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

JRCT ID: jRCT2031210624

Registered date:23/02/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Generalized tonic clonic seizures in adult patients with epilepsy
• Date of first enrollment: 12/07/2022
• Target sample size: 12
• Study type: Interventional
• Intervention(s): 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 interval of at least 2 weeks, with a maintenance dose of 200 mg once daily. The dose may be adjusted according to the patient's condition.

Outcome(s)

Primary Outcome

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 Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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.

Exclude 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.

Related Information

• Primary Sponsor: Osawa Masahiro