Status:
COMPLETED
Trial of AD036 in Obstructive Sleep Apnea
Lead Sponsor:
Apnimed
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
25-70 years
Phase:
PHASE2
Brief Summary
This is a randomized, double blind, placebo-controlled, repeat-dose, parallel arm, outpatient and inpatient phase 2 clinical study to examine the efficacy and safety of three dose levels of AD036 vers...
Detailed Description
This was a randomized, double-blind, placebo-controlled, repeat-dose, parallel arm, outpatient and inpatient, multicenter, dose-finding study of the combination of atomoxetine and oxybutynin in adults...
Eligibility Criteria
Inclusion
- Male participants between 25 to 65 years of age or female participants between 25 to 70 years of age.
- Key
- AHI ≥ 20 based on screening polysomnography
- Epworth Sleepiness Scale (ESS) score ≥ 4 for participants not using CPAP
- Previous surgical treatment for OSA is allowed if ≥ 1 year prior to enrollment
- Key
Exclusion
- 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.
- Clinically significant neurological disorder, including epilepsy/convulsions.
- Positive screen for drugs of abuse or substance use disorder as defined in DSM-V within 24 months prior to Screening Visit.
- A significant illness or infection requiring medical treatment in the past 30 days.
- Women who are pregnant or nursing.
- 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.
- History of using devices to affect participant sleeping position for the treatment of OSA, e.g. to discourage supine sleeping position, may enroll as long as the devices are not used during participation in the study.
- Treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors, strong cytochrome P450 2D6 (CYP2D6) inhibitors, or monoamine oxidase inhibitors (MAOI) within 14 days of the start of treatment, or concomitant with treatment.
- Use of another investigational agent within 90 days or 5 half-lives, whichever is longer, prior to dosing.
- ESS total score \> 18.
- Central apnea index \> 5/hour on baseline PSG.
- Periodic limb movement arousal index \>15/hour on baseline PSG.
- Hepatic transaminases \>3X the upper limit of normal (ULN), total bilirubin \>2X ULN (unless confirmed Gilbert syndrome), serum creatinine \>2X ULN.
- \<6 hours typical sleep duration.
- Night- or shift-work sleep schedule.
- Employment as a commercial driver or operator of heavy or hazardous equipment.
Key Trial Info
Start Date :
March 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 23 2019
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT03845023
Start Date
March 7 2019
End Date
October 23 2019
Last Update
January 17 2023
Active Locations (12)
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1
Pulmonary Associates
Glendale, Arizona, United States, 85306
2
Preferred Research Partners, Inc.
Little Rock, Arkansas, United States, 72211
3
Stanford Sleep Medicine
Redwood City, California, United States, 94063
4
SDS Clinical Trials, Inc.
Santa Ana, California, United States, 92705