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Clinical trial

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

NCT07675135 is registered in ClinicalTrials.gov with Harmony Biosciences Management, Inc. as lead sponsor.

NCT NCT07675135
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Registry record

As filed in ClinicalTrials.gov.

Title
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
Lead sponsor
Harmony Biosciences Management, Inc.
Phase
Phase 3
Overall status
Recruiting
Start date
June 4, 2026
Completion date
November 30, 2027
Enrollment
258 (estimated)
Sites
53

Conditions

As the registry lists them; a condition with its own page is linked.

cataplexy, eds, fatigue, narcolepsy