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NCT01887613 Clinical Trial

Specified Drug Use-Results Survey of Regnite

Restless Legs Syndrome Clinical Trial

Official title:
Specified Drug Use-Results Survey of Regnite

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01887613
Other study ID # REG001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2012
Est. completion date February 28, 2019

Study information
Verified date April 2019
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 1597
Est. completion date February 28, 2019
Est. primary completion date February 28, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Regnite
oral

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety such as occurrence of adverse drug reactions and lab-tests Up to 52 weeks
Secondary Restless Leg Syndrome score Baseline and at 52 weeks
Secondary Clinical Global Impression Baseline and at 52 weeks
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