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

Overview

About this study

Primary objective: To evaluate the effectiveness of SUVN-G3031 compared with placebo as measured by an improvement in the Maintenance of Wakefulness Test (MWT) score. Secondary objectives: To evaluate the effectiveness of SUVN-G3031 compared with placebo as measured by subjective measures including an improvement in the Clinical Global Impression of Severity (CGI-S) score related to excessive daytime sleepiness (EDS) and the change in total Epworth Sleepiness Scale (ESS) score.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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/m^2.
  • 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 (e.g., 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Lois Krahn, M.D.

Open for enrollment

Contact information:

Amanda Palacios B.S.

(480) 342-6236

Palacios.Amanda@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20513234

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