RecruitingPhase 3

ONO-2017 Study Japanese Patients With Primary Generalized Tonic Clonic Seizures.

Japan15 participantsStarted 2022-07-12

Plain-language summary

To investigate the efficacy and safety of ONO-2017 in combination with antiepileptics in Japanese epileptic patients with generalized tonic-clonic seizures.

Who can participate

Age range12 Years

SexALL

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Inclusion criteria

✓. Gender and age: Japanese patients, regardless of gender, aged 12 years or older at the time of informed consent.
✓. Subject has a clinical diagnosis of Primary Generalized Tonic-Clonic (PGTC) seizures in the setting of idiopathic generalized epilepsy.
✓. Subject experiences at least 5 Primary Generalized Tonic-Clonic (PGTC) seizures in 12 weeks.
✓. Subject is currently receiving 1 to a maximum of 3 concomitant Antiepileptic Drugs(AEDs) with fixed dosing regimens

Exclusion criteria

✕. Subject has a history of status epilepticus that required hospitalization within 15 months prior to enrollment.
✕. Subject has seizure clusters where individual seizures cannot be counted orclassified.
✕. History of non-epileptic or psychogenic seizures.
✕. Subject has a concomitant diagnosis of Partial Onset Seizure(POS).
✕. Subject has a history of any serious drug-induced hypersensitivity reaction (including but not limited to Stevens Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms(DRESS), Drug-induced hypersensitivity syndrome(DIHS)) or any drug-related rash requiring hospitalization.

What they're measuring

Percentage Change in generalized tonic-clonic (PGTC) seizure frequency per 28-Day Interval

Timeframe: 12 Weeks of the Maintenance Phase

Trial details

NCT IDNCT06579573

SponsorOno Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-01-31

Contact for this trial

North America Clinical Trial Support Desk

+18665877745(Toll-Free) clinical_trial@ono-pharma.com

View on ClinicalTrials.gov More Epilepsy, Generalized trials