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
Condition: Advanced Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Levodopa-Carbidopa Intestinal Gel; Percutaneous Endoscopic Gastrostomy with Jejunal Extension (PEG-J); Levodopa-carbidopa Immediate Release (LC-IR) Tablets
Intervention description: Levodopa-carbidopa intestinal gel (LCIG) for upper-intestinal infusion is a suspension of levodopa (20 mg/mL) and carbidopa monohydrate (5 mg/mL) in an aqueous gel, administered continuously by a portable pump via a percutaneous endoscopic gastrojejunostomy (PEG-J) tube.
The rate of LCIG infusion was expected to be within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances over a period of 16 consecutive hours.; After LCIG initiation, participants could take prescribed oral levodopa-carbidopa immediate or continuous release (i.e., oral LC prescribed by the investigator) for nighttime use.
Intervention MeSH terms: Levodopa; Carbidopa; Carbidopa, levodopa drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: Safety and efficacy; Advanced Parkinson's disease; levodopa-carbidopa intestinal gel,; carbidopa; levodopa; Non-Motor Symptom Scale

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).