Post-marketing Study of Gabapentin Enacarbil to Evaluate the Effect in Restless Leg Syndrome (RLS) Patients With Moderate Renal Impairment
Sponsored by Astellas Pharma Inc
About this trial
Last updated 6 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended 10 years ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
- Patients who have been diagnosed with restless legs syndrome (RLS) according to the international RLS Study Group Diagnostic Criteria
- Patients whose score is 15 or greater on the International RLS (IRLS) Rating Scale on the first day of the pre-observation period.
- Patients whose creatinine clearance level at the first day of pre-observation period is ≥30 mL/min to <60mL/min estimated by Cockcroft-Gaul t equation
- Patients who provide written consent
Exclusion Criteria
- Patients with sleep disorder such as sleep apnea syndrome, which affects the RLS evaluation
- Patients with history of augmentation and treatment rebound of RLS symptoms when using dopamine agonis
- Patients with neuropathy and movement disorder (diabetic neuropathy, Parkinson's disease, multiple sclerosis, dyskinesia, rheumatoid arthritis etc)
- Patients with uncontrolled diabetes [HbA1c>7.5% (NGSP value), in the past six months], iron deficiency anemia, or drug administration of hypnotic sedatives.
- Patients who attempted suicide within six months prior to the consent obtained, or who have been diagnosed as a suicide risk by investigator or sub-investigator
- Patients with moderate or severe depression
- Patients with alcohol dependence or drug intoxication or who have a history of abuse or drug dependence in the past one year
- Patients whose job is shift work, professional driver, or engaging in hazardous activities such as operating machinery
- Patients with history of hypersensitivity to gabapentin
- Patients who have experience to participate in other post-marketing clinical studies or clinical trials within 12 weeks prior to the start of pre-observation
- Others: patients who are concluded to be ineligible by an investigator or sub-investigator as ineligible