ONO-2017-01:Phase III study of ONO-2017 in Japanese epileptic patients with generalized tonic-clonic seizure.
- Conditions
- Generalized tonic clonic seizures in adult patients with epilepsy
- Registration Number
- JPRN-jRCT2031210624
- Lead Sponsor
- Osawa Masahiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 12
1.Gender and age: Japanese patients, regardless of gender, aged 18 years or older at the time of informed consent.
2. Subject has a clinical diagnosis of PGTC seizures in the setting of idiopathic generalized epilepsy.
3.Subject experiences at least 5 PGTC seizures in 12 weeks.
4.Subject is currently receiving 1 to a maximum of 3 concomitant AEDs with fixed dosing regimens.
1. Subject has a history of status epilepticus that required hospitalization within 15 months prior to enrollment.
2. Subject has PGTC seizure clusters where individual seizures cannot be counted orclassified.
3. History of non-epileptic or psychogenic seizures.
4. Subject has a concomitant diagnosis of POS.
5. Subject has a history of any serious drug-induced hypersensitivity reaction (including but not limited to Stevens Johnson syndrome, toxic epidermal necrolysis, DRESS, Drug-induced hypersensitivity syndrome(DIHS)) or any drug-related rash requiring hospitalization.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The percent change in PGTC seizure frequency <br>Percent change from baseline in PGTC seizure frequency per 28 days [ Time Frame: from Pretreatment Phase over the Maintenance Phase (12 weeks) ]
- Secondary Outcome Measures
Name Time Method 1.Percent change in all generalized seizure frequency per 28-day interval during the Maintenance Phase relative to Pretreatment Phase.<br>2.The percentage of subjects who have a 50%, 75%, 90%, and 100% reduction in all generalized seizure frequency per 28-day interval during the Maintenance Phase relative to Pretreatment Phase.