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AD816 for Sleep Apnea (VicTor Trial)

Phase 2
Waitlist Available
Research Sponsored by Apnimed
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 14 days of treatment dosing per crossover arm (collected at the end of treatment dosing per crossover arm)
Awards & highlights

VicTor Trial Summary

This trial tests a drug to treat Obstructive Sleep Apnea, using a controlled study with participants taking placebo and the drug.

Eligible Conditions
  • Obstructive Sleep Apnea

VicTor Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days of treatment dosing per crossover arm (collected at the end of treatment dosing per crossover arm)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days of treatment dosing per crossover arm (collected at the end of treatment dosing per crossover arm) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Apnea-hypopnea index (AHI) 4%, AD816 vs. Placebo

VicTor Trial Design

6Treatment groups
Experimental Treatment
Group I: Order: Period C, Period B, Period AExperimental Treatment3 Interventions
The sequence of periods for each participant are assigned in random order. Each of the three crossover periods is 14 days of uninterrupted nightly dosing, with an initial lower-dose week of investigational product (IP) followed by a higher dose week (or placebo each week).
Group II: Order: Period C, Period A, Period BExperimental Treatment3 Interventions
The sequence of periods for each participant are assigned in random order. Each of the three crossover periods is 14 days of uninterrupted nightly dosing, with an initial lower-dose week of investigational product (IP) followed by a higher dose week (or placebo each week).
Group III: Order: Period B, Period C, Period AExperimental Treatment3 Interventions
The sequence of periods for each participant are assigned in random order. Each of the three crossover periods is 14 days of uninterrupted nightly dosing, with an initial lower-dose week of investigational product (IP) followed by a higher dose week (or placebo each week).
Group IV: Order: Period B, Period A, Period CExperimental Treatment3 Interventions
The sequence of periods for each participant are assigned in random order. Each of the three crossover periods is 14 days of uninterrupted nightly dosing, with an initial lower-dose week of investigational product (IP) followed by a higher dose week (or placebo each week).
Group V: Order: Period A, Period C, Period BExperimental Treatment3 Interventions
The sequence of periods for each participant are assigned in random order. Each of the three crossover periods is 14 days of uninterrupted nightly dosing, with an initial lower-dose week of investigational product (IP) followed by a higher dose week (or placebo each week).
Group VI: Order: Period A, Period B, Period CExperimental Treatment3 Interventions
The sequence of periods for each participant are assigned in random order. Each of the three crossover periods is 14 days of uninterrupted nightly dosing, with an initial lower-dose week of investigational product (IP) followed by a higher dose week (or placebo each week).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Period C
2023
Completed Phase 2
~30
Period A
2023
Completed Phase 2
~30
Period B
2023
Completed Phase 2
~30

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Who is running the clinical trial?

ApnimedLead Sponsor
14 Previous Clinical Trials
2,050 Total Patients Enrolled
Ronald Farkas, MDStudy DirectorApnimed Inc.
~12 spots leftby Jun 2025
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