NCT05581576

Pitolisant in Refractory Restless Legs Syndrome

Open Label Assessment of Pitolisant (Wakix) as Adjunct Therapy for Patients With Refractory Restless Legs Syndrome

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: William Ondo, MD · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an open-label trial in RLS patients who have been inadequately treated with standard therapies, defined by an IRLS \> 15. This trial consists of four study center visits (weeks 0, 4, 8, and 16) and four telephone visits (weeks 1, 3, 11, and a post safety phone call at week 17). Subjects will titrate pitolisant for three weeks, starting with a dose of 8.9 mg at week 1, then increase to 17.8 mg at week 2, and a final increase to maximum dosage of 35.6 mg at week 3. If subjects are unable to tolerate the highest dose, they may reduce their dose to 17.8 mg. Titration of the drug will be monitored via telephone visits. During weeks 0-8, subjects will continue to take their current RLS medications. From week 8-16, subjects may either reduce or stop their other RLS medications as mutually agreed upon with investigator. Several questionnaire assessments will be conducted throughout the study to monitor the subjects. Subjects will complete the International RLS Rating Scale (IRLS), Restless Legs Syndrome - 6 Scale (RLS-6), RLS Quality of Life Questionnaire (RLSQoL), Fatigue Severity Scale (FSS), Hamilton Depression Scale (HDS), Montreal Cognitive Assessment (MoCA), Epworth Sleepiness Scale (ESS), Clinical Global Impressions (CGI), and Clinical Global Impressions-Change (CGI-C).

Conditions

• Restless Legs Syndrome

Interventions

Type	Name	Description
DRUG	Pitolisant	Pitolisant initial dose 8.9 mg, titrated depending on symptomatic response.

Timeline

• Start date: 2022-09-20
• Primary completion: 2023-05-01
• Completion: 2023-05-01
• First posted: 2022-10-14
• Last updated: 2022-10-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study