A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy

Conditions

• Cataplexy
• EDS
• Fatigue
• Narcolepsy

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• HBS-301 — DRUG
  HBS-301 tablet
• Placebo — OTHER
  Placebo tablet

Study Details

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.

Key Dates

First listed

Jun 30, 2026

Start date

Jun 4, 2026

Status verified

Aug 2026

Primary completion

Oct 31, 2027

Completion

Nov 30, 2027

Study Design

Enrollment

258 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Double-Blind Treatment Period HBS-301
  HBS-301 tablets administered once daily in the morning upon wakening
• Placebo Comparator: Double-blind Treatment Period Placebo
  Matching placebo tablets administered once daily in the morning upon wakening
• Experimental: Open-Label Extension Period HBS-301
  HBS-301 tablets administered once daily in the morning upon wakening

Primary Outcome Measure

Change in severity of EDS as measured by the Epworth Sleepiness Scale (ESS) [ Time Frame: Baseline to end of Double-Blind Treatment Period (8 weeks) ]

Central Contacts

• Michelle Manuel
  847-903-4610
  [email protected]
• Katie Wilmsen
  443-309-5556
  [email protected]

Locations (50)

Find similar trials in Birmingham, AL

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