Trials / Completed
CompletedNCT01960842
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
An Open-Label, Single-Arm, Baseline-Controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of ABT-SLV187 Monotherapy in Subjects With Advanced Parkinson's Disease and Persistent Motor-Complications Despite Optimized Treatment With Available Anti-Parkinsonian Medication
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 30 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to measure the efficacy of ABT-SLV187 in subjects with advanced Parkinson's disease.
Detailed description
The study was composed of a screening period followed by 2 sequential on-treatment periods, as follows: * Screening Period (up to 28 days): determination of eligibility and discontinuation of antiparkinsonian disease medications other than levodopa-carbidopa immediate release (LC-oral) prior to nasojejunal (N-J) tube placement. * N-J Test Period (2 to 14 days): first hospitalization period, Baseline assessments, placement of N-J tube, and optimization of levodopa-carbidopa intestinal gel (LCIG) treatment via N-J tube and infusion pump (participant was hospitalized for N-J tube placement but hospitalization was not required for entire duration of LCIG treatment optimization). * PEG-J Period (12 weeks): second hospitalization period; placement of PEG-J tube; further optimization of LCIG treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2013-10-01
- Primary completion
- 2015-03-01
- Completion
- 2015-03-01
- First posted
- 2013-10-11
- Last updated
- 2018-05-30
- Results posted
- 2016-04-20
Source: ClinicalTrials.gov record NCT01960842. Inclusion in this directory is not an endorsement.