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OpenTrials
Completed

NCT Number: NCT01887613

Specified Drug Use-Results Survey of Regnite

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.

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Key information

Conditions

Restless Legs Syndrome Dyssomnias Mental Disorders Nervous System Diseases Parasomnias Sleep Disorders, Intrinsic Sleep Wake Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

Chūbu, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Regnite

Drug

oral

Other names: gabapentin enacarbil

Primary outcomes

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

    Time frame: Up to 52 weeks

Secondary outcomes

  1. Restless Leg Syndrome score

    Time frame: Baseline and at 52 weeks

  2. Clinical Global Impression

    Time frame: Baseline and at 52 weeks

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Jun 27, 2013
Registry last updated
Apr 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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