Study of AD981 Versus Placebo in Obesity Hypoventilation Syndrome (NCT05448443) | Clinical Trial Compass
CompletedPhase 2
Study of AD981 Versus Placebo in Obesity Hypoventilation Syndrome
Italy15 participantsStarted 2022-06-21
Plain-language summary
This is a randomized, double blind, placebo-controlled, cross-over, phase II, single center efficacy study of AD981 in patients with obesity hypoventilation syndrome documented by polysomnography (PSG) and transcutaneous, overnight measurement of CO2 (PtcCO2).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Be able to understand the nature of the study and sign the informed consent
* BMI \> 35 kg/m2 and presence of nocturnal hypoventilation
* Previous surgical treatment for OSA is allowed if ≥ 1 year prior to enrollment
* If in treatment, CPAP or BPAP or mandibular advancement device or positional therapy intolerance or poor compliance
Exclusion Criteria:
* Narcolepsy, craniofacial malformation, renal failure, hepatic disease, schizophrenia, schizoaffective disorder or bipolar disorder, cognitive dysfunction, severe neurological disorder, pheochromocytoma, adrenocortical insufficiency, hyperchloremic acidosis.
* Respiratory (COPD, ILD, oxygen therapy) or cardiac (Heart Failure, Atrial fibrillation, established severe peripheral arterial disease) disease or hypertension requiring more than 3 medications for control
* Cardiomyopathies, heart malformation or structural heart alterations, severe rhythm disorders, established coronary heart disease or other cardiac conditions, which could determine sudden death
* Attempted suicide or suicidal ideation
* Drugs of abuse or substance use disorder
* A significant illness or infection requiring medical treatment in the past 30 days.
* Untreated narrow angle glaucoma.
* Women who are pregnant or nursing.
* Treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors, or monoamine oxidase inhibitors (MAOI) or linezolid within 14 days of the start of treatment, allergies to sulfonamides.
* Diabetes with unstable glu…
What they're measuring
1
Nocturnal transcutaneous CO2 pressure (PtcCO2)
Timeframe: From baseline to the last day of treatment (14 days after the start of each treatment period)