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A Study to Evaluate Safety, and Efficacy of SUVN-G3031 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 : October 27, 2020
Sponsor:
Information provided by (Responsible Party):
Suven Life Sciences Limited

Tracking Information
First Submitted Date  ICMJE August 26, 2019
First Posted Date  ICMJE August 28, 2019
Last Update Posted Date October 27, 2020
Actual Study Start Date  ICMJE September 21, 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 26, 2019)
Maintenance of Wakefulness Test (MWT) score [ Time Frame: Change from baseline in the mean MWT score at Day 14 ]
Improvement in the Maintenance of Wakefulness Test (MWT) score
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2019)
  • Clinical Global Impression of Severity (CGI-S) score [ Time Frame: Change from baseline in the mean CGI-S score at Day 14 ]
    Improvement in the Clinical Global Impression of Severity (CGI-S) score
  • Epworth Sleepiness Scale (ESS) score [ Time Frame: Change from baseline in the mean total ESS score at Day 14 ]
    Change in total Epworth Sleepiness Scale (ESS) score
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate Safety, and Efficacy of SUVN-G3031 in Patients With Narcolepsy With and Without Cataplexy
Official Title  ICMJE 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
Brief 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.
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Narcolepsy
Intervention  ICMJE
  • Drug: SUVN-G3031
    SUVN-G3031 Tablets
  • Drug: Placebo
    Placebo Tablets
Study Arms  ICMJE
  • Experimental: SUVN-G3031 2mg
    Orally taken once daily for 14 days
    Intervention: Drug: SUVN-G3031
  • Experimental: SUVN-G3031 4mg
    Orally taken once daily for 14 days
    Intervention: Drug: SUVN-G3031
  • Placebo Comparator: Placebo
    Orally taken once daily for 14 days
    Intervention: Drug: Placebo
Publications * Nirogi R, Mudigonda K, Bhyrapuneni G, Muddana NR, Shinde A, Goyal VK, Pandey SK, Mohammed AR, Ravula J, Jetta S, Palacharla VRC. Safety, Tolerability, and Pharmacokinetics of SUVN-G3031, a Novel Histamine-3 Receptor Inverse Agonist for the Treatment of Narcolepsy, in Healthy Human Subjects Following Single and Multiple Oral Doses. Clin Drug Investig. 2020 Jul;40(7):603-615. doi: 10.1007/s40261-020-00920-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 26, 2019)
114
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jennifer Pokorny 215-578-2563 narcolepsy@suven.com
Contact: Deb T Munson 949-202-3223
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04072380
Other Study ID Numbers  ICMJE CTP2S13031H3
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Suven Life Sciences Limited
Study Sponsor  ICMJE Suven Life Sciences Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Suven Life Sciences Limited
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP