MedTrace Logo

Study of Safety, Tolerability, Pharmacokinetics, and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease

NCT01479127 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2016-04-21

Study results available
· View outcomes & findings →

Summary

To explore the safety, tolerability, pharmacokinetics and efficacy of ABT-SLV187 in advanced Parkinson's disease (PD) patients with severe motor complications. The complications of medical devices for the naso-jejunum (NJ) infusion system of ABT-SLV187 will also be investigated.

Conditions

  • Advanced Parkinson's Disease

Interventions

DRUG

ABT-SLV187

DRUG

Oral Levodopa/Carbidopa

Tablet; contains 100 mg levodopa and 10 mg carbidopa

DEVICE

Infusion Pump: CADD-Legacy® 1400 Pump

General infusion pump, manufactured by Smiths Medical (US)

DEVICE

NJ-Tube: Silicon ED Tube

Device used to deliver nutrition/drug to stomach/intestine or to aspirate stomach fluid, manufactured by Create Medic Co., Ltd. (Japan)

DEVICE

Adaptor: Hakko Adaptor

Accessory set for fluid infusion set, consisting of caps, connectors and adapters, etc, manufactured by Hakko Medical (Japan)

Sponsors & Collaborators

  • Abbott Japan Co.,Ltd

    collaborator INDUSTRY

  • AbbVie (prior sponsor, Abbott)

    lead INDUSTRY

Principal Investigators

  • Yukihiro Kumamoto, MS · AbbVie Japan Co., Ltd

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-07-31
Completion
2012-07-31

More Related Trials

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 NCT01479127 on ClinicalTrials.gov