Specified Drug Use-Results Survey of Regnite

Astellas Pharma Inc1,597 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,597

Conditions

Restless Legs Syndrome

Interventions

RegniteDRUG

oral

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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)

Locations (7)

Unnamed facility

Chūbu, Japan

Unnamed facility

Hokkaido, Japan

Unnamed facility

Kansai, Japan

Unnamed facility

Kantou, Japan

Unnamed facility

Kyushu, Japan

Outcomes

Primary Outcomes

Safety such as occurrence of adverse drug reactions and lab-tests

Time frame: Up to 52 weeks

Secondary Outcomes

Restless Leg Syndrome score

Time frame: Baseline and at 52 weeks

Clinical Global Impression

Time frame: Baseline and at 52 weeks

Data from ClinicalTrials.gov

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