A Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects With Advanced Parkinson's Disease (DYSCOVER)
Condition: Parkinson's Disease (PD)
MeSH terms: Parkinson Disease; Dyskinesias
Intervention: Optimized antiparkinsonian treatment; Levodopa-Carbidopa Intestinal Gel (LCIG); CADD-Legacy ambulatory infusion pump; Percutaneous endoscopic gastrostomy tube; Jejunal extension tube
Intervention description: Dose levels of prescribed antiparkinsonian medications were individually optimized to their maximum therapeutic effect.; Dose levels were individually optimized.; (manufactured by Smiths Medical); (PEG tube); (J-tube)
Intervention MeSH terms: Levodopa; Carbidopa; Carbidopa, levodopa drug combination; Antiparkinson Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: Carbidopa; Levodopa; Efficacy; Levodopa-carbidopa intestinal gel; Advanced Parkinson's Disease

Summary:

      The primary objective of this study was to examine the effect of levodopa-carbidopa
      intestinal gel (LCIG) compared with optimized medical treatment (OMT) on dyskinesia in
      participants with advanced Parkinson's disease (PD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must have a diagnosis of idiopathic Parkinson's disease (PD) according to
             the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria

          -  Participants with advanced levodopa-responsive PD and persistent motor fluctuations
             who have not been controlled with optimized medical treatment (OMT: the maximum
             therapeutic effect obtained with pharmacological antiparkinsonian therapies when no
             further improvement is expected with regard to any additional manipulations of
             levodopa and/or other antiparkinsonian medication based on the Investigator's clinical
             judgment)

          -  Unified Dyskinesia Rating Scale (UDysRs) Total score ≥ 30 at Visit 3

        Exclusion Criteria:

          -  Participant(s) treated with levodopa-carbidopa intestinal gel (LCIG) previously

          -  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

          -  Participant(s) has undergone neurosurgery for the treatment of Parkinson's disease.

          -  Participant(s) has contraindications to levodopa (e.g. narrow angle glaucoma,
             malignant melanoma)

          -  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