Restless Legs Syndrome
Conditions
Keywords
ASP8825, Restless legs Syndrome, XP13512
Brief summary
To demonstrate the superiority of ASP8825 over placebo and the dose response in patients with restless legs syndrome
Detailed description
Three doses of ASP8825 are compared to placebo in efficacy and safety point of view in patients with restless legs syndrome
Interventions
DRUGASP8825
oral
DRUGPlacebo
oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with RLS, based on the International RSL Study Group Diagnostic Criteria * History of RLS symptoms at least 15 nights in the prior month or, if on treatment, this frequency of symptoms before treatment was started * Documented RLS symptoms for at least 4 of the 7 consecutive evenings/ nights during the baseline study period
Exclusion criteria
* A sleep disorder (e.g., sleep apnea) that may significantly affect the assessment of RLS * A history of RLS symptom augmentation or end-of-dose rebound with previous dopamine agonist treatment * Neurologic disease or movement disorder (e.g., diabetic neuropathy, Parkinson's Disease, Multiple Sclerosis, dyskinesias and dystonias
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of the International Restless Legs Syndrome rating scale score | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| The Pittsburgh sleep quality index | 12 weeks |
| The SF-36 Health Survey | 12 weeks |
| Patient- related Clinical Global Impression of Improvement | 12 weeks |
| The Medical Outcomes Study sleep scale | 12 weeks |
| Investigator-related Clinical Global Impression of Improvement | 12 weeks |
| The Restless Legs Syndrome QOL Questionnaire | 12 weeks |
Countries
Japan
Outcome results
None listed