A Study to Examine the Efficacy of a Therapeutic THX-110 for Obstructive Sleep Apnea
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|ClinicalTrials.gov Identifier: NCT03646552|
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : August 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea||Drug: THX-110||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility Study - Whether the Administration of the Dronabinol and PEA May Act as a Therapy for Obstructive Sleep Apnea|
|Actual Study Start Date :||June 4, 2018|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2019|
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.
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.
- A Significant Change in AHI Index [ Time Frame: 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
- A Change in Oxygen Desaturation Index (ODI) [ Time Frame: 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.
- Primary Safety Measurement: Serious Adverse Events (SAEs) [ Time Frame: 30 days ]We will measure the incidence of all Serious Adverse Events (SAEs)
- Secondary Safety Measurement: Adverse Events (AEs): Anticipated and Unanticipated (uAEs) [ Time Frame: 30 days ]We will measure the incidence of all Adverse Events (AEs): anticipated and unanticipated (uAEs).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646552
|Contact: Amit S Green, PhD||+972 3 764 email@example.com|
|Contact: Lilach Kamer, MD||+972 3 764 firstname.lastname@example.org|
|Tel Aviv, Israel, 6789140|
|Contact: Lilach Kamer, MD +972 3 764 3226 email@example.com|