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

NCT03646552 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: 0079-17-ASMC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• 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

  30 days

Secondary Outcomes (1)

• A Change in Oxygen Desaturation Index (ODI)

  30 days

Other Outcomes (2)

• Primary Safety Measurement: Serious Adverse Events (SAEs)

  30 days

• Secondary Safety Measurement: Adverse Events (AEs): Anticipated and Unanticipated (uAEs)

  30 days

Study Arms (1)

THX-110

EXPERIMENTAL

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

Interventions

THX-110 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.

THX-110

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Minors
• Severity of OSA outside the determined boundaries
• Pregnancy
• BMI \> 30
• Medical history of narcotic dependency

Sponsors & Collaborators

• SciSparc: lead

Study Sites (1)

Assuta HaShalom

Tel Aviv, 6789140, Israel

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Amit S Green, PhD

CONTACT

+972 3 764 3226; amitg@assuta.co.il

Lilach Kamer, MD

CONTACT

+972 3 764 3226; lilachk@assuta.co.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2018
• First Posted: August 24, 2018
• Study Start: June 4, 2018
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: August 24, 2018

Record last verified: 2018-08

Locations

IL (1)