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Specified Drug Use-Results Survey of Regnite

This study is currently recruiting participants.
Verified December 2017 by Astellas Pharma Inc
Sponsor:
ClinicalTrials.gov Identifier:
NCT01887613
First Posted: June 27, 2013
Last Update Posted: December 8, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Astellas Pharma Inc
  Purpose
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 Intervention
Restless Legs Syndrome Drug: Regnite

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Specified Drug Use-Results Survey of Regnite

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

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

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

Estimated Enrollment: 1500
Actual Study Start Date: October 1, 2012
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Regnite group
Patients who receive Regnite
Drug: Regnite
oral
Other Name: gabapentin enacarbil

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
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
Criteria

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)
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01887613


Contacts
Contact: Clinical Development Administration Astellas.registration@astellas.com

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

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01887613     History of Changes
Other Study ID Numbers: REG001
First Submitted: June 25, 2013
First Posted: June 27, 2013
Last Update Posted: December 8, 2017
Last Verified: December 2017

Keywords provided by Astellas Pharma Inc:
Gabapentin

Additional relevant MeSH terms:
Restless Legs Syndrome
Nervous System Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Parasomnias
Mental Disorders
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
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