In 2024, we are planning to initiate a Phase 3 azetukalner program in major depressive disorder, based on topline data from our azetukalner Phase 2 X-NOVA clinical trial.
Saturday, December 7 Noon - 6:00 PM
Sunday, December 8 10:00 AM - 4:00 PM
Monday, December 9 10:00 AM - 2:00 PM.
The AES Annual Meeting brings together healthcare providers, scientists, advocates, industry, and other professionals dedicated to better outcomes for people with epilepsy.
Take a look through our AES 2024 poster presentations.
Long-Term Safety and Efficacy of Azetukalner, a Novel, Potent Kv7 Potassium Channel Opener in Adults With Focal Epilepsy: Update From the Ongoing 7-Year Open-Label Extension of X-TOLE | Jacqueline French, Roger Porter, Emilio Perucca, Martin Brodie, Cynthia Harden, Jenny Qian, Constanza Luzon Rosenblut, Christopher Kenney, Gregory N. Beatch
COMING SOONIs the Mental Health Burden of Epilepsy Under-Recognized in Patients Reporting Focal Onset Seizures? A Patient-Reported Outcomes Study | Joanne M. Wagner, Bhagyashree Oak, Brittany Smith, Amod Athavale, Jeffrey R. Skaar, Alvin Ong, Cynthia Harden
COMING SOONA Targeted Literature Review of Comorbidity Burden in Focal Epilepsy | Alvin Ong, Zarmina Khankhel, Darrin Benjumea, Grace Goldsmith-Martin, Agata Los, Dan Thornton
COMING SOONPotassium channels play a major role in the control of neuronal excitability and represent a promising treatment target for epilepsy.7,8
K+ channels repolarize membranes to end the action potential9
Kv7 channels9
View our clinical trial brochure for azetukalner in focal onset seizures and primary generalized tonic-clonic seizures to learn more.
VIEW BROCHUREX‑TOLE2 and X‑TOLE3 are two identical Phase 3, multicenter, randomized, double-blind, placebo-controlled trials to evaluate the clinical efficacy, safety, and tolerability of azetukalner as adjunctive treatment in adults aged ≥18 years diagnosed with FOS who are taking 1 to 3 ASMs.
Approximately 360 eligible subjects will be randomized 1:1:1 (azetukalner
ASM, antiseizure medication; FOS, focal onset seizures.
Screening/baseline period: Up to 9.5 weeks duration to assess the frequency of seizures.
Double-blind period (DBP): 12 weeks duration. There is no titration period.
Follow-up period: 8 weeks duration after the last dose of study drug for subjects who do not complete the 12-week DBP or who complete the DBP but do not enter the OLE study.
On completion of the double-blind period in X‑TOLE2 or X‑TOLE3, eligible patients may enter an open-label extension study for up to three years.13
Primary efficacy endpoint
Median percent change in monthly focal seizure frequency from baseline to DBP of azetukalner compared to placebo.1,2
For additional information, including inclusion and exclusion criteria, visit the X‑TOLE2 and X‑TOLE3 clinical trial pages.
X-ACKT is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of azetukalner as adjunctive treatment in adults aged ≥12 years with a seizure frequency of ≥3 PGTCS during the last 8 weeks of the baseline period and taking 1 to 3 ASMs.
Approximately 160 eligible subjects will be randomly assigned 1:1 (azetukalner
ASM, antiseizure medication; PGTCS, primary generalized tonic-clonic seizures.
Screening/baseline period: Up to 9.5 weeks duration to assess the frequency of seizures.
Double-blind period (DBP): 12 weeks duration. There is no titration period.
Follow-up period: 8 weeks duration after the last dose of study drug for subjects who do not complete the 12-week DBP or who complete the DBP but do not enter the OLE study.
On completion of the double-blind period in X-ACKT, eligible patients may enter an open-label extension study for up to three years.13
Primary efficacy endpoint
Median percent change in monthly PGTCS frequency from baseline through the DBP of azetukalner versus placebo.3
For additional information, including inclusion and exclusion criteria, visit the
Find out more about our azetukalner Epilepsy Phase 3 program by contacting medicalaffairs@xenon-pharma.com.