Azetukalner for Bipolar Disorder

Enrolling by invitation at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Xenon Pharmaceuticals Inc.

Disqualifiers: Pregnancy, Self-harm risk, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: Unknown

Duration: Long-term

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of a treatment called azetukalner for individuals with bipolar disorder, focusing on long-term safety and patient tolerance. It targets participants who completed a previous trial with azetukalner and wish to continue observing its effects. Only those who successfully finished the earlier phase without major issues and agree to adhere to the study's guidelines can participate. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that azetukalner is likely to be safe for humans?

Research has shown that azetukalner has been tested for safety in several studies. In these trials, most participants tolerated azetukalner well. Some studies found that it improved depression symptoms without causing serious side effects.

One study compared azetukalner to a placebo (a harmless pill with no active ingredients). The results suggested that azetukalner did not cause more negative effects than the placebo, indicating a positive sign for the treatment's safety.

Since this trial is in a later phase, azetukalner has already undergone earlier tests to check its safety. This generally means that major safety issues have been ruled out, but individual experiences can vary. It is important to consult a healthcare provider about potential risks before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for bipolar disorder?

Most treatments for bipolar disorder, like mood stabilizers and antipsychotics, work by balancing neurotransmitters in the brain. But Azetukalner is unique because it targets a different pathway, potentially offering relief for those who don't respond well to existing medications. Researchers are excited about Azetukalner’s new mechanism of action, which could mean fewer side effects and faster-acting results compared to traditional options. This novel approach has the potential to significantly improve quality of life for people with bipolar disorder.

What evidence suggests that azetukalner might be an effective treatment for bipolar disorder?

Studies have shown that azetukalner can improve symptoms of depression in people with bipolar disorder. In earlier research, patients taking azetukalner experienced a noticeable decrease in depression levels compared to those taking a placebo, a pill with no active medicine. Researchers measured this using a tool that assesses depression severity. Additionally, azetukalner reduced feelings of anhedonia, the inability to feel pleasure. These findings suggest that azetukalner could effectively manage depression in bipolar disorder. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults who have Bipolar I or II and are currently experiencing depression. Participants must have completed a previous Phase 3 study of azetukalner successfully to join this one.

Inclusion Criteria

Participant successfully completed the treatment period in a Phase 3 antecedent study evaluating azetukalner in participants with bipolar depression

Participant is willing to comply with the contraception requirements

I understand the study's procedures and agree to follow them.

Exclusion Criteria

Participant met any of the withdrawal criteria, discontinued study drug early, or was terminated early from an antecedent study

Participant had any protocol deviations in an antecedent study that, in the opinion of the investigator, would preclude participation in this study

Participant has any medical condition, personal circumstance, or ongoing AE (from an antecedent study) that, in the opinion of the investigator, exposes the participant to unacceptable risk by participating in the study or prevents adherence to the protocol

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 to evaluate long-term safety, tolerability, and efficacy

Long-term

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-CEED-OLE study is testing the long-term safety and effectiveness of a drug called azetukalner in treating bipolar depression over an extended period, without comparing it to another treatment or placebo.

How Is the Trial Designed?

Group I: Azetukalner 20 mg Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Xenon Pharmaceuticals Inc.

Lead Sponsor

Trials

19

Recruited

3,400+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07172516

NCT07172516 | A Randomized Study of Azetukalner ... X-CEED is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of azetukalner in adult participants ...

2. xenon-pharma.com xenon-pharma.com/product-pipeline/azetukalner-bpd/

Azetukalner (BPD) The primary efficacy endpoint is the change from baseline in the MADRS score at week 6 in patients who received azetukalner compared to placebo. Upon completion ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2834419

Azetukalner, a Novel KV7 Potassium Channel Opener, in ... These results suggest that azetukalner has the potential to improve symptoms of depression in patients with MDD, with a safety profile ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12117446/

Azetukalner, a Novel KV7 Potassium Channel Opener, in ... In this study, 20 mg of azetukalner demonstrated a significant reduction in anhedonia at week 6 compared with placebo as measured by SHAPS, ...

5. trialx.com trialx.com/clinical-trials/listings/308660/a-randomized-study-of-azetukalner-versus-placebo-in-depressive-episodes-associated-with-bipolar-i-or-ii-disorder-bipolar-depression/

A Randomized Study of Azetukalner Versus Placebo in ... X-CEED is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of azetukalner in adult participants ...

6. trial.medpath.com trial.medpath.com/clinical-trial/2452b5cd0f305997/nct07172516-azetukalner-bipolar-depression-efficacy-safety

A Randomized Study of Azetukalner Versus Placebo in ... X-CEED is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of azetukalner in adult ...

7. wpstorage3f9b8b58f9.blob.core.windows.net wpstorage3f9b8b58f9.blob.core.windows.net/wpblob3f9b8b58f9/wp-content/uploads/2024/10/Psych24Kenney.pdf

Efficacy and Safety of Azetukalner, a Novel, Potent KV7 ... - NET History of schizophrenia or other psychotic disorder, MDD with psychotic features, bipolar I or II ... He has served on a numerous data safety ...