Back to resultsA Study to Examine the Efficacy of a Therapeutic THX-110 for Obstructive Sleep Apnea
Primary Purpose
Obstructive Sleep Apnea
Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
THX-110
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
Eligibility Criteria
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
Sites / Locations
- Assuta HaShalomRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
THX-110
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03646552
Brief Title
A Study to Examine the Efficacy of a Therapeutic THX-110 for Obstructive Sleep Apnea
Official Title
Feasibility Study - Whether the Administration of the Dronabinol and PEA May Act as a Therapy for Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 4, 2018 (Actual)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
April 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SciSparc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
THX-110
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
THX-110
Intervention Description
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.
Primary Outcome Measure Information:
Title
A Significant Change in AHI Index
Description
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
Secondary Outcome Measure Information:
Title
A Change in Oxygen Desaturation Index (ODI)
Description
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
Other Pre-specified Outcome Measures:
Title
Primary Safety Measurement: Serious Adverse Events (SAEs)
Description
We will measure the incidence of all Serious Adverse Events (SAEs)
Time Frame
30 days
Title
Secondary Safety Measurement: Adverse Events (AEs): Anticipated and Unanticipated (uAEs)
Description
We will measure the incidence of all Adverse Events (AEs): anticipated and unanticipated (uAEs).
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amit S Green, PhD
Phone
+972 3 764 3226
Email
amitg@assuta.co.il
First Name & Middle Initial & Last Name or Official Title & Degree
Lilach Kamer, MD
Phone
+972 3 764 3226
Email
lilachk@assuta.co.il
Facility Information:
Facility Name
Assuta HaShalom
City
Tel Aviv
ZIP/Postal Code
6789140
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lilach Kamer, MD
Phone
+972 3 764 3226
Email
lilachk@assuta.co.il
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Study to Examine the Efficacy of a Therapeutic THX-110 for Obstructive Sleep Apnea
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