Clinical trial NCT06579573: ONO-2017 Study Japanese Patients With Primary Generalized Tonic Clonic Seizures.
Official title: ONO-2017 Phase III Study A Multicenter, Open-label Study in Japanese Patients With Primary Generalized Tonic Clonic Seizures.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Epilepsy, Generalized
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2024-08-30
Enrollment: 15
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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 Primary Generalized Tonic-Clonic (PGTC) seizures in the setting of idiopathic generalized epilepsy.
3. Subject experiences at least 5 Primary Generalized Tonic-Clonic (PGTC) seizures in 12 weeks.
4. Subject is currently receiving 1 to a maximum of 3 concomitant Antiepileptic Drugs(AEDs) with fixed dosing regimens

Exclusion Criteria:

1. Subject has a history of status epilepticus that required hospitalization within 15 months prior to enrollment.
2. Subject has seizure clusters where individual seizures cannot be counted orclassified.
3. History of non-epileptic or psychogenic seizures.
4. Subject has a concomitant diagnosis of Partial Onset Seizure(POS).
5. 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.

Primary outcomes:
measure: Percentage Change in generalized tonic-clonic (PGTC) seizure frequency per 28-Day Interval
timeFrame: 12 Weeks of the Maintenance Phase
Secondary outcomes:
measure: Percentage Change in all generalized seizure frequency per 28-Day
timeFrame: 12 Weeks of the Maintenance Phase
measure: Percentage of Subjects with Reduction in Generalized Seizure Frequency per 28-Day Interval
timeFrame: 12 Weeks of the Maintenance Phase
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Aichi Medical University Hospital
city: Fukuoka
country: Japan
facility: Hospital of the University of Occupational and Environmental Health, Japan
city: Fukushima
country: Japan
facility: Southern TOHOKU Research Institute for Neuroscience Southern TOHOKU Medical Clinic
city: Hiroshima
country: Japan
facility: Local Independent Administrative Corporation Hiroshima City Hospital Organization Hiroshima City Hiroshima Citizens Hospital
city: Hokkaido
country: Japan
facility: Hokkaido University Hospital
city: Hyōgo
country: Japan
facility: Itami City Hospital
city: Ibaraki
country: Japan
facility: Tsuchiura Kyodo General Hospita
city: Ibaraki
country: Japan
facility: University of Tsukuba Hospital
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital
city: Kanagawa
country: Japan
facility: SHOWA University Fujigaoka Hospital
city: Kanagawa
country: Japan
facility: Yokohama City University Hospital
city: Niigata
country: Japan
facility: National Hospital Organization Nishiniigata Chuo Hospital
city: Osaka
country: Japan
facility: Koide Clinic of Epilepsy and Neurological Disorders
city: Saitama
country: Japan
facility: TMG Asaka Medical Center
city: Shizuoka
country: Japan
facility: NHO Shizuoka Institute of Epilepsy and Neurological Disorder
city: Tochigi
country: Japan
facility: Jichi Medical University Hospital
city: Tokyo
country: Japan
facility: Jikei University Hospital
city: Tokyo
country: Japan
facility: Maynds Tower Mental Clinic
city: Tokyo
country: Japan
facility: National Center of Neurology and Psychiatry
city: Tokyo
country: Japan
facility: Nihonbashi Neuro Clinic
city: Tokyo
country: Japan
facility: Shinjuku Neuro Clinic
city: Tokyo
country: Japan
facility: Tokyo Women's Medical University, Adachi Medical Center
city: Yamaguchi
country: Japan
facility: Yamaguchi Grand Medical Center
city: Yamanashi
country: Japan
facility: University of Yamanashi Hospital
city: Yamanashi
country: Japan
facility: Yamanashi Prefectural Central Hospital
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Project Leader
role: STUDY_DIRECTOR
References: