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DReAMzz- Dronabinol and Acetazolamide Medication for Sleep Apnea (ZZ). Dose Confirmation Crossover Study for IHL-42X in Subjects With Obstructive Sleep Apnea.

ConditionObstructive Sleep Apnea (OSA)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIncannex Healthcare Ltd

About this trial

The goal of this randomized, double-blind, multi-dose crossover clinical trial is to determine the safety and efficacy of IHL-42X in subjects with obstructive sleep apnea.

The primary endpoint is: Change in AHI4 at the end of each treatment period compared to baseline (each treatment period is 28 days).

The study will consist of three separate four-way crossover dose-comparison studies each comparing three dose strengths of IHL-42X to placebo. The double-blind four-way crossover will be conducted according to a Williams design. Each of the crossover studies will test different doses of dronabinol in combination with a distinct, set dose of acetazolamide. In total, nine different combinations of dronabinol and acetazolamide formulated as IHL-42X will be tested in the study. The optimal dose strength will be selected based on safety and efficacy over a 4-week treatment period.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged ≥18 and ≤65 years of age at the time of consent.

AHI4 ≥5

≤25% central or mixed apneas out of total AHI

no Cheyne-Stokes respiration

Disqualifiers

Body mass index (BMI) >40 kg/m2 (men) and >42 kg/m2 (women).

Diagnosed obesity hypoventilation syndrome or hypercapnia.

PAP-compliant, defined by use of PAP for ≥4 hours for at least 63 nights during the consecutive 90-day period.

Current use of custom-made oral appliances (mandibular advancement device, tongue retaining device, or mouth guard) or hypoglossal nerve stimulation devices. Devices must not be used for the duration of the study.

Trial design

Design model

Crossover

Treatments tested in this trial

  • IHL-42X: 2.5 mg dronabinol + 125 mg acetazolamide

    Drug

    DReAMzz Phase 2 Investigational Product - IHL-42X Dose 1

  • IHL-42X: 5 mg dronabinol + 125 mg acetazolamide

    Drug

    DReAMzz Phase 2 Investigational Product - IHL-42X Dose 2

  • IHL-42X: 7.5 mg dronabinol + 125 mg acetazolamide

    Drug

    DReAMzz Phase 2 Investigational Product - IHL-42X Dose 3

  • IHL-42X: 2.5 mg dronabinol + 250 mg acetazolamide

    Drug

    DReAMzz Phase 2 Investigational Product - IHL-42X Dose 4

  • IHL-42X: 5 mg dronabinol + 250 mg acetazolamide

    Drug

    DReAMzz Phase 2 Investigational Product - IHL-42X Dose 5

  • IHL-42X: 7.5 mg dronabinol + 250 mg acetazolamide

    Drug

    DReAMzz Phase 2 Investigational Product - IHL-42X Dose 6

  • IHL-42X: 2.5 mg dronabinol + 375 mg acetazolamide

    Drug

    DReAMzz Phase 2 Investigational Product - IHL-42X Dose 7

  • IHL-42X: 5 mg dronabinol + 375 mg acetazolamide

    Drug

    DReAMzz Phase 2 Investigational Product - IHL-42X Dose 8

  • IHL-42X: 7.5 mg dronabinol + 375 mg acetazolamide

    Drug

    DReAMzz Phase 2 Investigational Product - IHL-42X Dose 9

  • Placebo: Negative control

    Drug

    DReAMzz Phase 2 Placebo

Treatment groups

120 Participants
are divided into 10 treatment groups

10

Treatment groups

See each treatment group below.

Group A: IHL-42X: 2.5 mg dronabinol + 125 mg acetazolamideExperimental treatment 1 intervention
Group B: IHL-42X: 5 mg dronabinol + 125 mg acetazolamideExperimental treatment 1 intervention
Group C: IHL-42X: 7.5 mg dronabinol + 125 mg acetazolamideExperimental treatment 1 intervention
Group D: IHL-42X: 2.5 mg dronabinol + 250 mg acetazolamideExperimental treatment 1 intervention
Group E: IHL-42X: 5 mg dronabinol + 250 mg acetazolamideExperimental treatment 1 intervention
Group F: IHL-42X: 7.5 mg dronabinol + 250 mg acetazolamideExperimental treatment 1 intervention
Group G: IHL-42X: 2.5 mg dronabinol + 375 mg acetazolamideExperimental treatment 1 intervention
Group H: IHL-42X: 5 mg dronabinol + 375 mg acetazolamideExperimental treatment 1 intervention
Group I: IHL-42X: 7.5 mg dronabinol + 375 mg acetazolamideExperimental treatment 1 intervention
Group J: Placebo: Negative controlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in AHI4 at the end of each treatment period compared to baseline

To assess the change in efficacy at the end of each dosing period compared with baseline.

Time frame
Each treatment period (28 days)

Secondary outcomes

1

Percent change in AHI4 at the end of each treatment period compared to baseline

Time frame
Each treatment period (28 days)
2

Change in Functional Outcomes of Sleep Questionnaire 10-items (FOSQ-10) at the end of each treatment period compared to baseline

Time frame
Each treatment period (28 days)
3

Change in Patient-reported outcome measurement information system (PROMIS)-Fatigue 7a at the end of each treatment period compared to baseline

Time frame
Each treatment period (28 days)
4

Change in Patient-reported outcome measurement information system - Sleep Related Impairment (PROMIS-SRI) 8a at the end of each treatment period compared to baseline

Time frame
Each treatment period (28 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Incannex Healthcare Ltd

Lead sponsor

Source ClinicalTrials.gov
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