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Pitolisant in 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.
Conditions:
🦠 Restless Legs Syndrome
🗓️ Study Start (Actual) 20 September 2022
🗓️ Primary Completion (Estimated) 1 May 2023
✅ Study Completion (Estimated) 1 May 2023
👥 Enrollment (Estimated) 18
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Houston, Texas, United States

📋 Eligibility Criteria

Description

    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: 21 Years to 80 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 1 September 2022
  • First Submitted that Met QC Criteria 13 October 2022
  • First Posted 14 October 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 13 October 2022
  • Last Update Posted 14 October 2022
  • Last Verified October 2022
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