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History of Changes for Study: NCT04631107
AD109 Dose Finding in Mild to Moderate OSA
Latest version (submitted June 24, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 10, 2020 None (earliest Version on record)
2 December 10, 2020 Recruitment Status, Study Status and Contacts/Locations
3 January 11, 2021 Study Status
4 February 22, 2021 Outcome Measures and Study Status
5 February 23, 2021 Outcome Measures and Study Status
6 March 30, 2021 Recruitment Status, Study Status and Contacts/Locations
7 May 20, 2021 Study Status
8 June 24, 2021 Recruitment Status, Study Status and Study Design
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Study NCT04631107
Submitted Date:  November 10, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: APC-004
Brief Title: AD109 Dose Finding in Mild to Moderate OSA
Official Title: 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
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2020
Overall Status: Not yet recruiting
Study Start: December 2020
Primary Completion: March 2021 [Anticipated]
Study Completion: May 2021 [Anticipated]
First Submitted: November 6, 2020
First Submitted that
Met QC Criteria:
November 10, 2020
First Posted: November 17, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
November 10, 2020
Last Update Posted: November 17, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Apnimed
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Obstructive Sleep Apnea
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Crossover Assignment
Number of Arms: 3
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 30 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: AD109 dose1 Drug: AD109 dose1
Oral administration at bedtime
Experimental: AD109 dose2 Drug: AD109 dose2
Oral administration at bedtime
Placebo Comparator: Placebo Drug: Placebo
Oral administration at bedtime
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Apnea-Hypopnea Index
[ Time Frame: 1 night (8 hours) ]

AD109 dose1 and AD109 dose2 vs placebo
Open or close this module Eligibility
Minimum Age: 25 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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.
Open or close this module Contacts/Locations
Central Contact Person: Ron Farkas, MD
Telephone: 617-500-8880
Email: info@apnimed.com
Central Contact Backup: Luigi Taranto, MD
Locations: United States, California
Pacific Research Network
San Diego, California, United States, 92103
Contact:Contact: Jamie Jirik 858-649-1064 jjirik@ergclinical.com
United States, Georgia
NeuroTrial Research
Atlanta, Georgia, United States, 30328
Contact:Contact: Deondai Colquitt 404-851-9934 dcolquitt@neurotrials.com
United States, Pennsylvania
Brian Abaluck, LLC
Philadelphia, Pennsylvania, United States, 19063
Contact:Contact: Liz Roben, MD 484-888-0091 lizroben@brianabaluck.com
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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