NCT03646552

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Neurothera Labs Inc. · Industry
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-06-04
• Primary completion: 2019-04-01
• Completion: 2019-04-01
• First posted: 2018-08-24
• Last updated: 2018-08-24

Locations

1 site across 1 country: Israel

Regulatory

• FDA-regulated drug study