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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-04

Study Completion Date

2019-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of the Lung Deposition Rate and Distribution Pattern of Tiotropium Via HandiHalerTM in Healthy Subjects and Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT02172456

Pulmonary Disease, Chronic Obstructive

COMPLETED PHASE3

Inhaled Treprostinil (Tyvaso Nebulizer) For COPD Patients With Hypoxemia

NCT07037836

COPD (Chronic Obstructive Pulmonary Disease) Hypoxemia

RECRUITING PHASE2

Heliox in Experimental Upper Airway Obstruction

NCT00788788

Airway Obstruction Dyspnea

COMPLETED PHASE1/PHASE2

Tiotropium Bromide Inhalation Solution in Subjects With Chronic Obstructive Pulmonary Disease

NCT04780984

Chronic Obstructive Pulmonary Disease (COPD)

COMPLETED PHASE2

Effect of Tiotropium on Airway Diameter in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT02172391

Pulmonary Disease, Chronic Obstructive

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Obstructive Sleep Apnea

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

THX-110

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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