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Parallel Arm Trial of AD109 and Placebo With Patients With OSA (LunAIRo)

Sponsor
Apnimed (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05811247
Collaborator
(none)
640
Enrollment
2
Arms
23
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This is a Phase 3 Randomized Double-Blind Placebo-Controlled 1-year Parallel-Arm Study to Compare a Fixed Dose Combination of AD109 to Placebo in Obstructive Sleep Apnea.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
640 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Phase 3 Randomized Double-Blind Placebo-Controlled 1-year Parallel-Arm Study to Compare a Fixed Dose Combination of Aroxybutynin/Atomoxetine (AD109) to Placebo in Obstructive Sleep Apnea (LunAIRo Study)
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: AD109

AD109

Drug: AD109
Oral administration at bedtime.
Placebo Comparator: Placebo

Placebo

Drug: Placebo
Oral administration at bedtime.

Outcome Measures

Primary Outcome Measures

  1. Efficacy of AD109 on airway obstruction in mild to severe OSA [6 months]

    Proportion of participants with reduction in AHI (AHI, average number of events for every hour of sleep), measured by polysomnography

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. ≥18 years of age at the time of informed consent.

  2. PSG criteria: AHI of >5; ≤ 25% central or mixed apneas; and PLM arousal index ≤15

  3. PROMIS-Fatigue: raw score ≥17

  4. PAP intolerance or current PAP refusal.

  5. BMI between 18.5 and 40 kg/m2 for men, or 42 kg/m2 for women, inclusive.

Exclusion Criteria:

  1. Narcolepsy, restless leg syndrome, REM sleep behavior disorder

  2. Insomnia disorder characterized by difficulty initiating or maintaining sleep, or use within the past month of sedative-hypnotics or other medication for the purpose of treating or avoiding insomnia symptoms.

  3. Pierre Robin, Treacher Collins, or other craniofacial malformation syndrome, or grade ≥3 tonsillar hypertrophy.

  4. Clinically significant cardiac disease, e.g., ventricular arrhythmia, untreated or unstable coronary artery disease, cardiac failure. Stable atrial arrhythmia is allowed.

  5. Neuromuscular disorder (e.g., motor neuron disease, muscular dystrophy or myopathy, myasthenic syndrome); epilepsy; Parkinson, Alzheimer, or other neurodegenerative disease.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Apnimed

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Apnimed
ClinicalTrials.gov Identifier:
NCT05811247
Other Study ID Numbers:
  • APC-APN-304
First Posted:
Apr 13, 2023
Last Update Posted:
Apr 14, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Apnimed
Obstructive Sleep Apnea

Study Results

No Results Posted as of Apr 14, 2023