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

Obstructive Sleep Apnea Clinical Trial

Official title:

Feasibility Study - Whether the Administration of the Dronabinol and PEA May Act as a Therapy for Obstructive Sleep Apnea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03646552
• Other study ID #: 0079-17-ASMC
• Status: Recruiting
• Phase: Phase 2
• Start date: June 4, 2018
• Est. completion date: April 2019

Study information

• Verified date: August 2018
• Source: Therapix Biosciences Ltd.
• Contact: Amit S Green, PhD
• Phone: +972 3 764 3226
• Email: amitg[@]assuta.co.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• THX-110
Participants will receive THX-110 in the following regimen: Dronabinol will be slowly titrated in the first 10 days of the study and PEA will be given in a constant dose of 800mg per day for the entire duration of the study. Patients will be followed for a total of 30 days.

Locations

Country	Name	City	State
Israel	Assuta HaShalom	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Therapix Biosciences Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Primary Safety Measurement: Serious Adverse Events (SAEs)	We will measure the incidence of all Serious Adverse Events (SAEs)	30 days
Other	Secondary Safety Measurement: Adverse Events (AEs): Anticipated and Unanticipated (uAEs)	We will measure the incidence of all Adverse Events (AEs): anticipated and unanticipated (uAEs).	30 days
Primary	A Significant Change in AHI Index	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	30 days
Secondary	A Change in Oxygen Desaturation Index (ODI)	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.	30 days