A Study to Examine the Effect of Levodopa-Carbidopa Intestinal Gel (LCIG) Therapy Relative to That of Optimized Medical Treatment (OMT) on Non-motor Symptoms (NMS) Associated With Advanced Parkinson's Disease (PD)
Condition: Advanced Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Optimized Medical Treatment; Levodopa-Carbidopa Intestinal Gel; Nasojejunal (NJ) tube; Percutaneous endoscopic gastrostomy with a jejunal (PEG-J) tube
Intervention description: Oral, sublingual or transdermal anti-PD medications and medications to treat NMS per Investigator discretion and/or in accordance with approved product label of the prescribed medications.; optional prior to PEG-J placement
Intervention MeSH terms: Levodopa; Carbidopa; Carbidopa, levodopa drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 89.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: levodopa-carbidopa intestinal gel; levodopa; carbidopa; Advanced Parkinson's Disease; Non-Motor Symptom Scale NMSS; Parkinson's Disease Sleep Scale PDSS-2; efficacy

Summary:

      The primary objective of this study is to examine the effect of LCIG relative to that of OMT
      on NMS associated with PD.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participant(s) must have a diagnosis of idiopathic Parkinson's disease according to
             the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria.

          2. Participant(s) demonstrates persistent motor fluctuations in spite of individually
             optimized treatment.

          3. The participant's Parkinson's disease is levodopa-responsive.

          4. Participant(s) has had optimized treatment with available anti-PD medication and their
             motor symptoms are judged inadequately controlled on this optimized treatment.
             Optimized treatment is defined as the maximum therapeutic effect obtained with
             pharmacological antiparkinsonian therapies when no further improvement is expected
             regardless of any additional manipulations of levodopa and/or other antiparkinsonian
             medication. This will be based on the Investigator's clinical judgment.

          5. Male or female participant(s) must be at least 30 years of age.

          6. Minimum Parkinson's Disease Sleep Scale 2 (PDSS-2) total score of 18 at Baseline
             assessment.

        Exclusion Criteria:

          1. Participant'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) or other neurodegenerative disease that might mimic the symptoms of PD.

          2. Participant(s) has undergone neurosurgery for the treatment of Parkinson's disease.

          3. Known hypersensitivity to levodopa, carbidopa or radiopaque material.

          4. Participant(s) has contraindications to levodopa (e.g. narrow angle glaucoma,
             malignant melanoma).

          5. Participant(s) experiencing clinically significant sleep attacks or clinically
             significant impulsive behavior (e.g. pathological gambling, hypersexuality) at any
             point during the three months prior to the Screening evaluation as judged by the
             Principal Investigator.