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

• ClinicalTrials.gov Identifier: NCT03646552
• Recruitment Status: Unknown
• First Posted: August 24, 2018
• Last Update Posted: August 24, 2018
• Sponsor: SciSparc
• Information provided by (Responsible Party): SciSparc

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.

Condition or disease	Intervention/treatment	Phase
Obstructive Sleep Apnea	Drug: THX-110	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm

Intervention/treatment

Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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.

Other Outcome Measures:

1. Primary Safety Measurement: Serious Adverse Events (SAEs) [ Time Frame: 30 days ]
   We will measure the incidence of all Serious Adverse Events (SAEs)
2. 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).

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Amit S Green, PhD; +972 3 764 3226; amitg@assuta.co.il

Contact: Lilach Kamer, MD; +972 3 764 3226; lilachk@assuta.co.il

Locations

Israel

Assuta HaShalom; Recruiting

Tel Aviv, Israel, 6789140

Contact: Lilach Kamer, MD +972 3 764 3226 lilachk@assuta.co.il

Sponsors and Collaborators

SciSparc

More Information

• Responsible Party: SciSparc
• ClinicalTrials.gov Identifier: NCT03646552
• Other Study ID Numbers: 0079-17-ASMC
• First Posted: August 24, 2018
• Last Update Posted: August 24, 2018
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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

Additional relevant MeSH terms:

Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases