Harmony Biosciences Management, Inc.
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).
This is a Phase 3, open-label study evaluating the long-term safety of pitolisant in approximately 150 participants with Prader-Willi syndrome who have completed participation in qualifying parent studies (HBS-101-CL-002 \[OLE\], HBS-101-CL-004, or HBS-101-CL-312 \[OLE\]). Safety assessments will be conducted every 6 months. This study is open to participants from the qualified parent studies who were enrolled at US sites only.
Inclusion Criteria: Each participant must meet the following criteria to be enrolled in this study: 1. Ability to provide voluntary, written informed consent (participant, if applicable, or parent\[s\]/legal guardian\[s\]) and, where applicable, voluntary, written assent (participant, as appropriate). 2. Completion of an EOT visit in one of the following parent studies with pitolisant: HBS-101-CL-002 (OLE), HBS-101-CL-004, or HBS-101-CL-312 (OLE). Note: The parent study EOT visit may be completed after the participant completes screening for study HBS-101-CL-314 to allow for continuation…
* Pitolisant 4.45 mg tablets * Pitolisant 17.8 mg tablets
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