ONO-2017-01: Phase III study of ONO-2017 in Japanese epileptic patients with generalized tonic-clonic seizure.

ONO-2017-01: ONO-2017 phase III study A multicenter, open-label study in Japanese patients with primary generalized tonic clonic seizures.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031210624

Enrollment

Registered

2022-02-23

Start date

2022-07-12

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized tonic clonic seizures in adult patients with epilepsy

Interventions

The initial oral dose of ONO-2017 is 12.5 mg once daily, which is increased to 25 mg at an interval of at least 2 weeks, then to 50 mg at an interval of at least 2 weeks, and then to 50 mg at an inter

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Gender and age: Japanese patients, regardless of gender, aged 12 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
The percent change in PGTC seizure frequency Percent change from baseline in PGTC seizure frequency per 28 days [ Time Frame: from Pretreatment Phase over the Maintenance Phase (12 weeks) ]	—

Secondary

Measure	Time frame
1.Percent change in all generalized seizure frequency per 28-day interval during the Maintenance Phase relative to Pretreatment Phase. 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.	—

Contacts

Public ContactSupport Desk JP

Ono Pharmaceutical Co.,LTD

clinical_trial@ono-pharma.com+81-120-278-120

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026