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

Phase 2

• Conditions: Obstructive Sleep Apnea
• Interventions: Drug: THX-110

• Registration Number: NCT03646552
• Lead Sponsor: SciSparc

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2018-06-04
• Status Verified: 2018-08
• Study First Submitted: 2018-08-05
• Study First Submitted QC: 2018-08-22
• Last Update Submitted: 2018-08-22
• Study First Posted: 2018-08-24
• Last Update Posted: 2018-08-24
• Primary Completion: 2019-04
• Study Completion: 2019-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
THX-110	THX-110	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.

Primary Outcome Measures

Name	Time	Method
A Significant Change in AHI Index	30 days	A significant change in AHI index, which assesses the quality of sleep before and after the treatment.; The AHI is the number of apneas or hypopneas recorded during the study per hour of sleep. It is generally expressed as the number of events per hour. Based on the AHI, the severity of OSA is classified as follows: None/Minimal: AHI \< 5 per hour Mild: AHI ≥ 5, but \< 15 per hour Moderate: AHI ≥ 15, but \< 30 per hour Severe: AHI ≥ 30 per hour

Secondary Outcome Measures

Name	Time	Method
A Change in Oxygen Desaturation Index (ODI)	30 days	A change in oxygen desaturation index (ODI) before and after the treatment; ODI is the hourly average number of desaturation episodes, which are defined as at least 4% decrease in saturation from the average saturation in the preceding 120 seconds, and lasting 10 seconds.

Trial Locations

Locations (1)

Assuta HaShalom; 🇮🇱 Tel Aviv, Israel