Long-term safety and efficacy of cabergoline for the treatment of idiopathic restless legs syndrome: results from an open-label 6-month clinical trial.

STUDY OBJECTIVES: To assess the safety and efficacy of cabergoline in the treatment of idiopathic restless legs syndrome (RLS) patients.

DESIGN: Open-label intervention study for 26 weeks; no control group.

SETTING: 302 patients (73% women, aged 61 +/- 11 years) from 37 German neurologic outpatient departments and private practices.

INTERVENTION: Cabergoline was upwardly titrated over 4 weeks to individually optimized dosages. Median treatment duration was 181 days. The median daily dose of cabergoline was 1.5 mg.

MEASUREMENTS: Drug safety was assessed by adverse events; efficacy was evaluated with the RLS-6 and the International RLS Rating Scales.

RESULTS: In 48% of the study participants, investigators reported adverse events suspected to be drug related. Most adverse events were mild and transient and related to the gastrointestinal system (nausea: 16.6%) or the central nervous system (dizziness: 7.0%, headache: 4.6%). Premature dropout from the study occurred in 54 patients (17.9%), in 17 patients (3.0%) due to a drug-related adverse event. The severity of RLS symptoms at night, at bedtime, and during the day, as well as the International RLS Rating Scale total score improved during therapy. Satisfaction with sleep was increased (all P values < .001). In 5% of all patients, RLS symptoms worsened, and in a further 6.3%, response to therapy was poor. In 9 patients (3.0%) between 1 and 3 criteria for augmentation were noted.

CONCLUSIONS: Long-term therapy with cabergoline is a safe and well-tolerated treatment option for the great majority of patients with idiopathic RLS. The treatment was efficacious both for nighttime and daytime symptoms in this indication and may carry a low risk of augmentation.