A Phase 2, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of 2 mg and 4 mg SUVN-G3031 Compared to Placebo in Patients With Narcolepsy With and Without Cataplexy (SUVN-G3031)

  • STATUS
    Recruiting
  • End date
    Apr 17, 2023
  • participants needed
    171
  • sponsor
    Suven Life Sciences Limited
Updated on 17 September 2022
body mass index
urine drug screen
experimental drug
sleep disorder
cataplexy
multiple sleep latency test
sleep latency test
na-1

Summary

This study is of an investigational drug called SUVN-G3031 (Samelisant) 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.

Description

This is a Phase 2, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of SUVN-G3031 compared to placebo in participants with narcolepsy with and without cataplexy. Participants will be randomized at a ratio of 1:1:1 to 2 mg SUVN-G3031, 4 mg SUVN-G3031, or placebo. Each participant will receive study drug once daily, in a tablet formulation, for 14 days.

Details
Condition Narcolepsy
Treatment Placebo, SUVN-G3031
Clinical Study IdentifierNCT04072380
SponsorSuven Life Sciences Limited
Last Modified on17 September 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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