A Study of Pitolisant in Participants With Prader-Willi Syndrome

Part of paid clinical trials in Morrisville, North Carolina.

Sponsor
Harmony Biosciences Management, Inc.
Study ID
NCT07219485
Phase
PHASE3
Status
Enrolling By Invitation

Conditions

  • Prader-Willi Syndrome

Eligibility Criteria

Sex
ALL
Age
7 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pitolisant — DRUG
    * Pitolisant 4.45 mg tablets * Pitolisant 17.8 mg tablets

Study Details

The purpose of this study is to assess safety of pitolisant in eligible participants with Prader-Willi syndrome (PWS) who completed the End of Treatment (EOT) visit in a parent study (HBS-101-CL-002 \[Open Label Extension (OLE)\], HBS- 101-CL-004, or HBS-101-CL-312 OLE).

Key Dates

Start date
Aug 20, 2025
Status verified
Mar 2026
Primary completion
Aug 31, 2030
Completion
Aug 31, 2030

Study Design

Enrollment
150 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pitolisant
    All participants receive pitolisant administered orally once daily in the morning upon awakening.

Primary Outcome Measure

Percentage of participants reporting Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: From the end of the EOT visit of the parent study through 30 days after the final dose of study drug. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Science 37MorrisvilleNorth Carolina27560-

Find similar trials in Morrisville, NC

By research site
Science 37· Morrisville, NC

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