Specified Drug Use-Results Survey of Regnite

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Astellas Pharma Inc
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01887613
First received: June 25, 2013
Last updated: NA
Last verified: June 2013
History: No changes posted
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Restless Leg Syndrome score [ Time Frame: Baseline and at 52 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impression [ Time Frame: Baseline and at 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 1500
Study Start Date: October 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (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

Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01887613

Contacts
Contact: Clinical Development Administration clinicaltrials_info@jp.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

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01887613     History of Changes
Other Study ID Numbers: REG001
Study First Received: June 25, 2013
Last Updated: June 25, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
Gabapentin

Additional relevant MeSH terms:
Restless Legs Syndrome
Nervous System Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Parasomnias
Mental Disorders

ClinicalTrials.gov processed this record on September 16, 2014