X-NOVA: A Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 in Major Depressive Disorder

Sponsor

Xenon Pharmaceuticals Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05376150

Collaborator

(none)

150

Enrollment

Locations

Arms

12.4

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a multicenter, Phase 2, double-blind, randomized, parallel-arm, placebo-controlled clinical trial to evaluate the efficacy, safety, and tolerability of XEN1101 in subjects with Major Depressive Disorder.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: XEN1101 10 mg Drug: XEN1101 20 mg Drug: Placebo	Phase 2

Detailed Description

The study is divided into 3 stages: Screening - up to 4 weeks duration; Treatment - 6 weeks duration; Follow-up - 4 weeks duration. The total study duration per subject is estimated to be approximately 14 weeks.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Proof-of-Concept, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 in Major Depressive Disorder

Actual Study Start Date :

May 19, 2022

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: XEN1101 10 mg During the double blind treatment period (42 days), subjects will take 1 capsule of XEN1101 10 mg, orally with food, per day	Drug: XEN1101 10 mg XEN1101 oral capsule
Experimental: XEN1101 20 mg During the double blind treatment period (42 days), subjects will take 1 capsule of XEN1101 20 mg, orally with food, per day	Drug: XEN1101 20 mg XEN1101 oral capsule
Placebo Comparator: placebo During the double blind treatment period (42 days), subjects will take 1 capsule of placebo, orally with food, per day	Drug: Placebo Placebo capsule

Arm

Intervention/Treatment

Experimental: XEN1101 10 mg

During the double blind treatment period (42 days), subjects will take 1 capsule of XEN1101 10 mg, orally with food, per day

Drug: XEN1101 10 mg

XEN1101 oral capsule

Experimental: XEN1101 20 mg

During the double blind treatment period (42 days), subjects will take 1 capsule of XEN1101 20 mg, orally with food, per day

Drug: XEN1101 20 mg

XEN1101 oral capsule

Placebo Comparator: placebo

During the double blind treatment period (42 days), subjects will take 1 capsule of placebo, orally with food, per day

Drug: Placebo

Placebo capsule

Outcome Measures

Primary Outcome Measures

Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score. [From baseline to end of treatment (Week 6).]
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations. [From randomization to Week 10.]

Secondary Outcome Measures

Change in Snaith-Hamilton Pleasure Scale (SHAPS) score. [From baseline to end of treatment (Week 6).]
Change in Beck Anxiety Inventory (BAI) score. [From baseline to end of treatment (Week 6).]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Key Inclusion Criteria:

Be properly informed of the nature and risks of the study and given written informed consent.
Male or female, aged 18 through 65 years (inclusive) with a body mass index (BMI) ≤35 kg/m².
Subject must meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for current MDD and currently in a moderate to severe major depressive episode (MDE), confirmed using the Mini International Neuropsychiatric Interview (MINI).
Current MDE duration ≥2 months and <24 months at the time of screening.
Current illness severity that is at least moderate, defined as a score of ≥20 on the HAM-D17 at screening and on Day 1.
Score ≥20 on the SHAPS at screening and on Day1.
Must be willing to comply with the study protocol for the full term of the study.

Key Exclusion Criteria:

A primary psychiatric diagnosis other than MDD as defined by DSM-5 (comorbid anxiety disorders [including agoraphobia, generalized anxiety disorder, social anxiety disorder, post-traumatic stress disorder (PTSD), and panic disorder] are allowed).
Concomitant use of antidepressants and/or other disallowed pharmacotherapy (including benzodiazepines).
History of schizophrenia or other psychotic disorder, MDD with psychotic features, bipolar I or II disorder, or MDD with mixed features.
History of non-response to >1 antidepressant drug due to lack of efficacy in the current MDE.
Failing >3 antidepressant drug trials, for any reason, in the current MDE.
History of non-response to electroconvulsive therapy (ECT) in the past 10 years.
Active suicidal plan/intent in the past 6 months, or more than 1 lifetime suicide attempt.
Females who are pregnant, breastfeeding, or planning to become pregnant during the first administration of study drug until 3 months after the last dose of study drug.
Meets criteria for a substance use disorder within the past 12 months, with the exception of tobacco use, and/or has a positive urine toxicology screen for drugs of abuse.
Any medical condition or personal circumstance that, in the opinion of the investigator, exposes the subject to unacceptable risk by participating in the study or prevents adherence to the protocol.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sunwise Clinical Research, LLC	Lafayette	California	United States	94549
2	Artemis Institute for Clinical Research	Riverside	California	United States	92503
3	Artemis Institute for Clinical Research	San Diego	California	United States	92103
4	Psych Atlanta, PC	Marietta	Georgia	United States	30060
5	Manhattan Behavioral Medicine, PLLC	New York	New York	United States	10036
6	FutureSearch Trials of Dallas, LP	Dallas	Texas	United States	75231