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Label indication CABERGOLINE is an ergot derivative indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas in adults. Limitations of Use Avoid use of CABERGOLINE for the inhibition or suppression of postpartum physiologic lactation because of the risk of serious adverse reactions [see Warnings and Precautions (5.4) ] . FDA label
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 a small molecule being developed by Pfizer for the treatment of Restless Legs Syndrome. It has been studied in Phase 3 clinical trials in adults with this neurological condition. The trials were randomized, double-blind, and controlled, evaluating efficacy and safety compared with placebo.
Cabergoline targets the dopamine D2 receptor, also known as DRD2, where it acts as an agonist. By activating this receptor, it is designed to influence dopaminergic signaling relevant to Restless Legs Syndrome. This mechanism is distinct from drugs that block or antagonize dopamine receptors.
Pfizer, Inc. is the developer of Cabergoline for Restless Legs Syndrome. The company trades under the ticker symbol PFE. Pfizer sponsored the Phase 3 clinical trials evaluating the drug in this indication.
Cabergoline is in Phase 3 development for Restless Legs Syndrome. Two Phase 3 trials have been completed, and no active trials are currently listed. The drug is investigational for this indication and has not been approved by the FDA for treating Restless Legs Syndrome.
Cabergoline has been evaluated in two completed Phase 3 trials for Restless Legs Syndrome: NCT00627003, which enrolled 43 participants, and NCT00625547, which enrolled 361 participants across Austria, Germany, Sweden, and Switzerland. Both were randomized, double-blind, controlled studies in adults aged 18 years and older.