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Leállítva3. fázis

An Open-Label Extension of the Study XEN496 (Ezogabine) in Children With KCNQ2-DEE

A legfontosabb adatok

Ki végzi
Xenon Pharmaceuticals Inc.
Hol
Philadelphia és Tacoma (Egyesült Államok)Mind a 2 helyszín megnézéseMég 2 másik országban, 2 helyszínen
Állapot
Leállítva
Fázis
3. fázis
Résztvevők
8 fő vett részt
Kezdés
2021. aug. 17.
Befejezés
2023. nov. 17.
A vizsgálat típusa
Beavatkozással járó, 2 csoport
A vizsgált kezelések
  • XEN496
A regiszteradat frissítve
2025. február 14.
Miért állt le
Sponsor decision; not a safety decision

Ki vehet részt

Életkor
1 hónap – 6 év
Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 8 feltétel megnézéseKevesebb

Ki vehet részt

  • 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
  • The caregiver is willing and able to be compliant with diary completion, visit schedule, and study drug administration
  • 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

Ki nem vehet részt

  • It is anticipated that the subject will require treatment with at least 1 of the disallowed medications during the study
  • 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
  • Any conditions that were specified as exclusion criteria in the primary study, XPF-009-301
  • 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
  • Any adverse event(s) or serious adverse event(s) during the primary 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 study

Helyszínek itt: Egyesült Államok

Még 2 másik országban, 2 helyszínen

  • Children's Hospital of PhiladelphiaPhiladelphia, Egyesült ÁllamokNo longer taking part
  • MultiCare Health System - Mary Bridge Pediatrics - TacomaTacoma, Egyesült ÁllamokNo longer taking part

A vizsgálatról

Mit akar kideríteni a vizsgálat

To assess the long-term safety and tolerability of XEN496 in pediatric subjects with KCNQ2 developmental and epileptic encephalopathy (KCNQ2-DEE) who had participated in the primary study (XPF-009-301).

A vizsgálat 2 csoportja

  • Group 1: XEN496 onlyA vizsgált kezelés

    24-day blinded transition/titration period. Subjects who received XEN496 in the preceding study will continue to receive XEN496 at the same dose, in a blinded manner, without any further titration. To maintain the blinded aspect of the study, placebo will be dispensed to all subjects during the transition/titration period to ensure the total number of capsules are consistent across all subjects. Subjects who discontinue will be required to taper off study drug over a period of up to 15 days

    Kezelés: XEN496

  • Group 2: Placebo to XEN496A vizsgált kezelés

    24-day blinded transition/titration period. Subjects who were allocated to placebo in the preceding study, will be titrated to a tolerated dose up to a maximum dose of 21 mg/kg/day, with a maximum daily dose of 672 mg/day. To maintain the blinded aspect of the study, placebo will be dispensed to all subjects during the transition/titration period to ensure the total number of capsules are consistent across all subjects Subjects who discontinue or complete the study treatment will be required to taper off study drug over a period of up to 15 days.

    Kezelés: XEN496

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
An Open-Label Extension of the Study XEN496 in Children With KCNQ2 Developmental and Epileptic Encephalopathy
A regiszteradat frissítve
2025. február 14.