Extension study in pediatric subjects with KCNQ2 Developmental andEpileptic 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-IT
• Lead Sponsor: Xenon Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-08
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• 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 protocolspecified worsening criteria will be considered as having completed participation in the primary study.
2. The caregiver is willing and able to be compliant with diary completion, visit schedule, and study drug administration.
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:
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 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