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Obstructive Sleep ApneaPhase 1/2SEEDNCT05101122

Study for Efficacy and Dose Escalation of AD313 + Atomoxetine (SEED)

A Phase 1/2 study testing Dosing 1: Atomoxetine and AD313 in people with Obstructive Sleep Apnea, run by Apnimed at 2 sites in United States.

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

The SEED study is designed to assess the safety and efficacy for Obstructive Sleep Apnea (OSA) of 3 escalating dose combinations of atomoxetine with AD313 compared to baseline and to atomoxetine alone. Read more about this study

Who is it for?
Ages 25 to 65 years
Conditions the study is for
Obstructive Sleep Apnea
What is being tested?
Dosing 1: Atomoxetine and AD313
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
2 sitesUnited States
Study dates
19 Oct 2021to 18 Apr 2022
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 25 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age and Sex
  • 25 to 65 years of age, inclusive, at the Screening Visit. Disease Measures
  • AHI 10 to 50 (hypopneas defined by 4% oxygen desaturation)
  • ≤25% of apneas are central or mixed apneas at V2 baseline PSG Weight
  • BMI between 18.5 and 40.0 kg/m2, inclusive, at the pre-PSG visit.
  • Male participants:
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  • If male and sexually active with female partner(s) of childbearing potential, participant must agree, from Study Day 1 through 1 week after the last dose of study drug, to practice the protocol specified contraception (see Appendix 4: Contraceptive Guidance and Collection of Pregnancy Information).
  • Female participants:
  • If a woman of childbearing potential (WOCBP), the participant must agree, from Study Day 1 through 1 week after the last dose of study drug, to practice the protocol specified contraception (See Appendix 4: Contraceptive Guidance and Collection of Pregnancy Information). All WOCBP must have negative result of a serum pregnancy test performed at screening.
  • If female and of non-childbearing potential, the participant must be either postmenopausal (defined as age ≥ 55 years with no menses for 12 or more months without an alternative medical cause) or permanently surgically sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
  • Informed Consent
  • Participant voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB)-approved informed consent prior to performing any of the Screening Visit procedures.
  • Participant must be able to understand the nature of the study and must have the opportunity to have any questions answered.

Who cannot join

  • Medical Conditions
  • History of clinically significant sleep disorder other than OSA.
  • Clinically significant craniofacial malformation.
  • Clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or hypertension requiring more than 2 medications for control (combination medications are considered as 1 medication for this purpose).
  • Clinically significant neurological disorder, including epilepsy/convulsions.
  • History of schizophrenia, schizoaffective disorder or bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders-5 (DSM 5) or International Classification of Disease tenth edition criteria.
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  • History of attempted suicide within 1 year prior to screening, or current suicidal ideation.
  • Medically unexplained positive screen for drugs of abuse or history of substance use disorder as defined in DSM-V within 24 months prior to Screening Visit.
  • A significant illness or infection requiring medical treatment in the past 30 days.
  • Clinically significant cognitive dysfunction as determined by investigator.
  • Women who are pregnant or nursing. Prior/Concomitant Therapy
  • History of using devices for OSA treatment, including CPAP, oral or nasal devices, or positional devices, may enroll as long as the devices have not been used for at least 2 weeks prior to first study visit and are not used during participation in the study.
  • History of chronic oxygen therapy.
  • Use of medications from the list of disallowed concomitant medications.
  • Treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors, strong cytochrome P450 2D6 (CYP2D6) inhibitors, or monoamine oxidase inhibitors (MAOI) within 14 days of the start of treatment, or concomitant with treatment.
  • Prior/Concurrent Clinical Study Experience
  • Use of another investigational agent within 30 days or 5 half-lives, whichever is longer, prior to dosing.
  • Diagnostic Assessments
  • Hepatic transaminases >2X the upper limit of normal (ULN), total bilirubin >1.5X ULN (unless confirmed Gilbert syndrome), estimated glomerular filtration rate < 60 ml/min.
  • PLM arousal index >15 Other Exclusions
  • <5 hours typical sleep duration.
  • ESS > 18
  • Night- or shift-work sleep schedule which causes the major sleep period to be during the day.
  • Employment as a commercial driver or operator of heavy or hazardous equipment.
  • Typically smoking more than 10 cigarettes or 2 cigars per day, or inability to abstain from smoking during overnight PSG visits.
  • Unwilling to use specified contraception.
  • History of regular alcohol consumption of more than 14 standard units per week (males) or more than 7 standard units per week (females), or unwillingness to limit alcohol consumption to no greater than 2 units/day (males), 1 unit per day (females), not to be consumed within 3 hours of bedtime or on PSG nights.
  • Unwilling to limit during the study period caffeinated beverage intake (e.g., coffee, cola, tea) to 400 mg/day or less of caffeine, not to be used within 3 hours of bedtime.
  • 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.
  • Participant considered by the investigator, for any reason, an unsuitable candidate to receive atomoxetine and/or dronabinol or unable or unlikely to understand or comply with the dosing schedule or study evaluations.
  • Meals and Dietary Restrictions
  • Participants should refrain from consumption of any nutrients known to modulate CYP enzyme activity (e.g., grapefruit or grapefruit juice, pomelo juice, star fruit, pomegranate, and Seville or Moro [blood] orange products) within 72 hours before the first dose of study drug and during the study.
  • Diet should be generally stable during the study, e.g., new diet programs should not be initiated.
  • Caffeine, Alcohol, and Tobacco
  • During the outpatient portions of the study, participants should refrain from more than 2 standard units per day of alcohol for men or 1 unit/day for women, consumed no less than 3 hours prior to bedtime. Alcohol should not be consumed on PSG nights.
  • Moderate consumption of caffeinated beverages, containing up to a total of 400 mg caffeine per day, is permitted during the study period, consumed no less than 3 hours prior to bedtime.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Santa Monica Clinical Trials

    Los Angeles, California, 90025

  • Clayton Sleep Institute

    St Louis, Missouri, 63143

Other trials in United States

About this study

Official title: Open-Label 4-Period Dose-Escalation Safety and Efficacy Study of AD313 in Participants With Obstructive Sleep Apnea

The SEED study is designed to assess the safety and efficacy for Obstructive Sleep Apnea (OSA) of 3 escalating dose combinations of atomoxetine with AD313 compared to baseline and to atomoxetine alone.

Read the detailed description

The SEED study is an open-label, 4 consecutive period dose-escalation study of combinations of AD313 vs. atomoxetine alone in participants with moderate- to severe OSA. A screening polysomnogram (PSG) will be conducted to establish that each participant meets study enrollment criteria and to serve as baseline. Each participant will then receive escalating doses of AD313 with on-drug PSGs to be conducted on the final night of dosing.

Being tested
Dosing 1: Atomoxetine, AD313
Keywords
Apnea, Obstructive Sleep, Sleep Apnea Syndromes, Upper Airway Reistance Syndrome
Medical subject headings
Sleep Apnea, Obstructive, Sleep Apnea Syndromes

What participants receive

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

  • Dosing 1: AtomoxetineDrug

    Also called 40mg or 80 mg Atomoxetine

    Oral administration at bedtime

  • AD313Drug

    Also called atomoxetine dronabinol

    Escalating dose of AD313; Oral administration at bedtime

Study groups in NCT05101122
Study groupRoleWhat they receive
Dosing Period 1: AtomoxetineActive comparator3 days of atomoxetine 40 mg followed by 4 days of atomoxetine 80 mg.
Receives: Drug: Dosing 1: Atomoxetine
Dosing Period 2-4: AD313ExperimentalWeek 2: atomoxetine 40 mg/dronabinol 2.5 mg Week 3: atomoxetine 80 mg/dronabinol 5 mg Week 4: atomoxetine 80 mg/dronabinol 10 mg
Receives: Drug: AD313

What is being measured

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

  1. Apnea-Hypopnea Index (AHI)4% Events Per Hour

    Compares high dose atomoxetine (80/10) versus baseline

    Measured: 28 days

Timeline

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

  1. First posted1 Nov 2021
  2. Study start19 Oct 2021
  3. Primary completion18 Apr 2022
  4. Study completion18 Apr 2022

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05101122
Sponsor's protocol ID
SEED
Acronym
SEED
Status last verified
Oct 2022
First submitted
7 Oct 2021
Last updated
7 Apr 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Messineo L, Norman D, Ojile J. The combination of atomoxetine and dronabinol for the treatment of obstructive sleep apnea: a dose-escalating, open-label trial. J Clin Sleep Med. 2023 Jul 1;19(7):1183-1190. doi: 10.5664/jcsm.10528.

    PubMed 36805833

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Dosing 1: Atomoxetine and AD313 in people with Obstructive Sleep Apnea, run by Apnimed at 2 sites in United States.

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 13 inclusion and 36 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 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Yes. Results are posted in the registry (first posted 7 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Apnea-Hypopnea Index (AHI)4% Events Per Hour (time frame: 28 days). 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 NCT05101122, 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 7 Apr 2023.

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