Restless Legs Syndrome
Conditions
Keywords
Restless legs syndrome patients, ASP8825, XP13512
Brief summary
The objective of this study is to evaluate the efficacy and safety of ASP8825 (gabapentin enacarbil) for long-term treatment of restless legs syndrome patients.
Interventions
DRUGASP8825
Oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients who diagnosed with RLS according to the diagnostic criteria established by the International RLS Study Group * International Restless Legs Syndrome Scale (IRLS) score ≥15 presence of RLS symptoms on ≥15 days per month and ≥4 days per week preceding inclusion in this study
Exclusion criteria
* Patients using dopamine agonists or gabapentin within 1 week before or any anti-RLS treatment within 2 weeks before the start of the pretreatment observation period * Patients with an estimated creatinine clearance \<60 mL/min determined using the Cockcroft-Gault formula * Pregnant or lactating women * Individuals with serum ferritin \<20 ng/mL were also excluded from the trial * Individuals with movement disorders and/or abnormal neurological findings
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in IRLS score | Baseline to Week 52 | IRLS: International Restless Legs Syndrome Scale |
| Safety assessed by Vital signs | Up to Week 52 | Blood pressure and pulse rate |
| Safety assessed by Adverse Events | Up to Week 52 | — |
| Safety assessed by Laboratory tests | Up to Week 52 | Hematology, blood biochemistry, thyroid function test and urinalysis |
| Safety assessed by 12-lead-electrocardiogram | Up to Week 52 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in MOS sleep scale | Baseline to Week 52 | MOS: Medical outcomes study |
| Proportion of responders on ICGl of improvement | Up to Week 52 | ICGI: Investigator-rated Clinical Global Impression of improvement |
| Plasma concentration of gabapentin | Week 12, 28 and 52 | — |
| Proportion of responders on PCGI of improvement | Up to Week 52 | PCGI: Patient-rated Clinical Global Impression |
| Change from baseline in PSQI | Baseline to Week 52 | PSQI: Pittsburgh Sleep Quality Index |
| Change from baseline in SF-36v2 | Baseline to Week 52 | SF-36v2: Medical Outcomes Study 36-Item Short-Form Health Survey version 2 |
| Change from baseline in RLS-QOL | Baseline to Week 52 | RLS-QOL: Restless Legs Syndrome Quality of Life Questionnaire |
Countries
Japan
Outcome results
None listed