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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00099268 | Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy | PHASE3 | COMPLETED | 747 | — | — | Sep 1, 2004 | Nov 1, 2008 | Apr 23, 2012 | 73 | United States, Austria +12 |
Dyskinesia was assessed by a blinded rater at each visit. Time to dyskinesia was defined as the visit at which the rater first answered "yes" to the following question: "In your opinion, does this patient have dyskinesia?" Time to dyskinesia was estimated by Kaplan-Meier product limit estimate that takes into consideration patients who did not experience dyskinesia by censoring them at the end of the study.
| Arm | Type | Description |
|---|---|---|
| Carbidopa/levodopa/entacapone | EXPERIMENTAL | Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks. |
| Immediate release carbidopa/levodopa | ACTIVE_COMPARATOR | Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks. |
| Name | Type | Description |
|---|---|---|
| Carbidopa/levodopa/entacapone | DRUG | Carbidopa/Levodopa/Entacapone 12.5/50/200 mg and 25/100/200 mg capsules. |
| Immediate release carbidopa/levodopa | DRUG | Immediate release carbidopa/levodopa 12.5/50 mg and 25/100 mg capsules. |
Inclusion Criteria: * Clinical diagnosis of idiopathic Parkinson's disease * Diagnosis of Parkinson's disease for no more than 5 years Exclusion Criteria: * History, signs, or symptoms of atypical or secondary parkinsonism * Presence at baseline of drug-related wearing-off symptoms, dyskinesia or...