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

AbbVie

Status and phase: Completed; Phase 3

Conditions: Advanced Parkinson's Disease

Treatments: Drug: Levodopa-Carbidopa Intestinal Gel; Drug: Levodopa-carbidopa Immediate Release (LC-IR) Tablets; Procedure: Percutaneous Endoscopic Gastrostomy with Jejunal Extension (PEG-J)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01736176

M12-920

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

Levodopa-Carbidopa Intestinal Gel

Experimental group

Description:

Participants had the PEG-J tube placement procedure performed on Study Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually. The starting total daily dose of LCIG was based solely on the daily dose of the oral levodopa taken immediately prior to Study Day 1 and was adjusted to obtain the optimal clinical response for the individual participant. Participants received treatment for up to 60 weeks; participants who completed their Week 60 visit before LCIG was commercially available had the option to extend their LCIG therapy, if in the opinion of the investigator, the participant would benefit from continued LCIG treatment.

Treatment:

Drug: Levodopa-carbidopa Immediate Release (LC-IR) Tablets

Drug: Levodopa-Carbidopa Intestinal Gel

Procedure: Percutaneous Endoscopic Gastrostomy with Jejunal Extension (PEG-J)