Restless Legs Syndrome Clinical Trial
Official title:
Open Label Assessment of Pitolisant (Wakix) as Adjunct Therapy for Patients With Refractory Restless Legs Syndrome
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.
Status | Recruiting |
Enrollment | 18 |
Est. completion date | May 1, 2023 |
Est. primary completion date | May 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Houston Methodist Hospital | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
William Ondo, MD | Harmony Biosciences, LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | International RLS Rating Scale (IRLS) | This is a subjective scale to measure the severity of RLS within the past week. | At week 8 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Fatigue Severity Scale (FSS) | This scale evaluates the impact of fatigue patients are experiencing. | Baseline, 4 weeks, 8 weeks, and 16 weeks | |
Secondary | Hamilton Depression Scale (HDS) | This scale assess symptoms of depression. | Baseline, 4 weeks, 8 weeks, and 16 weeks | |
Secondary | Montreal Cognitive Assessment (MoCA) | This assessment detects mild cognitive impairment. | Baseline, 4 weeks, 8 weeks, and 16 weeks | |
Secondary | Epworth Sleepiness Scale (ESS) | This is a subjective scale that measures a patient's sleepiness. | Baseline, 4 weeks, 8 weeks, and 16 weeks | |
Secondary | 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 |
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