A Study to Assess the Efficacy, Safety and Tolerability of ABT-SLV187 Monotherapy in Subjects With Advanced Parkinson's Disease (PD) and Persistent Motor Complications, Despite Optimized Treatment With Available Anti-Parkinsonian Medications
Condition: Advanced Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Levodopa-carbidopa intestinal gel; CADD-Legacy® 1400 ambulatory infusion pump; PEG tube; J-tube
Intervention description: Dose levels will be individually optimized. Infusion should be kept within a range of 0.5-10 mL/hour (10-200 mg levodopa/hour) and is usually 2-6 mL/hour (40-120 mg levodopa/hour); percutaneous endoscopic gastrostomy tube; jejunal tube
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: 31.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: levodopa; Advanced Parkinson's Disease; carbidopa; levodopa-carbidopa intestinal gel; Safety and Efficacy

Summary:

      The primary objective of this study is to measure the efficacy of ABT-SLV187 in subjects with
      advanced Parkinson's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of idiopathic Parkinson's disease according to the United Kingdom
             Parkinson's Disease Society (UKPDS) Brain Bank Criteria.

          2. Subjects have 4 or 5 in modified Hohn and Yahr (H & Y) classification of disease
             severity at "Off" state determined by the UPDRS Part V at Screening Visit 1.

          3. The subject's advanced Parkinson's disease must be levodopa-responsive as judged by
             the Investigator.

          4. Subjects have had optimal treatment with available Parkinson's disease medication as
             defined by local standards of care and, based upon the judgment of the Investigator,
             and their symptoms are judged inadequately controlled on this optimized treatment.
             Optimized treatment is defined as the maximum therapeutic effect obtained with
             available anti-parkinsonian pharmacological therapy when no further improvement is
             expected regardless of any additional manipulations of levodopa and/or other anti
             parkinsonian medication; this will be based on the Investigator's best clinical
             judgment.

          5. Presence of a recognizable "Off" and "On" state (motor fluctuations) as confirmed by
             UPDRS Part III (in both "On" and "Off" states), and by the Parkinson's Disease Diary©
             which must be observed and confirmed at Screening Visit 1.

          6. Subjects must be experiencing a minimum of 3 hours per day of "Off" time, as estimated
             by the Investigator and supported by the UPDRS at Screening Visit 1 and the
             Parkinson's Disease Diaries at baseline. The "Off" time must occur during a continuous
             16-hour interval, including the portion of the day during which the subject is awake
             the majority of the time (e.g., 5 AM to 9 PM, 7 AM to 11 PM).

        Exclusion Criteria:

          1. Parkinson's disease diagnosis is unclear or a suspicion of other parkinsonian
             syndromes exists, such as secondary Parkinsonism (caused by drugs, toxins, infectious
             agents, vascular disease, trauma, brain neoplasm), Parkinson's-plus syndromes (e.g.,
             multiple system atrophy, progressive supranuclear palsy) or the other
             neurodegenerative diseases that might mimic the symptoms of Parkinson's disease .

          2. Subjects who have undergone neurosurgery for the treatment of Parkinson's disease .

          3. Current primary psychiatric diagnosis of acute psychotic disorder or other
             uncontrolled primary psychiatric diagnoses, (e.g., bipolar disorder or major
             depressive disorder per Diagnostic and Statistical Manual of Mental Disorders 4th
             edition, Text Revision (DSM-IV-TR) criteria.

          4. Alzheimer's disease; or other significant cognitive impairment or dementia (defined as
             Mini-Mental State Examination (MMSE) total score < 24).

          5. Subject has significant current suicidal ideation within the previous year as
             evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of
             the Columbia-Suicide Severity Rating Scale (C-SSRS) completed at Screening or any
             history of suicide attempts.

          6. A low B12 level or low-normal B12 level (less than 300 pg/mL) with elevated
             methylmalonic acid (MMA). Note: Abnormal Vitamin B12 of questionable clinical
             significance (i.e., indeterminate or low normal results) prior to or at Screening
             Visit 2 require appropriate interpretation in conjunction with MMA and homocysteine
             laboratory values prior to proceeding further into the study.