A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHarmony Biosciences Management, Inc.
About this trial
This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled clinical study to assess the efficacy and safety of HBS-301 in treating excessive daytime sleepiness (EDS), cataplexy, sleepiness/wakefulness, and fatigue in adult participants (ages ≥18 years) with narcolepsy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Has a current documented diagnosis of NT1 or NT2 per the International Classification of Sleep Disorders, Third Edition (ICSD-3) or the ICSD-3 Text Revision (ICSD-3-TR) within the last 10 years.
Has EDS.
If taking a permitted chronic concomitant medication or supplement, including nonprohibited antidepressants or wake-promoting agents, must be on a stable dose for at least 3 months prior to Screening and agree to continue at that stable dose for the Double-blind Treatment Period of the study. As needed (PRN) use of any treatment that could affect daytime sleepiness (including but not limited to oxybates, stimulants, modafinil, and armodafinil) is not permitted.
Disqualifiers
Has hypersomnia due to another medical disorder.
Has a history of pitolisant use within 5 half-lives prior to Screening.
Has a primary diagnosis of psychiatric illness, including depression, that is not well controlled (i.e., symptoms and medications have not been stable for at least 3 months prior to Screening).
Has any history of bipolar disorder or psychosis
Trial design
Design model
Parallel
Treatments tested in this trial
HBS-301
DrugHBS-301 tablet
Placebo
Other interventionPlacebo tablet
Treatment groups
258 Participants
are divided into 3 treatment groupsGroup A: Double-Blind Treatment Period HBS-301Experimental treatment 1 intervention
Group B: Double-blind Treatment Period PlaceboPlacebo comparator 1 intervention
Group C: Open-Label Extension Period HBS-301Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in severity of EDS as measured by the Epworth Sleepiness Scale (ESS)
The ESS is an 8-item, 4-point rating scale.
Time frame
Baseline to end of Double-Blind Treatment Period (8 weeks)Secondary outcomes
1
Change in Weekly Rate of Cataplexy (WRC) in participants with an average WRC of ≥3 over 2 consecutive weeks at Screening
The WRC is the average number of cataplexy attacks per week.
Time frame
End of the Double-Blind Treatment Period (8 weeks)2
Change in sleepiness/wakefulness measured by the Maintenance of Wakefulness Test (MWT)
The MWT consists of a series of 20-minute to 40-minute trials spaced 2 hours apart and is used to measure an individual's ability to stay awake.
Time frame
Baseline to the end of the Double-blind Treatment Period (8 weeks)3
Change in fatigue as measured by the Patient-Reported Outcomes Measurement Information System Fatigue Short Form 7a (PROMIS-Fatigue-SF-7a)
The PROMIS-Fatigue-SF-7a is a 7-question, 5-point scale used to assess fatigue.
Time frame
Baseline to end of Double-Blind Treatment Period (8 weeks)4
Change in severity of EDS as measured by the ESS
The ESS is an 8-item, 4-point rating scale.
Time frame
Baseline through Week 1 and through Week 2 of Titration Period (1 week and 2 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov