Trials / Completed
CompletedNCT01479127
Study of Safety, Tolerability, Pharmacokinetics, and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease
An Open-Label, Single-Arm, Baseline-Controlled, Multicenter Study to Explore the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- AbbVie (prior sponsor, Abbott) · Industry
- Sex
- All
- Age
- 30 Years – 99 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2011-10-01
- Primary completion
- 2012-07-01
- Completion
- 2012-07-01
- First posted
- 2011-11-24
- Last updated
- 2016-04-21
- Results posted
- 2016-03-15
Source: ClinicalTrials.gov record NCT01479127. Inclusion in this directory is not an endorsement.