A Phase 3, Randomized, Double-blind, Placebo-Controlled, Efficacy and Safety Study of HBS-301 in Participants with Narcolepsy Followed by an Open-label Extension

Conditions

narcolepsy

Brief summary

Change in severity of EDS as measured by the ESS from Baseline to the end of the Double-blind Treatment Period

Detailed description

1. WRC at the end of the Double-blind Treatment Period in participants with an CCI weeks during Screening, 2. Change in sleepiness/wakefulness as measured by the MWT from Baseline to the end of the Double-blind Treatment Period, 3. Zmiana w CCI mierzona za pomocą CCI od wizyty wyjściowej do zakończenia okresu leczenia prowadzonego metodą podw. ślepej próby, 4. Change in severity of EDS as measured by the ESS from Baseline through CCI of the Titration Period, 5. Change in severity of EDS as measured by the ESS from Baseline through CCI of the Titration Period, 6. WRC at CCI of the Titration Period in participants with an CCI weeks during Screening, 7. WRC at CCI of the Titration Period in participants with an CCI weeks during Screening

Related papers

No related papers found yet.

Interventions

DRUGPitolisant

DRUGPlacebo will be provided as round

DRUGbiconvex enteric-coated tablets matching CCI of HBS-301. The CCI tablets are beige to light brown. The tablets are also debossed on 1 side with CCI.

DRUGbiconvex enteric-coated tablets matching CCI tablets of HBS-301. The CCI tablets are blue-green. he tablets are also debossed on 1 side with CCI.

DRUG"Placebo will be provided as round

DRUGbiconvex enteric-coated tablets matching CCI tablets of HBS-301. The CCI tablets are blue-violet. he tablets are also debossed on 1 side with CCI.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change in severity of EDS as measured by the ESS from Baseline to the end of the Double-blind Treatment Period	—

Secondary

Measure	Time frame
1. WRC at the end of the Double-blind Treatment Period in participants with an CCI weeks during Screening, 2. Change in sleepiness/wakefulness as measured by the MWT from Baseline to the end of the Double-blind Treatment Period, 3. Zmiana w CCI mierzona za pomocą CCI od wizyty wyjściowej do zakończenia okresu leczenia prowadzonego metodą podw. ślepej próby, 4. Change in severity of EDS as measured by the ESS from Baseline through CCI of the Titration Period, 5. Change in severity of EDS as measured by the ESS from Baseline through CCI of the Titration Period, 6. WRC at CCI of the Titration Period in participants with an CCI weeks during Screening, 7. WRC at CCI of the Titration Period in participants with an CCI weeks during Screening	—

Measure

Time frame

1. WRC at the end of the Double-blind Treatment Period in participants with an CCI weeks during Screening, 2. Change in sleepiness/wakefulness as measured by the MWT from Baseline to the end of the Double-blind Treatment Period, 3. Zmiana w CCI mierzona za pomocą CCI od wizyty wyjściowej do zakończenia okresu leczenia prowadzonego metodą podw. ślepej próby, 4. Change in severity of EDS as measured by the ESS from Baseline through CCI of the Titration Period, 5. Change in severity of EDS as measured by the ESS from Baseline through CCI of the Titration Period, 6. WRC at CCI of the Titration Period in participants with an CCI weeks during Screening, 7. WRC at CCI of the Titration Period in participants with an CCI weeks during Screening

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Outcome results

None listed