Clinical Trials Logo
  1. Home
  2. Restless Legs Syndrome
  3. NCT01887613
  4. Details
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
See also
  Status Clinical Trial Phase
Recruiting NCT04786314 - The Effect of Hot and Cold Water Application on Pregnant Women With Restless Leg Syndrome N/A
Completed NCT01455012 - Effects of Neupro on Cardiovascular Observations in Patients With Restless Legs Syndrome Phase 4
Terminated NCT01192503 - Safety and Efficacy of Rasagiline in Restless Legs Syndrome Phase 2/Phase 3
Completed NCT00530530 - ASP8825 - Study in Patients With Restless Legs Syndrome Phase 2
Completed NCT00721279 - Sifrol (Pramipexole) Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary Restless Legs Syndrome N/A
Completed NCT00942253 - Exercise Training in Dialysis Patients With Restless Legs Syndrome (RLS) Phase 2
Completed NCT00375284 - A 6 Week Trial to Study the Efficacy and Safety of a Starting Dose 0.25 mg Pramipexole (Mirapex) in Patients With RLS Phase 4
Completed NCT00479531 - Sequential Compression Devices for Treatment of Restless Legs Syndrome Phase 3
Recruiting NCT05581576 - Pitolisant in Refractory Restless Legs Syndrome Phase 4
Active, not recruiting NCT03218969 - Treatment of Restless Leg Syndrome (RLS) Augmentation With Ecopipam, a D1 Specific Antagonist Phase 1/Phase 2
Recruiting NCT04144790 - Impact of Iron Supplementation Treatment on Brain Iron Concentrations
Completed NCT05787080 - Massage, Oxidative and Antioxidant Enzymes in Hemodialysis Patients With Restless Legs Syndrome(RLS) N/A
Not yet recruiting NCT05529095 - Sublingual Apomorphine in Refractory Restless Legs Syndrome Phase 4
Recruiting NCT05044520 - Clinical Features Associated With Restless Legs Syndrome.
Withdrawn NCT03849001 - Impact of Acute Leg Cycling at Various Intensities on RLS Severity in Persons With MS N/A
Completed NCT03076541 - Cardiovascular Variability, Heart Rate Response, and Electromyogram Power Associated With Periodic Leg Movements. N/A
Recruiting NCT04145674 - A Proof of Concept, Phase 2, Double-blind, Randomized Trial With d-Methadone Product Versus Placebo Phase 2
Completed NCT02532608 - Infra-slow Oscillations During Sleep N/A
Completed NCT01528462 - Sleep Disorders Managed and Assessed Rapidly in Transient Ischemic Attack (TIA) and In Early Stroke
Completed NCT00748098 - Polysomnography Study of GSK1838262 Extended Release Tablets Versus Placebo in RLS and Associated Sleep Disturbance Phase 3