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

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ClinicalTrials.gov Identifier: NCT05811247
Recruitment Status : Recruiting
First Posted : April 13, 2023
Last Update Posted : November 29, 2023
Sponsor:
Information provided by (Responsible Party):
Apnimed

Study Description
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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
OSA Drug: AD109 Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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)
Actual Study Start Date : August 28, 2023
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: AD109
AD109
 Drug: AD109
Oral administration at bedtime.
Placebo Comparator: Placebo
Placebo
 Drug: Placebo
Oral administration at bedtime.


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy of AD109 on airway obstruction in mild to severe OSA [ Time Frame: 6 months ]
    Proportion of participants with reduction in AHI (AHI, average number of events for every hour of sleep), measured by polysomnography


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05811247


Contacts
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Contact: Ron Farkas, MD 6175008880 info@apnimed.com
Contact: Luigi Taranto, MD

Locations
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Sponsors and Collaborators
Apnimed
More Information
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Responsible Party: Apnimed
ClinicalTrials.gov Identifier: NCT05811247    
Other Study ID Numbers: APC-APN-304
First Posted: April 13, 2023    Key Record Dates
Last Update Posted: November 29, 2023
Last Verified: September 2023

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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