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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03646552
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Therapix Biosciences Ltd.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
Drug Information available for: Dronabinol

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.





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).



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646552


Contacts
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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
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Israel
Assuta HaShalom Recruiting
Tel Aviv, Israel, 6789140
Contact: Lilach Kamer, MD    +972 3 764 3226    lilachk@assuta.co.il   
Sponsors and Collaborators
Therapix Biosciences Ltd.

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Responsible Party: Therapix Biosciences Ltd.
ClinicalTrials.gov Identifier: NCT03646552     History of Changes
Other Study ID Numbers: 0079-17-ASMC
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Dronabinol
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists