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Obstructive Sleep ApneaPhase 2NCT04449133

Study of AD128 Versus Placebo in Obstructive Sleep Apnea

A Phase 2 study testing AD128 in people with Obstructive Sleep Apnea, run by Istituto Auxologico Italiano at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Obstructive Sleep Apnea
What is being tested?
AD128
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteItaly
Study dates
3 Jul 2020to 31 Oct 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Istituto Auxologico Italiano,Ospedale San Luca

    Milan

Other trials in Italy

About this study

Official title: Crossover, Double-blind, Phase 2 Study of AD128 Versus Placebo in Obstructive Sleep Apnea

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.

Being tested
AD128, Placebo
Keywords
Obstructive Sleep Apnea, Apnea Hypopnea Index
Medical subject headings
Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AD128Drug

    Oral administration of two capsules before sleep for 7 days.

  • PlaceboDrug

    Oral administration of two capsules before sleep for 7 days.

Study groups in NCT04449133
Study groupRoleWhat they receive
Treatment Group 1ExperimentalAD128 for 7 days, then, after a wash-out period of 7-10 days, placebo for 7 days
Receives: Drug: AD128; Drug: Placebo
Treatment Group 2ExperimentalPlacebo for 7 days, then, after a wash-out period of 7-10 days, AD128 for 7 days
Receives: Drug: AD128; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Apnea-Hypopnea Index (AHI)

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

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

Secondary outcomes (14)

  1. AHI decrease ≥50%

    The proportion of patients with AHI decrease ≥50% will be calculated.

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

  2. AHI<15/hour

    The number of patients with AHI <15/hour measured during the inpatient night Polysomnography will be compared between treatment groups.

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

  3. Change in Epworth Sleepiness Scale (ESS)

    The ESS is a self-administered questionnaire which measures the daytime sleepiness. The ESS score can range from 0 to 24. The change will be measured in terms of difference from baseline and between treatment groups.

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

  4. Change in Karolinska Sleepiness Scale (KSS)

    The KSS is a self-reported 9-points scale which measure the subjective level of sleepiness at a particular time during the day. The change will be measured in terms of difference from baseline and between treatment groups.

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

  5. Patient Global Impression of OSA Severity (PGI-S)

    The PGI-S is a single question asking the patient to rate on a scale, ranging from 0 to 4, the severity of the OSA condition at that time.

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

  6. Change in Psychomotor Vigilance Test (PVT)

    PVT is a chronometric measure of a patient's reaction time to a visual stimulus. PVT reaction times/lapses and failures to react will be measured. The change will be measured in terms of difference from baseline and between treatment groups.

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

  7. Change in Oxygen Desaturation Index (ODI) 3%

    The number of times per hour of sleep that the blood's oxygen level drops by 3% from baseline will be measured by means of a CE marked oximeter capable of nightly recording and storage of data for the entire at-home period. The change in mean value from baseline will be compared between treatment groups.

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

  8. Change in total time with Oxygen Saturation (SaO2) <90%

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

  9. Change in mean SaO2

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

  10. Change in minimum SaO2

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

  11. Change in arousal index

    The number of arousals will be registered during the polysomnography and reported as a frequency per hour of sleep. The change in mean value from baseline will be compared between treatment groups.

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

  12. Change in periodic limb movement

    The number of periodic limb movements will be measured during the polysomnography. The change in mean value from baseline will be compared between treatment groups.

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

  13. Oxygen Desaturation Index 4%

    The number of times per hour of sleep that the blood's oxygen level drops by 4% or more from baseline will be measured by means of a CE marked oximeter capable of nightly recording and storage of data. The average numbers will be compared between treatment groups.

    Measured: For the entire at home treatment period: days 1-7 (before crossover) and days 15-20 (after crossover)

  14. Adverse Events (AE)

    All adverse events occurring to patients after recruitment in the study will be recorded. The total number of AEs, their severity and their seriousness will be compared between treatment groups.

    Measured: From screening/baseline to 4 weeks after last day of treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2020
  2. Study start3 Jul 2020
  3. Primary completion30 Oct 2020
  4. Study completion31 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04449133
Sponsor's protocol ID
2019-004917-15
Other IDs
2019
Status last verified
Sep 2021
First submitted
23 Jun 2020
Last updated
27 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 34543665

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AD128 in people with Obstructive Sleep Apnea, run by Istituto Auxologico Italiano at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Apnea-Hypopnea Index (AHI) (time frame: From the screening/baseline to the last day of treatment (7 days after the start of each treatment period).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04449133, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2021.

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