Specified Drug Use-Results Survey of Regnite

Astellas

Status: Completed

Conditions: Restless Legs Syndrome

Treatments: Drug: Regnite

Study type: Observational

Funder types: Industry

Identifiers

NCT01887613

REG001

Details and patient eligibility

About

This study is to investigate the long-term safety and efficacy and the information on the proper use of Regnite® under conditions of daily clinical use.

Full description

Sleeping condition and severity of restless legs syndrome (RLS) were recorded at the start and during the treatment. The treatment period is scheduled to last 52 weeks in principle. For patients completing or discontinuing the use of Regnite® within 52 weeks, follow up on the withdrawal and rebound syndrome will be conducted up to 4 weeks of completion or discontinuation.

Enrollment: 1,597 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with moderate to severe idiopathic restless legs syndrome

Exclusion criteria

• Patients with a history of hypersensitivity to any ingredients in Regnite or gabapentin
• Patients with severely impaired renal function (creatinine clearance of less than 30 mL/min)

Trial design

1,597 participants in 1 patient group

Regnite group

Description:

Patients who receive Regnite

Treatment:

Drug: Regnite