Measuring Atomoxetine and Aroxybutynin In Patients With OSA

Obstructive Sleep Apnea (OSA) Clinical Trial

— MARIPOSA  

Official title:

Phase 2 Randomized Double-Blind Placebo-Controlled Parallel-Arm Dose Finding Study to Compare Fixed Dose Combinations of Atomoxetine/Aroxybutynin (AD109) to Atomoxetine Alone or Placebo in Obstructive Sleep Apnea

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04939168
• Other study ID #: APC-005
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 30, 2021
• Est. completion date: April 1, 2022

Study information

• Verified date: June 2021
• Source: Apnimed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

MARIPOSA is a randomized, double blind, placebo-controlled, parallel-arm 1-month study of AD109 in participants with OSA. Enrolled participants will be randomized to one of 5 parallel treatment arms.

Description:

MARIPOSA is a randomized, double blind, placebo-controlled, parallel-arm 1-month study in participants with OSA. A screening visit and polysomnograms (PSGs) will be conducted to establish that each participant meets study enrollment criteria. The screening PSGs will serve as the baseline for the PSGs conducted during the 3rd and 4th weeks of drug treatment. Enrolled participants will be randomized to one of 5 parallel treatment arms. The first week of dosing will be with a lower dose run-in of AD109 (or corresponding single-drug component or placebo), followed by the full dose taken in weeks 2-4. One combination tablet is taken each night immediately before lights out. A total of approximately 260 participants will be enrolled.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 260
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Between 18 to 65 years of age for men and 75 for women, inclusive

• AHI between 10 to 45 with <25% events central or mixed apneas

• BMI between 18.5 and 38 kg/m2

Exclusion Criteria:

• Current clinically significant sleep disorder other than OSA

• Clinically significant craniofacial malformation or grade =3 tonsillar hypertrophy.

• Clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or hypertension requiring more than 2 drugs for control (combination drugs count as 1 drug).

• Clinically significant neurological disorder, including epilepsy/convulsions.

• History of clinically significant urinary retention, gastric retention or other severe decreased gastrointestinal motility condition

• Severe or frequent gastroesophageal reflux or constipation

• 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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea (OSA)
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• AD109 (atomoxetine/aroxybutynin)
Matching (blinded) formulated AD109 oral tablet administered before sleep
• Atomoxetine Hydrochloride
Matching (blinded) formulated atomoxetine oral tablet administered before sleep
• Placebo
Matching (blinded) formulated placebo oral tablet administered before sleep

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Apnimed

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in AHI (4% definition)	Change in Apnea-Hypopnea Index, AD109 Dose 1 vs. Placebo	1 month
Secondary	Change in AHI (4% definition)	Change in Apnea-Hypopnea Index, AD109 Dose 2 vs. Placebo	1 month
Secondary	Change in AHI (4% definition)	Change in Apnea-Hypopnea Index, AD109 Dose 3 vs. Placebo	1 month
Secondary	Change in HB	Change in Hypoxic Burden, AD109 Dose 1 vs. Placebo	1 month