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

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ClinicalTrials.gov Identifier: NCT04072380
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : September 14, 2022
Sponsor:
Information provided by (Responsible Party):
Suven Life Sciences Limited

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Narcolepsy Drug: SUVN-G3031 Drug: Placebo Phase 2

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 171 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 21, 2019
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: SUVN-G3031 2mg
Orally taken once daily for 14 days
 Drug: SUVN-G3031
SUVN-G3031 Tablets
Other Name: Samelisant
Experimental: SUVN-G3031 4mg
Orally taken once daily for 14 days
 Drug: SUVN-G3031
SUVN-G3031 Tablets
Other Name: Samelisant
Placebo Comparator: Placebo
Orally taken once daily for 14 days
 Drug: Placebo
Placebo Tablets


Outcome Measures
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Primary Outcome Measures :
  1. Maintenance of Wakefulness Test (MWT) [ Time Frame: Change from baseline in the mean MWT score at Day 14 ]
    Maintenance of Wakefulness Test (MWT) is an objective test of sleepiness that evaluates a person's ability to remain awake under soporific conditions for a defined period of time. In the MWT, time from start of the test to the time point of falling asleep will be measured, the total score can range from 0 - 30 minutes. Higher values represent a better outcome.


Secondary Outcome Measures :
  1. Clinical Global Impression of Severity (CGI-S) [ Time Frame: Change from baseline in the mean CGI-S score at Day 14 ]
    The Clinical Global Impressions of Severity (CGI-S) scale is used to rate the severity of the patient's illness by clinician, on a 7-point scale with score ranging from 1 - 7. Higher values represent a worse outcome.

  2. Epworth Sleepiness Scale (ESS) [ Time Frame: Change from baseline in the mean total ESS score at Day 14 ]
    The Epworth Sleepiness Scale (ESS) is a patient-reported questionnaire consisting of 8 questions. Each of the items are rated on a 4-point scale (0-3), based on the usual chances of dozing off or falling asleep while engaged in eight different activities. The total ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. Higher values represent a worse outcome.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04072380


Contacts
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Contact: Study Contact +9140 2319 3956 narcolepsy@suven.com

Locations
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Sponsors and Collaborators
Suven Life Sciences Limited
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Suven Life Sciences Limited
ClinicalTrials.gov Identifier: NCT04072380    
Other Study ID Numbers: CTP2S13031H3
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: September 14, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Suven Life Sciences Limited:
SUVN-G3031
Narcolepsy with and without cataplexy
Cataplexy
Narcolepsy Type 1
 Narcolepsy Type 2
Excessive Daytime Sleepiness (EDS)
Histamine H3 receptor
Samelisant
Additional relevant MeSH terms:
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Narcolepsy
Cataplexy
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
 Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders