Restless Legs Syndrome
Conditions
Keywords
Gabapentin
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.
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.
Interventions
DRUGRegnite
oral
Sponsors
Astellas Pharma Inc
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety such as occurrence of adverse drug reactions and lab-tests | Up to 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Restless Leg Syndrome score | Baseline and at 52 weeks |
| Clinical Global Impression | Baseline and at 52 weeks |
Countries
Japan
Outcome results
None listed