Safety and Effect of Mirapex(Pramipexole) Tablet Among Korean RLS

Boehringer Ingelheim

Status: Completed

Conditions: Restless Legs Syndrome

Study type: Observational

Funder types: Industry

Identifiers

NCT01170091

248.653

Details and patient eligibility

About

Safety and Effect of Mirapex(Pramipexole) tablet among Korean Restless Legs Syndrome Patients: An Open-Label, Postmarketing Surveillance Study

Full description

Study Design:

Enrollment: 651 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Moderate to severe Primary Restless Legs Syndrome
2. Male or female patients aged at least 18 years

Exclusion criteria

1. Any contraindications according to Basic Product Information (Company Core Data Sheet) or local Labelling; hypersensitivity to pramipexole or to any of the excipients.
2. Ongoing treatment with Mirapex
3. Pregnant and breastfeeding women
4. Concomitant pharmacologic treatment with other dopaminergic drugs(including L-dopa)
5. Secondary RLS

Trial design

651 participants in 1 patient group

Pramipexole