Pitolisant in Refractory Restless Legs Syndrome

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Restless Legs Syndrome

Intervention / Treatment
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* Drug: Pitolisant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pitolisant (Wakix)<br>Pitolisant will be titrated weekly until maximum dosage of 35.6 mg. Titration is dependent on subjects response. | Drug: Pitolisant<br>* Pitolisant initial dose 8.9 mg, titrated depending on symptomatic response.<br>* Other names: Wakix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International RLS Rating Scale (IRLS) | This is a subjective scale to measure the severity of RLS within the past week. | At week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Restless Legs Syndrome - 6 Scale (RLS-6) | This scale measures the severity of daytime versus nighttime RLS symptoms. | Baseline, 4 weeks, 8 weeks, and 16 weeks | 
| Restless Legs Syndrome Quality of Life Questionnaire (RLSQoL) | This scale assess the quality of life in RLS patients. | Baseline, 4 weeks, 8 weeks, and 16 weeks | 
| Fatigue Severity Scale (FSS) | This scale evaluates the impact of fatigue patients are experiencing. | Baseline, 4 weeks, 8 weeks, and 16 weeks | 
| Hamilton Depression Scale (HDS) | This scale assess symptoms of depression. | Baseline, 4 weeks, 8 weeks, and 16 weeks | 
| Montreal Cognitive Assessment (MoCA) | This assessment detects mild cognitive impairment. | Baseline, 4 weeks, 8 weeks, and 16 weeks | 
| Epworth Sleepiness Scale (ESS) | This is a subjective scale that measures a patient's sleepiness. | Baseline, 4 weeks, 8 weeks, and 16 weeks | 
| Clinical Global Impressions - Change | This scale assess how much a patients illness has improved or worsened when compared to a baseline state from the beginning of the intervention. | 1 week, 2 weeks, 4 weeks, 8 weeks, 11 weeks, 16 weeks, and 17 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Refractory