refractory epilepsy patients
Conditions
Interventions
investigational material(s)
Generic name etc : AllinOne-K-2
INN of investigational material :
Therapeutic category code : 729 Other diagnostic agents (except extracorporeal diagnostic medicines)
Dosa
Sponsors
Tomoyuki Miyazaki (Coordinating Investigator)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)refractory epilepsy patients (2)patients who are planned to undergo lesionectomy (3)patients who are without cerebral surgery (4)patients who are 20 years or older (5)patients who can consent to this study by oneself
Exclusion criteria
Exclusion criteria: (1)patients who have experienced the electric stimulation therapy (2)patients who have severe kidney dysfunction within 7 days before 1st registration (3)patients who have severe liver dysfunction within 7 days before 1st registration (4)patients who should avoid from taking MRI or PET examination (5)breast-feeding mothers, expecting mothers, females who desire to be a mother (6)patients who desire to bear a child within this study period (7)patients who take Fycompa or Topiramate within 4 weeks before 1st registration (8)Patients who are suspected of severe alcohol sensitivity (9)patients who have tumor suspected to be epileptogenic before 1st registration (10)patients who underwent unapproved nuclear medicine examination within 24 weeks before 1st registration (11)patients who underwent other clinical trials within 12 weeks before 1st registration (12)patients who have uncontrollable diabetes (13)patients whom study doctors consider unappropriated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy exploratory To examine the concordance rate in surgical epilepsy patients between the epileptogenic resion estimated by AMPA-PET (PVC image) and resection resion. | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy exploratory (1)To examine the concordance rate in surgical epilepsy patients between the epileptogenic resion estimated by AMPA-PET (subtraction image) and resection resion. (2)To examine the concordance rate in surgical epilepsy patients showing no lesion with MRI between the epileptogenic resion estimated by AMPA-PET and resection resion. (3)To examine the concordance rate in surgical epilepsy patients between the epileptogenic resion estimated by AMPA-PET and resection resion and evaluate the data separately depending on ILAE classification at 24 weeks after surgery (4)To examine the concordance rate in surgical epilepsy patients showing ILAE classification 1 at 24 weeks after surgerybetween the epileptogenic resion estimated by radiologists using AMPA-PET images and resection resion. (5)To evaluate the safety of AMPA-PET in refractory epilepsy patients. | — |
Countries
Japan
Outcome results
None listed