Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AD128 · 2 trials · 2 indications
Change from baseline AHI (events/h) measured via polysomnography between the week of investigational treatment (AD128) and the week of placebo treatment.
The percentage change of mean AHI will be compared between treatment groups.
| Arm | Type | Description |
|---|---|---|
| AD128 | EXPERIMENTAL | The study specific intervention includes per oral administration of two capsules of AD128, once daily, just before lights out, for 7 days. |
| placebo | PLACEBO_COMPARATOR | Two placebo capsules (Mannitol) will be administered for the control intervention once daily, just before light outs, for one week. |
| Treatment Group 1 | EXPERIMENTAL | AD128 for 7 days, then, after a wash-out period of 7-10 days, placebo for 7 days |
| Treatment Group 2 | EXPERIMENTAL | Placebo for 7 days, then, after a wash-out period of 7-10 days, AD128 for 7 days |
| Name | Type | Description |
|---|---|---|
| AD128 | DRUG | Oral administration of two capsules before sleep for 7 days. |
| Mannitol | DRUG | Oral administration of two capsules before sleep for 7 days. |
| Placebo | DRUG | Oral administration of two capsules before sleep for 7 days. |
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 ...