A Study to Assess the Safety and Efficacy of Levodopa Carbidopa Intestinal Gel for the Treatment of Non-motor Symptoms in Subjects With Advanced Parkinson's Disease



Status:Completed
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:30 - 99
Updated:4/21/2016
Start Date:March 2013
End Date:December 2015

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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

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.


Inclusion Criteria:

- Subject must have a diagnosis of idiopathic Parkinson's disease 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).
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