Summary:
A Study to Evaluate Safety, and Efficacy of SUVN-G3031 in Patients With Narcolepsy With and Without Cataplexy (SUVN-G3031)
Inclusion Criteria:
- Ages of 18 to 50 years (adult), inclusive.
- Have narcolepsy with or without cataplexy (Na-1 or Na-2) based on the International Classification of Sleep Disorders (3rd edition) criteria (new or previously diagnosed).
- Have undergone an multiple sleep latency test (MSLT) within the previous 15 years showing an MSLT of ≤ 8 minutes.
- An ESS score of ≥ 12; and mean MWT time of < 12 min.
- Body mass index ranging from 18 to < 45 kg/m2
- Negative urine drug screen.
- A woman must be either not of childbearing potential or of childbearing potential practicing highly effective methods of birth control.
- Willingness to complete the study protocol with full compliance with procedures and sign an informed consent form (ICF).
Exclusion Criteria:
- Habitual wake-up time after 8 AM as assessed by sleep diary, habitual sleep time of < 6 hours, and habitual bedtime past 1 AM as determined by sleep diary entries.
- Use of any investigational therapy (including pitolisant) within the 30-day period prior to enrollment.
- Excessive caffeine (defined as > 600 mg/per day) use at least 1 week prior to baseline assessments and during the course of the trial.
- Nicotine dependence that has an effect on sleep (eg, a patient who routinely awakens at night to smoke).
- Use of concurrent medications prescribed to treat narcolepsy as specified including stimulants, antidepressants and sodium oxybate.
- Current diagnosis of or past treatment for syndromes known to cause sleep disruption or any other cause of daytime sleepiness.
- Clinically significant ECG abnormalities.
- An occupation requiring variable shift work, night shifts, or frequent overnight travel which disrupts sleep patterns.
Qualified Participants May Receive:
Compensation for time and travel for all qualified completed study vistis.