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

• Register: ClinicalTrials.gov
• Last refreshed on: 26 July 2021
• Main ID: NCT01736176
• Date of registration: 27/11/2012
• Prospective Registration: Yes
• Primary sponsor: AbbVie (prior sponsor, Abbott)
• Public title: 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
• Scientific 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
• Date of first enrolment: March 2013
• Target sample size: 39
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01736176
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Janet Benesh, BS
• Affiliation: AbbVie

Key inclusion & exclusion 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).



Age minimum: 30 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Advanced Parkinson's Disease

Intervention(s)

Drug: Levodopa-Carbidopa Intestinal Gel

Drug: Levodopa-carbidopa Immediate Release (LC-IR) Tablets

Procedure: Percutaneous Endoscopic Gastrostomy with Jejunal Extension (PEG-J)

Primary Outcome(s)

Change From Baseline to Week 12 in the Non-Motor Symptom Scale (NMSS) Total Score [Time Frame: Baseline and Week 12]

Secondary Outcome(s)

Change From Baseline in NMSS Miscellaneous Domain Score [Time Frame: Baseline and Week 12 and Week 60]

Change From Baseline in NMSS Sexual Function Domain Score [Time Frame: Baseline and Week 12 and Week 60]

Percentage of Participants With a Patient Global Impression of Change (PGIC) Response of Improved [Time Frame: Week 12 and Week 60]

Change From Baseline in NMSS Attention/Memory Domain Score [Time Frame: Baseline and Week 12 and Week 60]

Change From Baseline in Parkinson's Disease Questionnaire-39 Item (PDQ-39) Summary Index [Time Frame: Baseline and Week 12 and Week 60]

Change From Baseline in CANTAB Spatial Working Memory Strategy Score at Week 12 [Time Frame: Baseline and Week 12]

Number of Participants With Adverse Events [Time Frame: 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)]

Change From Baseline in PDQ-39 Communication Domain Score [Time Frame: Baseline and Week 12 and Week 60]

Number of Participants Who Used Healthcare Resources Through Week 60 [Time Frame: Week 60]

Change From Baseline for Unified Parkinson's Disease Rating Scale (UPDRS) Total Score [Time Frame: Baseline and Week 12 and Week 60]

Change From Baseline in Mean Daily Normalized "Off" Time Based on Parkinson's Disease Diary [Time Frame: Baseline and Week 12 and Week 60]

Change From Baseline in NMSS Mood/Cognition Domain Score [Time Frame: Baseline and Week 12 and Week 60]

Change From Baseline in PDQ-39 Activities of Daily Living Domain Score [Time Frame: Baseline and Week 12 and Week 60]

Change From Baseline in PDQ-39 Stigma Domain Score [Time Frame: Baseline and Week 12 and Week 60]

Change From Baseline in UPDRS Dyskinesia Items Score [Time Frame: Baseline and Week 12 and Week 60]

Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Spatial Working Memory Between Errors Score at Week 12 [Time Frame: Baseline and Week 12]

Change From Baseline in Mean Daily Normalized "On" Time Without Troublesome Dyskinesia Based on PD Diary [Time Frame: Baseline and Week 12 and Week 60]

Change From Baseline in Controlled Oral Word Association Test (COWAT) Verbal Fluency Scores at Week 60 [Time Frame: Baseline and Week 60]

Treatment Satisfaction Questionnaire Scores [Time Frame: Week 12 and Week 60]

Change From Baseline in NMSS Cardiovascular Domain Score [Time Frame: Baseline and Week 12 and Week 60]

Change From Baseline in NMSS Urinary Domain Score [Time Frame: Baseline and Week 12 and Week 60]

Change From Baseline in Health-related Productivity [Time Frame: Baseline, Week 12 and Week 60]

Change From Baseline in UPDRS Part IV: Complications of Therapy Score [Time Frame: Baseline and Week 12 and Week 60]

Change From Baseline in PDQ-39 Bodily Discomfort Domain Score [Time Frame: Baseline and Week 12 and Week 60]

Change From Baseline in UPDRS Part I: Mentation, Behavior, and Mood Score [Time Frame: Baseline and Week 12 and Week 60]

Change From Baseline to Week 60 in the Non-Motor Symptom Scale (NMSS) Total Score [Time Frame: Baseline and Week 60]

Number of Participants Who Used Healthcare Resources During the First 4 Weeks [Time Frame: Weeks 1-4]

Change From Baseline in NMSS Gastrointestinal Tract Domain Score [Time Frame: Baseline and Week 12 and Week 60]

Change From Baseline in NMSS Sleep/Fatigue Domain Score [Time Frame: Baseline and Week 12 and Week 60]

Change From Baseline in PDQ-39 Cognition Domain Score [Time Frame: Baseline and Week 12 and Week 60]

Change From Baseline in PDQ-39 Mobility Domain Score [Time Frame: Baseline and Week 12 and Week 60]

Change From Baseline in UPDRS Part III: Motor Examination Score [Time Frame: Baseline and Week 12 and Week 60]

Change From Baseline in NMSS Perceptual Problems/Hallucinations Domain Score [Time Frame: Baseline and Week 12 and Week 60]

Change From Baseline in PDQ-39 Emotional Well-Being Domain Score [Time Frame: Baseline and Week 12 and Week 60]

Change From Baseline in PDQ-39 Social Support Domain Score [Time Frame: Baseline and Week 12 and Week 60]

Change From Baseline in UPDRS Part II: Activities of Daily Living (ADL) Score [Time Frame: Baseline and Week 12 and Week 60]

Change From Baseline in UPDRS Part V: Modified Hoehn and Yahr Staging Score [Time Frame: Baseline and Week 12 and Week 60]

Secondary ID(s)

M12-920

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 08/02/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01736176