Extension study in pediatric subjects with KCNQ2 Developmental and Epileptic Encephalopathy

Phase 1

• Conditions: KCNQ2 Developmental and Epileptic Encephalopathy; MedDRA version: 20.0Level: PTClassification code 10077380Term: Epileptic encephalopathySystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2020-003447-28-BE
• Lead Sponsor: Xenon Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-31
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Subject completed participation in the primary study, XPF-009-301. A subject who withdraws from the primary study due to meeting protocol-specified worsening criteria will be considered as having completed participation in the primary study.
2. The caregiver is willing and able to comply with diary completion, visit schedule, and study drug administration requirements.
3. Subject’s caregiver achieved a minimum of 85% compliance with daily diary completion during both baseline and the double-blind period of the primary study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Any AE or SAE during Study XPF-009-301, which in the opinion of the investigator and the sponsor’s medical monitor, would preclude the subject’s entry into the OLE.
2. A clinically significant condition or illness, or symptoms other than those resulting from KCNQ2-DEE, present at screening/baseline that, in the opinion of the investigator, would pose a risk to the subject if s/he were to enter the study.
3. Any conditions that were specified as exclusion criteria in the primary study (XPF-009-301).
4. It is anticipated that the subject will require treatment with at least 1 of the disallowed medications during the study.
5. Any change in cardiac rhythm or atrioventricular conduction in the primary study that, in the investigator’s opinion, is a significant risk to subject safety.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified