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

  • STATUS
    Recruiting
Updated on 23 November 2020
body mass index
urine drug screen
experimental drug
cataplexy
multiple sleep latency test
sleep latency test
na-1

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.

 

Description

Compensation for time and travel for all completed study visits.

Details
Condition Narcolepsy, Pediatric Health, Cataplexy
Clinical Study IdentifierTX228688
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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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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