A Study to Examine the Efficacy of a Therapeutic THX-110 for Obstructive Sleep Apnea

SciSparc

Status and phase: Unknown; Phase 2

Conditions: Obstructive Sleep Apnea

Treatments: Drug: THX-110

Study type: Interventional

Funder types: Industry

Identifiers

NCT03646552

0079-17-ASMC

Details and patient eligibility

About

This is a sponsored proof of concept study with the purpose to examine the safety, tolerability and feasibility of THX-110 (Dronabinol (synthetic Δ9-THC) and PEA) for the treatment of adults with Obstructive Sleep Apnea.

Full description

This is a 30-day sponsor-initiated, open-label trial of the therapeutic treatment THX-110 (a combination of Dronabinol and PEA) in 30 adults with Obstructive Sleep Apnea (OSA). Participants will receive THX-110 for the duration of the trial. The goal for this pilot study is to provide initial safety, feasibility and tolerability data on THX-110 in an OSA population.

Enrollment: 30 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• OSA diagnosis; OSA severity AHI: 15-30
• Population aged 20-65
• Gender: Males and Females
• BMI < 30
• OSA patients that cannot tolerate CPAP
• OSA patients who use CPAP will not use the device during the entire duration of the study

Exclusion criteria

• Minors
• Severity of OSA outside the determined boundaries
• Pregnancy
• BMI > 30
• Medical history of narcotic dependency

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

THX-110

Experimental group

Description:

All participants will be titrated up on THX-110 (Dronabinol) dose during the first week of the trial (2.5mg Dronabinol for 3 days, 5mg Dronabinol for 3 days to 7.5mg Dronabinol for 3 days and finally increasing to 10mg for the remainder of the trial). Dronabinol will only be increased if the subject is tolerating the previous dose of Dronabinol and the Dronabinol may be reduced based on patient side-effects. Participants will be receiving 800mg PEA concomitantly.

Treatment:

Drug: THX-110