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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00625547 | A Study to Determine the Efficacy and Safety of Cabergoline for the Treatment of Patients With RLS | PHASE3 | COMPLETED | 361 | — | — | Jan 1, 2003 | Dec 1, 2004 | Oct 29, 2008 | 50 | Austria, Germany +2 |
| NCT00627003 | A Study to Evaluate the Efficacy and Safety of Cabergoline Compared With Placebo for the Treatment of RLS | PHASE3 | COMPLETED | 43 | — | — | Nov 1, 2002 | May 1, 2003 | Apr 25, 2011 | - | — |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| cabergoline | DRUG | Cabergoline oral tablets: 0.5 mg daily on Days 1 to 3, 1.0 mg daily on Days 4 to 7, 1.5 mg daily on Days 8 to 10, and 2.0 mg daily on Days 11 to 14 and then administered as a stable dose for a further 4 weeks; at Week 6, dose could be increased to 3 mg daily if patient experienced insufficient efficacy without impairing adverse events |
| levodopa | DRUG | Levodopa oral capsules: 25 mg twice daily on Days 1 to 3, 50 mg twice daily on Days 4 to 7, 100 mg twice daily on Days 8 to 14 and then administered as a stable dose for a further 4 weeks; at Week 6, dose could be increased to 150 mg twice daily if patient experienced insufficient efficacy without impairing adverse events |
| Placebo | OTHER | Placebo oral tablets administered daily for 5 weeks |
Inclusion Criteria: * Diagnosis of idiopathic RLS and had all 4 clinical manifestations of RLS * Moderate to severe symptoms of RLS as indicated by an IRLSSG-RS total score greater than or equal to 10 and a severity at night score of greater than or equal to 4 on an 11-point RLS-6 rating scale * No...