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AD109 Dose Finding in Mild to Moderate OSA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04631107
Recruitment Status : Completed
First Posted : November 17, 2020
Last Update Posted : June 25, 2021
Sponsor:
Information provided by (Responsible Party):
Apnimed

Tracking Information
First Submitted Date  ICMJE November 6, 2020
First Posted Date  ICMJE November 17, 2020
Last Update Posted Date June 25, 2021
Actual Study Start Date  ICMJE December 22, 2020
Actual Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2021)
Change in Hypoxic Burden (HB) [ Time Frame: 1 night (8 hours) ]
Change in Hypoxic Burden (HB is calculated as the oxygen desaturation 'area under the curve' in association with individual apneas and hypopneas)
Original Primary Outcome Measures  ICMJE
 (submitted: November 10, 2020)
Apnea-Hypopnea Index [ Time Frame: 1 night (8 hours) ]
AD109 dose1 and AD109 dose2 vs placebo
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2021)
Apnea-Hypopnea Index [ Time Frame: 1 night (8 hours) ]
AD109 dose1 and AD109 dose2 vs placebo
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 AD109 Dose Finding in Mild to Moderate OSA
Official Title  ICMJE Phase 2 Randomized Double-Blind Placebo-Controlled 3-Period Single-Dose Crossover Study to Evaluate the Safety and Efficacy of Two Doses of AD-109 in Mild to Moderate Obstructive Sleep Apnea
Brief Summary This is a randomized, 3-period, placebo-controlled, crossover, phase 2 clinical study to examine the efficacy and safety of 2 doses of AD109 vs placebo in patients with mild obstructive sleep apnea.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Obstructive Sleep Apnea
Intervention  ICMJE
  • Drug: AD109 dose1
    Oral administration at bedtime
  • Drug: AD109 dose2
    Oral administration at bedtime
  • Drug: Placebo
    Oral administration at bedtime
Study Arms  ICMJE
  • Experimental: AD109 dose1
    Intervention: Drug: AD109 dose1
  • Experimental: AD109 dose2
    Intervention: Drug: AD109 dose2
  • Placebo Comparator: 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 Completed
Actual Enrollment  ICMJE
 (submitted: June 24, 2021)
32
Original Estimated Enrollment  ICMJE
 (submitted: November 10, 2020)
30
Actual Study Completion Date  ICMJE May 31, 2021
Actual Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • AHI between 5 and 20 events/h
  • PGI-S equal to or higher than 1, or one or more of the following symptoms:

    • Snoring or nightime gasping/choking
    • Daytime sleepiness, fatigue or decreased concentration
    • Nonrefreshing sleep, sleep fragmentation (including from nocturia), or morning headache
    • Irritability, decreased mood or libido

Exclusion Criteria:

  • History of narcolepsy.
  • Clinically significant craniofacial malformation.
  • Clinically significant cardiac disease (e.g. rhythm disturbances, coronary artery disease or heart failure or hypertension requiring more than 2 medications for control).
  • CPAP should not be used for at least 2 weeks prior to the study
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04631107
Other Study ID Numbers  ICMJE APC-004
Has Data Monitoring Committee No
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 March 2021

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