Specified Drug Use-Results Survey of Regnite

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01887613
Recruitment Status : Active, not recruiting
First Posted : June 27, 2013
Last Update Posted : December 17, 2018
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief 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.

Condition or disease Intervention/treatment
Restless Legs Syndrome Drug: Regnite

Detailed 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.

Study Type : Observational
Actual Enrollment : 1597 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Specified Drug Use-Results Survey of Regnite
Actual Study Start Date : October 1, 2012
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Restless Legs

Group/Cohort Intervention/treatment
Regnite group
Patients who receive Regnite
Drug: Regnite
Other Name: gabapentin enacarbil

Primary Outcome Measures :
  1. Safety such as occurrence of adverse drug reactions and lab-tests [ Time Frame: Up to 52 weeks ]

Secondary Outcome Measures :
  1. Restless Leg Syndrome score [ Time Frame: Baseline and at 52 weeks ]
  2. Clinical Global Impression [ Time Frame: Baseline and at 52 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with moderate to severe idiopathic restless legs syndrome

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01887613

Chubu, Japan
Hokkaido, Japan
Kansai, Japan
Kantou, Japan
Kyushu, Japan
Shikoku, Japan
Touhoku, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Study Chair: Use Central Contact Astellas Pharma Inc

Responsible Party: Astellas Pharma Inc Identifier: NCT01887613     History of Changes
Other Study ID Numbers: REG001
First Posted: June 27, 2013    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018

Keywords provided by Astellas Pharma Inc:

Additional relevant MeSH terms:
Restless Legs Syndrome
Nervous System Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Mental Disorders
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents