Pitolisant in Refractory Restless Legs Syndrome
Open Label Assessment of Pitolisant (Wakix) as Adjunct Therapy for Patients With Refractory Restless Legs Syndrome
1 other identifier
interventional
18
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Sep 2022
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2022
CompletedStudy Start
First participant enrolled
September 20, 2022
CompletedFirst Posted
Study publicly available on registry
October 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2023
CompletedOctober 14, 2022
October 1, 2022
7 months
September 1, 2022
October 13, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
International RLS Rating Scale (IRLS)
This is a subjective scale to measure the severity of RLS within the past week.
At week 8
Secondary Outcomes (7)
The Restless Legs Syndrome - 6 Scale (RLS-6)
Baseline, 4 weeks, 8 weeks, and 16 weeks
Restless Legs Syndrome Quality of Life Questionnaire (RLSQoL)
Baseline, 4 weeks, 8 weeks, and 16 weeks
Fatigue Severity Scale (FSS)
Baseline, 4 weeks, 8 weeks, and 16 weeks
Hamilton Depression Scale (HDS)
Baseline, 4 weeks, 8 weeks, and 16 weeks
Montreal Cognitive Assessment (MoCA)
Baseline, 4 weeks, 8 weeks, and 16 weeks
- +2 more secondary outcomes
Study Arms (1)
Pitolisant (Wakix)
EXPERIMENTALPitolisant will be titrated weekly until maximum dosage of 35.6 mg. Titration is dependent on subjects response.
Interventions
Pitolisant initial dose 8.9 mg, titrated depending on symptomatic response.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- William Ondo, MDlead
- Harmony Biosciences Management, Inc.collaborator
Study Sites (1)
Houston Methodist Hospital
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William Ondo, MD
The Methodist Hospital Research Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 1, 2022
First Posted
October 14, 2022
Study Start
September 20, 2022
Primary Completion
May 1, 2023
Study Completion
May 1, 2023
Last Updated
October 14, 2022
Record last verified: 2022-10