A Phase 2 interventional study of THX-110 in Obstructive Sleep Apnea, sponsored by SciSparc. Status unknown at 1 site in Israel. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-08-24.
Sponsored by SciSparc · Phase 2, Interventional, and Treatment
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.
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.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's planned enrollment of 30 is below the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →SciSparc is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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.
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
Time frame: 30 days
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.
Time frame: 30 days
Primary Safety Measurement: Serious Adverse Events (SAEs)
We will measure the incidence of all Serious Adverse Events (SAEs)
Time frame: 30 days
Secondary Safety Measurement: Adverse Events (AEs): Anticipated and Unanticipated (uAEs)
We will measure the incidence of all Adverse Events (AEs): anticipated and unanticipated (uAEs).
Time frame: 30 days
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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