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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 : February 8, 2024
Sponsor:
Information provided by (Responsible Party):
Apnimed

Tracking Information
First Submitted Date  ICMJE March 31, 2023
First Posted Date  ICMJE April 13, 2023
Last Update Posted Date February 8, 2024
Actual Study Start Date  ICMJE August 28, 2023
Estimated Primary Completion Date June 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2023)
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
Original Primary Outcome Measures  ICMJE
 (submitted: March 31, 2023)
Efficacy of AD109 on airway obstruction in mild to severe OSA [ Time Frame: 6 months ]
Participants with reduction in AHI4
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Parallel Arm Trial of AD109 and Placebo With Patients With OSA (LunAIRo)
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE OSA
Intervention  ICMJE
  • Drug: AD109
    Oral administration at bedtime.
  • Drug: Placebo
    Oral administration at bedtime.
Study Arms  ICMJE
  • Experimental: AD109
    AD109
    Intervention: Drug: AD109
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 31, 2023)
640
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2025
Estimated Primary Completion Date June 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ron Farkas, MD 6175008880 info@apnimed.com
Contact: Luigi Taranto, MD ltaranto@apnimed.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05811247
Other Study ID Numbers  ICMJE APC-APN-304
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Apnimed
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Apnimed
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Apnimed
Verification Date September 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP