Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01484990 | A Pharmacokinetic Study of Levodopa and Carbidopa Intestinal Gel in Subjects With Advanced Parkinson's Disease | PHASE1 | COMPLETED | 19 | — | — | Apr 1, 2010 | Sep 1, 2010 | Nov 21, 2017 | - | — |
Levodopa, Carbidopa and Metabolite:Cmax, Cmin, Area Under Curve, T max, half life, peak-trough fluctuation.
Evaluation of orthostatic vitals signs, ECGs, and adverse event monitoring (Screening, Day -1, Day 1, Day 2), clinical lab testing and physical exam (Screening and Day 2)
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Levodopa-Carbidopa | DRUG | Intestinal Gel |
Inclusion Criteria 1. Male or female subjects at least 30 years old; 2. Subjects with advanced Parkinson's disease who are already on LCIG (Duodopa®) for at least 30 days; 3. Body mass index range from 18.0 to 30.0 kg/m2 Exclusion Criteria 1. Subjects who are considered to be violent or subjects ...