A Study of Pitolisant in Participants With Prader-Willi Syndrome
brief summary
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).
detailed description
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.
official title
An Open-Label Study to Evaluate Safety of Pitolisant in Participants With Prader-Willi Syndrome