Epilepsy (partial seizure), schizophrenia, bipolar disorder, trigeminal neuralgia
Conditions
Interventions
HLA-A*3101-negative patients are treated with carbamazepine, whereas HLA-A*3101-positive patients are treated with alternative drugs (such as valproic acid, gabapentin, levetiracetam, topiramate, lith
Sponsors
RIKEN
Institute of Medical Science, The University of Tokyo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Japanese males and females with epilepsy (partial seizure), excitement of schizophrenia, manic phase of bipolar disorder, trigeminal neuralgia, who will take carbamazepine 2) Patients who have not been taking carbamazepine within a month before entry 3) Patients or legally authorized representative who can understand the contents of this study and will voluntarily give written informed consent
Exclusion criteria
Exclusion criteria: 1) Patients with a history of skin rash induced by carbamazepine. 2) Pregnancy and lactation patients 3) Patients with severe renal failure (serum creatinine>=2.5 mg/dL, or patients on hemodialysis) 4) Patients with cirrhosis 5) Patients with hypoproteinemia (serum albumin<=2.5 g/dL) 6) Patient who are incapable to understand the contents of this study and will not give informed consent 7) Patients who participate in other clinical studies 8) Patients judged by investigators as ineligible for study enrollment
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Incidence of other adverse events. 1) Fever 2) Sore throat 3) Fatigue 4) Dizziness 5) Insomnia 6) Gastrointestinal symptoms (asitia, obstipation, diarrhea, xerostomia, nausea, vomiting) | — |
Primary
| Measure | Time frame |
|---|---|
| Incidence of drug-induced skin rash. 1) Stevens-Johnson syndrome (SJS) 2) Toxic epidermal necrolysis (TEN) 3) Drug-induced hypersensitivity syndrome (DIHS) 4) Maculopapular eruption (MPE) 5) Erythema multiforme (EM) 6) Fixed drug eruption (FDE) | — |
Countries
Japan
Outcome results
None listed