Clinical Trials

Inclusion Criteria:

- Ages of 18 to 65 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 a multiple sleep latency test (MSLT) study 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 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.