A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH)

Conditions

• Idiopathic Hypersomnia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• HBS-301 tablet — DRUG
  HBS-301 tablet
• Placebo — DRUG
  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 adult participants (ages ≥18 years) with idiopathic hypersomnia (IH).

Key Dates

First listed

Mar 30, 2026

Start date

Mar 16, 2026

Status verified

Sep 2026

Primary completion

Oct 31, 2027

Completion

Oct 31, 2028

Study Design

Enrollment

248 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 the end of the Double-blind Treatment Period (8 weeks) ]

Central Contacts

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

Locations (40)

Find similar trials in Birmingham, AL

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