Parallel Arm Trial of AD109 and AD504 In Patients With OSA (MARIPOSA)
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| ClinicalTrials.gov Identifier: NCT05071612 |
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Recruitment Status :
Completed
First Posted : October 8, 2021
Last Update Posted : December 12, 2022
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Sponsor:
Apnimed
Information provided by (Responsible Party):
Apnimed
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Brief Summary:
This is a phase 2 randomized double-blind placebo-controlled parallel-arm dose finding study to compare fixed dose combinations of AD109 and AD504 to atomoxetine or placebo in Obstructive Sleep Apnea.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| OSA - Obstructive Sleep Apnea | Drug: AD109 Drug: AD504 Drug: Atomoxetine Hydrochloride Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 294 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Phase 2 Randomized Double-Blind Placebo-Controlled Parallel-Arm Dose Finding Study to Compare Fixed Dose Combinations of AD109 and AD504 to Atomoxetine or Placebo in Obstructive Sleep Apnea |
| Actual Study Start Date : | November 29, 2021 |
| Actual Primary Completion Date : | July 20, 2022 |
| Actual Study Completion Date : | August 3, 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Obstructive sleep apnea
MedlinePlus related topics:
Sleep Apnea
| Arm | Intervention/treatment |
|---|---|
| Experimental: AD109 Dose 1 |
Drug: AD109
Oral administration at bedtime |
| Experimental: AD109 Dose 2 |
Drug: AD109
Oral administration at bedtime |
| Experimental: AD504 Dose 1 |
Drug: AD504
Oral administration at bedtime |
| Experimental: AD504 Dose 2 |
Drug: AD504
Oral administration at bedtime |
| Active Comparator: Atomoxetine 1 |
Drug: Atomoxetine Hydrochloride
Oral administration at bedtime |
| Active Comparator: Atomoxetine 2 |
Drug: Atomoxetine Hydrochloride
Oral administration at bedtime |
| Placebo Comparator: Placebo 1 |
Drug: Placebo
Oral administration at bedtime |
| Placebo Comparator: Placebo 2 |
Drug: Placebo
Oral administration at bedtime |
Primary Outcome Measures :
- Change in AHI, combined AD109 dose arms vs. combined placebo arms [ Time Frame: 28 Days ]Change in AHI (AHI, average number of events for every hour of sleep) measured by polysomnography
Secondary Outcome Measures :
- Change in AHI, combined AD504 dose arms vs. combined placebo arms [ Time Frame: 28 Days ]Change in AHI (AHI, average number of events for every hour of sleep) measured by polysomnography
- Change in AHI, combined atomoxetine dose arms vs. combined placebo arms [ Time Frame: 28 Days ]Change in AHI (AHI, average number of events for every hour of sleep) measured by polysomnography
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Between 18 to 65 years of age for men and 18-75 for women, inclusive, at the Screening Visit.
- Mean AHI 10 to 45 events/h, inclusive
- PGI-S: >1
Exclusion Criteria:
- Current clinically significant sleep disorder other than OSA
- 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).
- Participants with a history of using devices for OSA treatment, including CPAP, oral or nasal devices, or positional devices, may enroll as long as the devices have not been used for at least 2 weeks prior to first PSG and are not used during participation in the study
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): NCT05071612
Locations
Show 25 study locations
Sponsors and Collaborators
Apnimed
| Responsible Party: | Apnimed |
| ClinicalTrials.gov Identifier: | NCT05071612 |
| Other Study ID Numbers: |
MARIPOSA |
| First Posted: | October 8, 2021 Key Record Dates |
| Last Update Posted: | December 12, 2022 |
| Last Verified: | December 2022 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Sleep Apnea Syndromes Sleep Apnea, Obstructive Apnea Respiration Disorders Respiratory Tract Diseases Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases |
Atomoxetine Hydrochloride Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Adrenergic Agents Neurotransmitter Agents Physiological Effects of Drugs |