Overview

A Study to Evaluate Safety, and Efficacy of SUVN-G3031 in Patients With Narcolepsy With and Without Cataplexy

Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
0
Participant gender:
All
Summary
This study is of an investigational drug called SUVN-G3031 as a possible treatment for narcolepsy with cataplexy or narcolepsy without cataplexy. The main purpose of this study is to learn how well the study drug works and how safe the study drug is compared to placebo.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Suven Life Sciences Limited
Criteria
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.