Effect of AD128 to Treat Obstructive Sleep Apnea

Raphael Heinzer

Status and phase: Completed; Phase 3; Phase 2

Conditions: Sleep Apnea, Obstructive

Treatments: Drug: AD128; Drug: Mannitol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04394143

2020-00315

Details and patient eligibility

About

This study evaluates the combination of two drugs (AD128), to treat obstructive sleep apnea (OSA) severity. After a baseline evaluation and during 7 days, half of the participants will randomly receive this drug combination (AD128) and the other will receive a placebo, i.e. a drug without pharmaceutical effect. Neither the participants, nor the investigators will know in which arm participants are until the end of the study. After one week of trial, an evaluation will be perform and will be follow by one week without any treatment. During the third and last week of trial, there will be a crossover of the groups, i.e. the participants of the first group who took the two drugs (AD128) during the first week will take a placebo and those who took the placebo will take the drugs combination.

Enrollment: 15 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults (>18 years and ≤ 65 years)
• New or previous diagnosis of OSA with an AHI > 15/h on a polygraphic or polysomnographic recording (Participants already treated with continuous positive airway pressure (CPAP) or mandibular advancement device can be included but a 7-days wash-out period is required before the beginning of the protocol and CPAP usage will not be possible during the whole protocol duration),
• Informed Consent as documented by signature (Appendix Informed Consent Form)

Exclusion criteria

• History of seizures,
• History of glaucoma,
• History of benign prostatic hyperplasia, organic miction disorder or urinary retention,
• Gastrointestinal disease (e.g. stenosis, occlusion, ulcerative colitis, toxic megacolon, hiatal hernia...)
• Cardiac arrhythmia,
• History of bipolar disorder,
• Use of respiratory stimulants or depressants,
• Use of Hypnotics,
• Use of Central nervous system stimulants,
• Use of Monoamine oxidase inhibitors (MAOIs) antidepressant,
• Major depressive disorder,
• Central sleep apnea representing more than 10% of all respiratory events
• Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product,
• Pregnant or breast feeding female participants or participants who intend to become pregnant during the study (However, there is no contraindication to contraception),
• Other clinically significant concomitant disease states (renal failure, hepatic dysfunction, severe cardiovascular or respiratory disease, myasthenia gravis, cerebral sclerosis),
• Known or suspected non-compliance, drug or alcohol abuse,
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
• Participation in another study with investigational drug within the 30 days preceding and during the present study
• Use or morphinic and derivatives which may influence sleep,
• Refusal to be informed in case of incidental findings.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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15 participants in 2 patient groups, including a placebo group

AD128

Experimental group

Description:

The study specific intervention includes per oral administration of two capsules of AD128, once daily, just before lights out, for 7 days.

Treatment:

Drug: AD128

placebo

Placebo Comparator group

Description:

Two placebo capsules (Mannitol) will be administered for the control intervention once daily, just before light outs, for one week.

Treatment:

Drug: Mannitol