Azetukalner for Depression

(X-NOVA2 Trial)

Recruiting at 25 trial locations

Overseen By Xenon Medical Affairs

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Xenon Pharmaceuticals Inc.

Must not be taking: Antidepressants, Benzodiazepines

Disqualifiers: Bipolar, Schizophrenia, Substance use, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

1 SuperSite 1 of this trial's clinic is recognized for rapid followup

2 Power Preferred Clinics 2 of this trial's clinics are considered top 20 on Power

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

450 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

X-NOVA2 is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of azetukalner as a monotherapy in adult participants diagnosed with Major Depressive Disorder (MDD)

Will I have to stop taking my current medications?

Yes, you will need to stop taking antidepressants and certain other medications like benzodiazepines at least 2 weeks before starting the trial (4 weeks for fluoxetine).

Are You a Good Fit for This Trial?

Adults aged 18-74 with Major Depressive Disorder (MDD) as per DSM-5, currently in a depressive episode lasting 6 weeks to 24 months. Participants must have had their first MDE before age 50 and have a BMI of ≤40 kg/m2. Excluded are those with other mood disorders, recent substance abuse, certain psychiatric conditions like bipolar or schizophrenia, active suicidal intent, non-suicidal self-harm within the past year, pregnancy, or recent antidepressant use.

Inclusion Criteria

Have you felt at least 3 of the following things recently? Feeling sad; low energy or feeling tired; hopelessness or putting yourself down; not being interested in things that you usually enjoy such as hobbies or activities, or friends and family; difficulty concentrating or focusing on things; appetite changes like pushing yourself to eat or overeating; difficulty falling or staying asleep, or oversleeping?

Exclusion Criteria

Have you tried 3 or more antidepressants that haven't worked?

Have you been diagnosed with Bipolar Disorder?

Have you been diagnosed with Obsessive-Compulsive Disorder?

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive azetukalner 20 mg or placebo as a monotherapy for Major Depressive Disorder

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Azetukalner

Trial Overview The X-NOVA2 study is testing Azetukalner against a placebo in adults with MDD. This Phase 3 trial is double-blind and placebo-controlled to ensure neither researchers nor participants know who receives the actual medication versus the placebo for unbiased results.

How Is the Trial Designed?

Group I: Azetukalner Experimental Treatment 1 Intervention

Azetukalner 20 mg

Group II: Placebo Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

Xenon Pharmaceuticals Inc.

Lead Sponsor

Trials

19

Recruited

3,400+