Open Phase III Study of ME2080 in Patients with Dravet Syndrome

Phase 3

• Conditions: Dravet Syndrome

• Registration Number: JPRN-jRCT2080221082
• Lead Sponsor: Meiji Seika Pharma Co., Ltd. (formerly MEIJI SEIKA KAISHA Co., LTD.)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-04-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 25

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

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified