Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 50 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
SUVN-G3031 2mg
Orally taken once daily for 14 days
  • Drug: SUVN-G3031
    SUVN-G3031 Tablets
Experimental
SUVN-G3031 4mg
Orally taken once daily for 14 days
  • Drug: SUVN-G3031
    SUVN-G3031 Tablets
Placebo Comparator
Placebo
Orally taken once daily for 14 days
  • Drug: Placebo
    Placebo Tablets

Recruiting Locations

Montefiore Medical Center
Bronx, New York 10467
Contact:
Mariana Figuera Losada
718-920-2880
mfiguera@montefiore.org

More Details

Status
Recruiting
Sponsor
Suven Life Sciences Limited

Study Contact

Judith Forde, RN
512-734-1155
narcolepsy@suven.com

Detailed 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. Enough participants will be screened to enable 114 patients to be enrolled (38 per treatment group).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.