Open Phase III Study of ME2080 in Patients with Dravet Syndrome

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221082

Enrollment

Registered

2010-04-28

Start date

2010-04-28

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

Dravet Syndrome

Interventions

investigational material(s) Generic name etc : ME2080 (stiripentol) INN of investigational material : Therapeutic category code : 113 Antiepileptics Dosage and Administration for Investigational mate

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Seizure type: Patients who have an epileptic seizure at least 4 times per month 2)Inpatient/outpatient: Either inpatient or outpatient 3)Body weight: 5 kg or more 4)Concomitant antiepilepsy drugs: Patients receiving treatment with the following combinations of antiepilepsy drugs: - Clobazam e + Sodium valproat [+ Bromide] 5)Consent of patient: Patients whose written consent for participation in the study is provided by themselves or their delegates. When subjects complete the 12-week evaluation period, and patients themselves or their delegates hope continued administration, they will shift to the long-term administration phase.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Responder rate Changes in the seizure rate	—

Outcome results

None listed

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