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Trial record 1 of 1 for:    NCT04645524
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Crossover Trial of AD182 and AD504 in Obstructive Sleep Apnea

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ClinicalTrials.gov Identifier: NCT04645524
Recruitment Status : Completed
First Posted : November 27, 2020
Last Update Posted : September 2, 2021
Sponsor:
Information provided by (Responsible Party):
Apnimed

Study Description
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Brief Summary:
This is a randomized, 3-period, placebo-controlled, crossover study to examine the efficacy and safety of AD182 and AD504 versus placebo in patients with obstructive sleep apnea.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Drug: AD182 Drug: AD504 Drug: Placebo Phase 2

Detailed Description:
The study is designed to examine the efficacy and safety of AD182 to treat obstructive sleep apnea. The study is a three-period single-dose randomized crossover design in which patients will undergo overnight polysomnographic (PSG) testing with dosing of one of the following 3 treatments: AD182, AD504, or Placebo. Participants will return 1 week after their final crossover PSG for an end of study (EOS) Visit.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2 Randomized, Double Blind, Placebo-Controlled, Single-Dose, 3-Period Crossover Study to Evaluate the Efficacy of AD182, and AD504 in Obstructive Sleep Apnea
Actual Study Start Date : December 1, 2020
Actual Primary Completion Date : September 1, 2021
Actual Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arms and Interventions
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Arm Intervention/treatment
Experimental: AD182
Oral capsule administered before bed
 Drug: AD182
Oral capsule administered before bed
Experimental: AD504
Oral capsule administered before bed
 Drug: AD504
Oral capsule administered before bed
Placebo Comparator: Placebo
Oral capsule administered before bed
 Drug: Placebo
Oral capsule administered before bed


Outcome Measures
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Primary Outcome Measures :
  1. Apnea-Hypopnea Index (AHI, average number of events for every hour of sleep) [ Time Frame: 1 night (treatment duration) ]
    Apnea-Hypopnea Index, AD182 and AD504 vs placebo


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female between 25 and 65 years of age, inclusive, at the time of the screening visit
  • AHI 10 to 55 events/h if meets other PSG criteria

Exclusion Criteria:

  • History of narcolepsy.
  • 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. A medication for these purposes is defined by dosage form, such that a combination antihypertensive medication is considered 1 medication
  • CPAP should not be used for at least 2 weeks prior to first study PSG
  • 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.
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): NCT04645524


Locations
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United States, Ohio
Intrepid research, LLC
Cincinnati, Ohio, United States, 45245
Sponsors and Collaborators
Apnimed
More Information
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Responsible Party: Apnimed
ClinicalTrials.gov Identifier: NCT04645524    
Other Study ID Numbers: APX-001
First Posted: November 27, 2020    Key Record Dates
Last Update Posted: September 2, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
 Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases