Pitolisant in Refractory Restless Legs Syndrome

• Status: Recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label trial in Restless Legs Syndrome (RLS) patients inadequately treated with standard therapy, defined by an IRLS score greater than 15. Investigators hypothesize that the study drug, Pitolisant (Wakix), may improve RLS symptoms.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: William Ondo, MD
• Collaborator: Harmony Biosciences, LLC

Criteria

Inclusion Criteria:

• RLS diagnosed by standard criteria with an IRLS > 15 while taking at least 1 RLS medication

• Stable RLS medications for at least 2 weeks prior to study entry

Exclusion Criteria:

• MoCA < 24

• Concurrent untreated sleep disorders, not felt to be stable

• Subjects with any significant, unstable cardiovascular, liver, lung, renal, psychiatric, or neurological diseases (not including RLS)

• Intravenous iron within 4 weeks of study entry

• Breast feeding or pregnancy determined by urine pregnancy test in subjects where pregnancy is possible (pre-menopausal, sexually active women)

• Subjects with previous allergic reaction or lack of tolerability to Pitolisant