Clinical trials
Advancing investigational therapies to build a brighter future for people living with neurological and psychiatric disorders
We are working with leading investigators to conduct global, Phase 3 pivotal studies for our azetukalner program in epilepsy, major depressive disorder, and bipolar depression. These trials aim to deliver a potential new treatment option in disorders where recent innovation has been limited and patients continue to have significant unmet needs.
Focal seizures
The most common type of seizure in adults, originating in one side of the brain. Our epilepsy program includes two Phase 3 clinical trials, X-TOLE2 and X-TOLE3.
Screening and Baseline
Randomization
1:1:1
azetukalner 25 mg QD*
azetukalner 15 mg QD*
placebo QD*
Open-Label Extension
(25 mg QD*)
Final 8-Week Follow-up
(if not entering OLE)
QD=once daily.
*Administered as once-daily capsule with food and no titration period.
- Primary objective: Assess effect of azetukalner vs placebo on reducing focal onset seizure frequency
- Secondary objectives include assessing the effect on azetukalner vs placebo on RR50, early treatment effect as measured at Week 1, and PGI-C
To learn more about enrollment in the study, visit:
Generalized seizures
One of the most severe seizure types, which starts in and affects both sides of the brain. Our epilepsy program includes a Phase 3 clinical trial, X-ACKT, in primary generalized tonic-clonic seizures.
Screening and Baseline
Randomization
1:1:1
azetukalner 25 mg QD*
placebo QD*
Open-Label Extension
(25 mg QD*)
Final 8-Week Follow-up
(if not entering OLE)
QD=once daily.
*Administered as once-daily capsule with food and no titration period. Subjects aged ≥12 years and <18 years will receive either azetukalner 15 mg, azetukalner 25 mg, or placebo; subjects aged ≥18 years will receive either azetukalner 25 mg or placebo. There is no placebo dose in the OLE.
- Primary objective: Assess effect of azetukalner vs placeo on reducing frequency of primary generalized tonic clonic seizures
- Secondary objectives include assessing the effect on azetukalner vs placebo on RR50, seizure freedom, and PGI-C
To learn more about enrollment in the study, visit:
Major depressive disorder
The Phase 3 X-NOVA program is evaluating our lead candidate in major depressive disorder.
Screening and Baseline
Randomization
1:1:1
azetukalner 20 mg QD*
placebo QD*
Open-Label Extension
(20 mg QD*)
8-Week Follow-up
(if not entering OLE)
QD=once daily.
*Administered as once-daily capsule with food and no titration period. There is no placebo dose in the OLE.
- Primary objective: Change from baseline in HAM-D17 score at Week 6
- Secondary objectives include change from baseline in HAM-D17 score at Week 1, change from baseline in SHAPS score at Week 6, and change from baseline in CGI-S score at Week 6
To learn more about enrollment in the study, visit:
Bipolar depression
The Phase 3 X-CEED study is evaluating our lead candidate in bipolar I or II depression.
Screening and Baseline
Randomization
1:1:1
azetukalner 20 mg QD*
placebo QD*
Open-Label Extension
(20 mg QD*)
8-Week Follow-up
(if not entering OLE)
QD=once daily.
*Administered as once-daily capsule with food and no titration period.
- Primary objective: Change from baseline in MADRS score at Week 6
- Secondary objectives include change from baseline in MADRS score at Week 1; change from baseline in SHAPS score at Week 6; and change from baseline in CGI-S score at Week 6
To learn more about enrollment in the study, visit:
Contact us
To inquire about becoming an investigator for X-TOLE2 or X-TOLE3, please contact X‑TOLE@xenon‑pharma.com.
To inquire about becoming an investigator for X-ACKT, please contact X‑ACKT@xenon‑pharma.com.
For other general questions, please contact medicalaffairs@xenon‑pharma.com.
What participants can expect in a clinical trial
In a clinical trial, a participant will undergo screening to ensure eligibility, followed by regular monitoring and care. They may receive the study drug or a placebo. Trials vary in length, and some offer an extension period where all participants receive the study drug once the placebo-controlled period of the study ends. Xenon provides patient support, educational resources, and reimbursement for travel expenses.
Choosing to participate in a clinical trial helps advance medical research, improves treatment options, and delivers brighter futures.
