Study of AD128 Versus Placebo in Obstructive Sleep Apnea

NCT04449133 | Completed Phase 2

• 1 other identifier: 2019-004917-15
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Obstructive Sleep Apnea; Apnea Hypopnea Index

Outcome Measures

Primary Outcomes (1)

• Change in Apnea-Hypopnea Index (AHI)

  The percentage change of mean AHI will be compared between treatment groups.

  From the screening/baseline to the last day of treatment (7 days after the start of each treatment period).

Secondary Outcomes (14)

• AHI decrease ≥50%

  From screening/baseline to the last day of treatment (7 days after the start of each treatment period).

• AHI<15/hour

  From screening/baseline to the last day of treatment (7 days after the start of each treatment period).

• Change in Epworth Sleepiness Scale (ESS)

  From screening/baseline to the last day of treatment (7 days after the start of each treatment period).

• Change in Karolinska Sleepiness Scale (KSS)

  From screening/baseline to the last day of treatment (7 days after the start of each treatment period).

• Patient Global Impression of OSA Severity (PGI-S)

  From screening/baseline to the last day of treatment (7 days after the start of each treatment period).

Study Arms (2)

Treatment Group 1

EXPERIMENTAL

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

Drug: AD128; Drug: Placebo

Treatment Group 2

EXPERIMENTAL

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

Drug: AD128; Drug: Placebo

Interventions

AD128 DRUG

Oral administration of two capsules before sleep for 7 days.

Treatment Group 1; Treatment Group 2

Placebo DRUG

Oral administration of two capsules before sleep for 7 days.

Treatment Group 1; Treatment Group 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead
• YGHEA, CRO Division of Ecol Studio spa: collaborator
• STM Pharma PRO srl: collaborator
• Apnimed Inc.: collaborator

Study Sites (1)

Istituto Auxologico Italiano,Ospedale San Luca

Milan, Italy

Location

Related Publications (1)

• 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.

  PMID: 34543665 DERIVED

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

Study Officials

• Elisa Perger, MD

  Istituto Auxologico Italiano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients who meet the eligibility criteria will be assigned alternatively to the the treatment with a AD128 or matching placebo. After 7 days of treatment and a washout period, the patients will crossover to the other arm for 7 days.

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: June 26, 2020
• Study Start: July 3, 2020
• Primary Completion: October 30, 2020
• Study Completion: October 31, 2020
• Last Updated: September 27, 2021

Record last verified: 2021-09

Locations

IT (1)