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XEN1101 20 mg for Depression (X-NOVA Trial)

Phase 2
Waitlist Available
Research Sponsored by Xenon Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to week 10.
Awards & highlights

X-NOVA Trial Summary

This trial will test if XEN1101 is an effective, safe and tolerable treatment for Major Depressive Disorder.

Eligible Conditions
  • Depression

X-NOVA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to week 10.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to week 10. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score.
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations.
Secondary outcome measures
Change in Beck Anxiety Inventory (BAI) score.
Change in Snaith-Hamilton Pleasure Scale (SHAPS) score.

X-NOVA Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: XEN1101 20 mgExperimental Treatment1 Intervention
During the double blind treatment period (42 days), subjects will take 1 capsule of XEN1101 20 mg, orally with food, per day
Group II: XEN1101 10 mgExperimental Treatment1 Intervention
During the double blind treatment period (42 days), subjects will take 1 capsule of XEN1101 10 mg, orally with food, per day
Group III: placeboPlacebo Group1 Intervention
During the double blind treatment period (42 days), subjects will take 1 capsule of placebo, orally with food, per day
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
XEN1101 10 mg
2022
Completed Phase 2
~170
XEN1101 20 mg
2022
Completed Phase 2
~170

Find a Location

Who is running the clinical trial?

Xenon Pharmaceuticals Inc.Lead Sponsor
17 Previous Clinical Trials
2,747 Total Patients Enrolled
Study DirectorStudy DirectorXenon Pharmaceuticals Inc.
1,206 Previous Clinical Trials
489,486 Total Patients Enrolled
9 Trials studying Depression
6,091 Patients Enrolled for Depression

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the 20 mg dosage of XEN1101 been granted regulatory approval by the FDA?

"XEN1101 20 mg achieved a rating of 2 on Power's safety scale due to having some experimental research indicating its security, but no evidence demonstrating efficacy."

Answered by AI

Are there any available slots in this clinical experiment?

"The information provided on clinicaltrials.gov states that this experiment is enlisting participants as of now. It was announced to the public on May 19th 2022 and most recently adjusted on July 11th, 2022."

Answered by AI

How many participants are partaking in this experiment?

"In order to properly conduct this clinical trial, 150 suitable subjects must be recruited. The sponsor Xenon Pharmaceuticals Inc. will host the study at Artemis Institute for Clinical Research in Riverside, California and Manhattan Behavioral Medicine, PLLC located in New york City."

Answered by AI

Is eligibility for this research endeavor open to octogenarians?

"This study has outlined requirements that individuals looking to participate must be aged between 18 and 65. In contrast, there are 405 trials available for minors and 1457 studies designed specifically for senior citizens."

Answered by AI

Are there any metropolitan areas in which this trial is currently taking place?

"As of now, 6 medical sites are running this trial. These include Riverside, New york and Dallas as well as 3 other areas. It is suggested that participants choose the closest centre in order to reduce travelling demands."

Answered by AI

What are the qualifications for enrollment in this trial?

"Eligibility for this clinical trial necessitates that participants are of ages 18-65 and have the specified medical condition. A total of 150 patients will be enrolled in the study."

Answered by AI

Who else is applying?

What state do they live in?
California
Louisiana
Texas
How old are they?
18 - 65
What site did they apply to?
Artemis Institute for Clinical Research
FutureSearch Trials of Dallas, LP
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 in Major Depressive Disorder
2022. "A Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 in Major Depressive Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05376150.
~58 spots leftby Apr 2025
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