NCT06579573 ONO-2017 Study Japanese Patients With Primary Generalized Tonic Clonic Seizures.
| NCT ID | NCT06579573 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Ono Pharmaceutical Co., Ltd. |
| Condition | Epilepsy, Generalized |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2022-07-12 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 15 participants in total. It began in 2022-07-12 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Project Leader
STUDY DIRECTOR
Ono Pharmaceutical Co., Ltd.
Frequently Asked Questions
Who can join the NCT06579573 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, studying Epilepsy, Generalized. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06579573 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 15 participants.
Is NCT06579573 currently recruiting?
Yes, NCT06579573 is actively recruiting participants. Contact the research team at clinical_trial@ono-pharma.com for enrollment information.
Where is the NCT06579573 trial being conducted?
This trial is being conducted at Aichi, Japan, Fukuoka, Japan, Fukushima, Japan, Hiroshima, Japan and 11 additional locations.
Who is sponsoring the NCT06579573 clinical trial?
NCT06579573 is sponsored by Ono Pharmaceutical Co., Ltd.. The principal investigator is Project Leader at Ono Pharmaceutical Co., Ltd.. The trial plans to enroll 15 participants.
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