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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

NCT01960842 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2018-05-30

Study results available
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Summary

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

Conditions

  • Advanced Parkinson's Disease

Interventions

DRUG

Levodopa-carbidopa intestinal gel

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)

DEVICE

CADD-Legacy® 1400 ambulatory infusion pump

DEVICE

PEG tube

percutaneous endoscopic gastrostomy tube

DEVICE

J-tube

jejunal tube

Sponsors & Collaborators

Principal Investigators

  • Masayoshi Yanagawa, PhD · AbbVie Japan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2015-03-31
Completion
2015-03-31

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01960842 on ClinicalTrials.gov