Study of AD128 Versus Placebo in Obstructive Sleep Apnea

NCT ID: NCT04449133

Last Updated: 2021-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-03
• Study Completion Date: 2020-10-31

Brief Summary

Obstructive Sleep Apnea (OSA) is the most common and serious of the sleep disorders. Long-term, OSA is associated with increased morbidity and mortality, with a number of adverse cardiovascular, neurocognitive, metabolic, and daytime functioning consequences. No drugs are currently approved for OSA treatment.

This is a randomized, double blind, placebo controlled, cross-over, inpatient phase 2 clinical trial to examine the efficacy and the safety of a fixed dose level of AD128 in patients with OSA.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment Group 1

AD128 for 7 days, then, after a wash-out period of 7-10 days, placebo for 7 days

Group Type: EXPERIMENTAL

AD128

Intervention Type: DRUG

Oral administration of two capsules before sleep for 7 days.

Placebo

Intervention Type: DRUG

Oral administration of two capsules before sleep for 7 days.

Treatment Group 2

Placebo for 7 days, then, after a wash-out period of 7-10 days, AD128 for 7 days

Group Type: EXPERIMENTAL

AD128

Intervention Type: DRUG

Oral administration of two capsules before sleep for 7 days.

Placebo

Intervention Type: DRUG

Oral administration of two capsules before sleep for 7 days.

Interventions

AD128

Oral administration of two capsules before sleep for 7 days.

Intervention Type: DRUG

Placebo

Oral administration of two capsules before sleep for 7 days.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients who are able to understand the nature of the study and to give free informed consent
• AHI ≥ 15 on screening/baseline PSG
• Any of the following conditions should be met:

1. Documented prior PSG within 1 year demonstrating AHI of 15 or higher

2. Documented Continuous Positive Airway Pressure (CPAP) intolerance or poor compliance (compliance is defined as self-reported use of CPAP 4 hours per night for 70% of nights) or CPAP-naïve.

3. Patients who have been using CPAP at least 4 hours nightly for at least 70% of the nights are eligible only if CPAP is not used for 2 weeks prior to the screening/study baseline PSG.

• Epworth Sleepiness Scale (ESS) score ≥ 4 for patients not using CPAP
• Previous surgical treatment for OSA is allowed if ≥ 1 year prior to enrollment.
• BMI between 18.5 and 40.0 kg/m2, inclusive

Exclusion Criteria

• History of narcolepsy.
• Clinically significant craniofacial malformation.
• Clinically significant cardiac disease or hypertension requiring more than 3 medications for control.
• Clinically significant neurological disorder, including epilepsy/convulsions
• History of schizophrenia, schizoaffective disorder or bipolar disorder according to - Diagnostic and Statistical Manual of Mental Disorders-V (DSM V) or International Classification of Disease X edition criteria.
• History of attempted suicide or suicidal ideation within 1 year prior to screening, or current suicidal ideation.
• Positive history for abuse of drugs or substance use disorder as defined in DSM-V within 12 months prior to Screening Visit.
• A significant illness or infection requiring medical treatment in the past 30 days.
• Clinically significant cognitive dysfunction.
• Untreated narrow angle glaucoma.
• Women who are pregnant or nursing.
• History of using oral or nasal devices for the treatment of OSA may enroll as long as the devices are not used during participation in the study.
• History of using devices to affect participant sleeping position for the treatment of OSA, e.g. to discourage supine sleeping position, may enroll as long as the devices are not used during participation in the study.
• History of oxygen therapy.
• Use of medications from the list of disallowed concomitant medications.
• Treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors, or monoamine oxidase inhibitors (MAOI) or linezolid within 14 days of the start of treatment, or concomitant with treatment.
• Use of another investigational agent within 30 days or 5 half-lives, whichever is longer, prior to dosing.
• Central apnea index > 5/hour on baseline PSG
• Any condition that in the investigator's opinion would present an unreasonable risk to the participant, or which would interfere with their participation in the study or confound study interpretation.
• Patients considered by the investigator, for any reason, unsuitable candidates to receive AD128 treatment or unable or unlikely to understand or comply with the dosing schedule or study evaluations.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

YGHEA, CRO Division of Ecol Studio spa

INDUSTRY

Sponsor Role: collaborator

STM Pharma PRO srl

UNKNOWN

Sponsor Role: collaborator

Apnimed Inc.

UNKNOWN

Sponsor Role: collaborator

Istituto Auxologico Italiano

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elisa Perger, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Auxologico Italiano

Locations

Istituto Auxologico Italiano,Ospedale San Luca

Milan, , Italy

Countries

Italy

References

Perger E, Taranto Montemurro L, Rosa D, Vicini S, Marconi M, Zanotti L, Meriggi P, Azarbarzin A, Sands SA, Wellman A, Lombardi C, Parati G. Reboxetine Plus Oxybutynin for OSA Treatment: A 1-Week, Randomized, Placebo-Controlled, Double-Blind Crossover Trial. Chest. 2022 Jan;161(1):237-247. doi: 10.1016/j.chest.2021.08.080. Epub 2021 Sep 20.

Reference Type: DERIVED

PMID: 34543665 (View on PubMed)

Other Identifiers

2019-004917-15

Identifier Type: -

Identifier Source: org_study_id