Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Cabergoline · 2 trials · 1 indication
| 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...
Cabergoline is an investigational small molecule being studied for the treatment of Restless Legs Syndrome (RLS). It has completed Phase 3 clinical trials evaluating its efficacy and safety in patients with RLS. The drug is not yet approved and remains in clinical development.
Cabergoline is being developed by Pfizer, Inc., which trades under the ticker symbol PFE on the New York Stock Exchange. The company has sponsored Phase 3 clinical trials of Cabergoline for Restless Legs Syndrome.
Cabergoline is in Phase 3 clinical development for Restless Legs Syndrome. Two Phase 3 trials have been completed, with a total of 404 patients enrolled. The drug is investigational and has not been approved by regulatory authorities.
Cabergoline has been studied in two completed Phase 3 trials for Restless Legs Syndrome: NCT00625547, which enrolled 361 patients across Austria, Germany, Sweden, and Switzerland, and NCT00627003, which enrolled 43 patients. Both trials were randomized, double-blind, and controlled.
Cabergoline is not FDA approved for Restless Legs Syndrome. It is an investigational drug that has completed Phase 3 clinical trials, but approval status has not been established. The drug remains in clinical development.