Rating Scale (UPDRS) Total Score
timeFrame: Baseline and Week 12 and Week 60
measure: Change From Baseline in UPDRS Part I: Mentation, Behavior, and Mood Score
timeFrame: Baseline and Week 12 and Week 60
measure: Change From Baseline in UPDRS Part II: Activities of Daily Living (ADL) Score
timeFrame: Baseline and Week 12 and Week 60
measure: Change From Baseline in UPDRS Part III: Motor Examination Score
timeFrame: Baseline and Week 12 and Week 60
measure: Change From Baseline in UPDRS Part IV: Complications of Therapy Score
timeFrame: Baseline and Week 12 and Week 60
measure: Change From Baseline in UPDRS Dyskinesia Items Score
timeFrame: Baseline and Week 12 and Week 60
measure: Change From Baseline in UPDRS Part V: Modified Hoehn and Yahr Staging Score
timeFrame: Baseline and Week 12 and Week 60
measure: Change From Baseline in Parkinson's Disease Questionnaire-39 Item (PDQ-39) Summary Index
timeFrame: Baseline and Week 12 and Week 60
measure: Change From Baseline in PDQ-39 Mobility Domain Score
timeFrame: Baseline and Week 12 and Week 60
measure: Change From Baseline in PDQ-39 Activities of Daily Living Domain Score
timeFrame: Baseline and Week 12 and Week 60
measure: Change From Baseline in PDQ-39 Emotional Well-Being Domain Score
timeFrame: Baseline and Week 12 and Week 60
measure: Change From Baseline in PDQ-39 Stigma Domain Score
timeFrame: Baseline and Week 12 and Week 60
measure: Change From Baseline in PDQ-39 Social Support Domain Score
timeFrame: Baseline and Week 12 and Week 60
measure: Change From Baseline in PDQ-39 Cognition Domain Score
timeFrame: Baseline and Week 12 and Week 60
measure: Change From Baseline in PDQ-39 Communication Domain Score
timeFrame: Baseline and Week 12 and Week 60
measure: Change From Baseline in PDQ-39 Bodily Discomfort Domain Score
timeFrame: Baseline and Week 12 and Week 60
measure: Percentage of Participants With a Patient Global Impression of Change (PGIC) Response of Improved
timeFrame: Week 12 and Week 60
measure: Treatment Satisfaction Questionnaire Scores
timeFrame: Week 12 and Week 60
measure: Change From Baseline in Health-related Productivity
timeFrame: Baseline, Week 12 and Week 60
measure: Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Spatial Working Memory Between Errors Score at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in CANTAB Spatial Working Memory Strategy Score at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Controlled Oral Word Association Test (COWAT) Verbal Fluency Scores at Week 60
timeFrame: Baseline and Week 60
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Janet Benesh, BS
role: STUDY_DIRECTOR
References:
citation: Standaert DG, Rodriguez RL, Slevin JT, Lobatz M, Eaton S, Chatamra K, Facheris MF, Hall C, Sail K, Jalundhwala YJ, Benesh J. Effect of Levodopa-carbidopa Intestinal Gel on Non-motor Symptoms in Patients with Advanced Parkinson's Disease. Mov Disord Clin Pract. 2017 Nov-Dec;4(6):829-837. doi: 10.1002/mdc3.12526. Epub 2017 Sep 20.