Neuralgia neuropathic pain, hemodialysis
Conditions
Interventions
Hemodialysis patients
Mirogabalin tablets 2.5mg will be taken for 12 weeks.
Control patients
No intervention
D000284
Sponsors
Kitamura Mineaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 15 hemodialysis patients and 10 control patients will be included. Hemodialysis Patients 1. Patients aged 18 years or older at the time of consent (regardless of gender and whether inpatient or outpatient) 2. Patients who have been on hemodialysis for at least six months 3. Patients who meet one or more of the following criteria at the time of consent - Patients diagnosed by an orthopedic specialist or otherwise receiving regular treatment for one of the following neuropathic pain conditions (spinal stenosis, carpal tunnel syndrome, sciatica, lumbar sciatica, cervical lumbar spondylolisthesis, herniated disc, lumbar compression fracture, spinal caries, entrapment neuropathy, phantom limb pain, post-traumatic/post-surgical sequelae, post-thoracotomy pain syndrome) - Patients diagnosed with postherpetic neuralgia - Patients with a history of diabetes and a diagnosis of peripheral neuropathy 4. Patients with moderate or severe neuropathic pain (VAS > 40) mm or greater) 5. Patients for whom written consent has been obtained from themselves to participate in the study. Control Cases 1. Patients aged 18 years or older at the time of consent (regardless of gender or whether inpatient or outpatient) 2. Patients with an estimated glomerular filtration rate (eGFR) of 60 ml/min/1.73m2 or greater within the past three months 3. Patients currently receiving outpatient care and taking mirogabalin at a dose of 10 mg to 30 mg daily for at least three months 4. Patients for whom written consent has been obtained from themselves to participate in the study.
Exclusion criteria
Exclusion criteria: Hemodialysis Patients 1. Patients with a history of adverse events related to pregabalin or mirogabalin administration 2. Patients using pregabalin or mirogabalin within the past month 3. Pregnant or possibly pregnant women, or women who are breastfeeding 4. Patients with concomitant treatment with probenecid or cimetidine 5. Patients with visual impairment 6. Patients who are expected to need surgery during the enrollment period 7. Patients with poorly controlled diabetes (HbA1c > 8.0%), regardless of current treatment 8. Patients who are deemed to have a poor survival prognosis during the observation period 9. Patients with advanced cancer 10. Patients with severe obesity (Body Mass Index [BMI] 30 kg/m2 or greater) 11. Patients who participate in other clinical trials or interventional studies 12. Any condition deemed inappropriate for study participation by the principal investigator or co-investigator Control patients 1. Patients with severe obesity (Body Mass Index [BMI] 30 kg/m2 or greater) 2. Patients with any condition deemed inappropriate for study participation by the principal investigator or sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemodialysis patients In this study, the primary endpoint will be the change in VAS score for neuropathic pain from pre-trial to 12 weeks after the start of the study. Control patients No primary outcome is settled. Only steady-state mirogabalin blood concentrations are measured. | — |
Secondary
| Measure | Time frame |
|---|---|
| Hemodialysis patients The secondary endpoint is the change in SF-8 from pre- to post-trial start. Control patients No secondary outcome is settled. | — |
Contacts
Public ContactMineaki Kitamura
Nagasaki University Hospital
Outcome results
None listed