Post-marketing surveillance of DIACOMITCapsule, Powder for Oral Suspension

Post-marketing surveillance of DIACOMIT (Capsule: 250 mg or 500 mg, Powder for Oral Suspension: 250 mg or 500 mg)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1080225085

Enrollment

300

Registered

2020-02-25

Start date

2012-11-29

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 : DIACOMIT (Stiripentol) INN of investigational material : stiripentol Therapeutic category code : 113 Antiepileptics Dosage and Administration for Investi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients who start receiving DIACOMIT Tablet during the registration period.

Exclusion criteria

Exclusion criteria: Patients with a previous history of hypersensitivity to the ingredients of DIACOMIT.

Design outcomes

Primary

Measure	Time frame
safety Information about the adverse events that have occurred, by adverse reaction/infection category. Information about the safety specifications concerns that have occurred.	—

Secondary

Measure	Time frame
efficacy General improvement Responder rate	—

Countries

Japan

Outcome results

None listed

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