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Clinical trial

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

ID
Name
APC-004
Description
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.
Trial arms
Trial start
2020-12-22
Estimated PCD
2021-05-31
Trial end
2021-05-31
Status
Completed
Phase
Early phase I
Treatment
AD109 dose1- A
Oral administration at bedtime
Arms:
Sequence ABC, Sequence ACB, Sequence BAC, Sequence BCA, Sequence CAB, Sequence CBA
Other names:
AD109 75
AD109 dose2- B
Oral administration at bedtime
Arms:
Sequence ABC, Sequence ACB, Sequence BAC, Sequence BCA, Sequence CAB, Sequence CBA
Other names:
AD109 37.5
Placebo- C
Oral administration at bedtime
Arms:
Sequence ABC, Sequence ACB, Sequence BAC, Sequence BCA, Sequence CAB, Sequence CBA
Size
32
Primary endpoint
Change in Hypoxic Burden (HB) Log Transformed - Log10HB[(%*Min)/h]
1 night (8 hours)
Change in Hypoxic Burden (HB) Raw Values - HB[(%*Min)/h]
1 night (8 hours)
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 32, 'type': 'ACTUAL'}}
Updated at
2022-12-22

1 organization

2 products

1 indication

Organization
Apnimed
Product
Placebo
Indication
Obstructive Sleep Apnea
Product
AD109