AD109 Dose Finding in Mild to Moderate OSA

Apnimed

Status and phase: Completed; Phase 2

Conditions: Obstructive Sleep Apnea

Treatments: Drug: AD109 dose1- A; Drug: AD109 dose2- B; Drug: Placebo- C

Study type: Interventional

Funder types: Industry

Identifiers

NCT04631107

APC-004

Details and patient eligibility

About

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.

Full description

Participants underwent initial pre-screening to determine potential study eligibility. Participants selected for further screening had either a previous history of OSA of a severity consistent with enrollment criteria or were at high risk (e.g. as assessed by STOP-Bang Questionnaire score). Only participants who met all non polysomnography (PSG) enrollment criteria at Visit 1 were eligible for a screening PSG.

Enrollment: 32 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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32 participants in 6 patient groups

Sequence ABC

Other group

Description:

AD109 Dose 1- 75 mg (A), then AD109 Dose 2- 37.5 mg (B), then Placebo (C).

Treatment:

Drug: AD109 dose2- B

Drug: Placebo- C

Drug: AD109 dose1- A

Sequence ACB

Other group

Description:

AD109 Dose 1- 75 mg (A), then Placebo (C) then AD109 Dose 2- 37.5 mg (B)

Treatment:

Drug: AD109 dose2- B

Drug: Placebo- C

Drug: AD109 dose1- A

Sequence BAC

Other group

Description:

AD109 Dose 2- 37.5 mg (B), then AD109 Dose 1- 75 mg (A), then Placebo (C)

Treatment:

Drug: AD109 dose2- B

Drug: Placebo- C

Drug: AD109 dose1- A

Sequence BCA

Other group

Description:

AD109 Dose 2- 37.5 mg (B), then Placebo (C), then AD109 Dose 1- 75 mg (A)

Treatment:

Drug: AD109 dose2- B

Drug: Placebo- C

Drug: AD109 dose1- A

Sequence CAB

Other group

Description:

Placebo (C), then AD109 Dose 1- 75 mg (A), then AD109 Dose 2- 37.5 mg (B)

Treatment:

Drug: AD109 dose2- B

Drug: Placebo- C

Drug: AD109 dose1- A

Sequence CBA

Other group

Description:

Placebo (C), then AD109 Dose 2- 37.5 mg (B), then AD109 Dose 1- 75 mg (A)

Treatment:

Drug: AD109 dose2- B

Drug: Placebo- C

Drug: AD109 dose1- A