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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01515410 | Study in Advanced Parkinson's Disease Patients With Predictable Motor Fluctuations | PHASE2 | COMPLETED | 34 | — | — | Jan 1, 2012 | Oct 1, 2012 | Mar 10, 2014 | 7 | United States |
"OFF" indicates wearing off motor fluctuations before the next levodopa dose. Percent "OFF" time is calculated as the total "OFF" time divided by the total awake time for each day and multiplied by 100. Patient diary-every 30min while awake for 3days prior to initial Day1 as baseline \& during the last 3days before Day10 for both treatments for dyskinesia state. Baseline is the average of the 3 days recorded in the patient diary prior to Day 1 of Period 1. End of Period is the average of the 3 days recorded in the patient diary prior to Day 10 in each period. Clinician-Assess efficacy at pre-dose, every 30min for Day1 and hourly for Day10 for dyskinesia state \& motor fluctuations at clinic visits.
| Arm | Type | Description |
|---|---|---|
| DM-1992 | EXPERIMENTAL | DM-1992, a gastric-retentive extended-release tablet containing 72.5mg carbidopa (CD) and 230mg levodopa (LD) |
| Sinemet IR | ACTIVE_COMPARATOR | An Immediate-release (IR) tablet containing 25mg carbidopa (CD) and 100mg levodopa (LD) |
| Name | Type | Description |
|---|---|---|
| DM-1992 | DRUG | 72.5mg carbidopa/230mg levodopa |
| Sinemet IR | DRUG | Immediate-release tablet containing 25mg carbidopa and 100mg levodopa |
Inclusion Criteria: 1. Men and women at least 30 years and older at the time of informed consent with advanced idiopathic Parkinson's disease with predictable wearing-off motor fluctuations with Hoehn and Yahr Stage II-III when "on." 2. Patients should be able to differentiate between the "ON" and ...