Efficacy, Safety and Tolerability of Sulthiame in Patients With Obstructive Sleep Apnea (OSA)

Key Inclusion Criteria:

- OSA diagnosis according to the International Classification of Sleep Disorders -
Third Edition criteria with an AHI of ≥15 documented by PSG or polygraphy (PG).

- Currently not treated with continuous positive airway pressure (CPAP) or mandibular
advancement device (MAD) due to patient-reported:

- non-tolerability; and/or

- non-compliance; and/or

- not willing to use CPAP or MAD (treatment-naïve patients)

Key Exclusion Criteria:

- Any OSA treatment within the last 4 weeks prior to screening

- Fulfill criteria for a dominant central sleep apnea syndrome or dominant Cheyne
Stokes respiration

- Other clinically significant sleep disorder including periodic limb movement
disorder, restless leg syndrome, periodic limb movement arousal index (PLMAI) of
>15*, insomnia, parasomnia or narcolepsy

- as part of PSG baseline assessment

- Hypoventilation or hypoxemia due to chronic obstructive pulmonary disease or other
respiratory condition

- Clinically relevant craniofacial malformation

- Any upper airway surgery for OSA within the last 12 months prior to baseline

- Patients who underwent an obesity surgery within the last 2 years prior to baseline
or patients actively participating in any weight loss treatment program or use of
any weight loss medication (prescription or over-the-counter) within 1 month prior
to the first PSG night.