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Histamine H3 Receptor Antagonist

Pitolisant (Wakix) for Restless Legs Syndrome

Phase 4
Recruiting
Research Sponsored by William Ondo, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week, 2 weeks, 4 weeks, 8 weeks, 11 weeks, 16 weeks, and 17 weeks
Awards & highlights

Study Summary

This trial studies if a drug can help people with Restless Legs Syndrome who haven't gotten relief from other treatments.

Eligible Conditions
  • Restless Legs Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week, 2 weeks, 4 weeks, 8 weeks, 11 weeks, 16 weeks, and 17 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week, 2 weeks, 4 weeks, 8 weeks, 11 weeks, 16 weeks, and 17 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
International RLS Rating Scale (IRLS)
Secondary outcome measures
Clinical Global Impressions - Change
Epworth Sleepiness Scale (ESS)
Fatigue Severity Scale (FSS)
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pitolisant (Wakix)Experimental Treatment1 Intervention
Pitolisant will be titrated weekly until maximum dosage of 35.6 mg. Titration is dependent on subjects response.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pitolisant
2016
Completed Phase 3
~400

Find a Location

Who is running the clinical trial?

William Ondo, MDLead Sponsor
4 Previous Clinical Trials
63 Total Patients Enrolled
2 Trials studying Restless Legs Syndrome
26 Patients Enrolled for Restless Legs Syndrome
Harmony Biosciences, LLCIndustry Sponsor
7 Previous Clinical Trials
1,900 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an eligibility criteria for participants of this trial?

"This research project requires 18 participants who are aged between 21 and 80, have a history of Restless Leg Syndrome (RLS), with an International RLS Severity Scale Score higher than 15 while taking at least one medication for the condition. Also, all medications used to manage this disorder must remain stable in the two weeks before enrollment."

Answered by AI

What is the total patient count of this research endeavor?

"Affirmative. Data hosted on clinicaltrials.gov affirms that this medical study, which was first published on September 20th 2022, is actively recruiting volunteers. 18 individuals need to be recruited from 1 clinical centre."

Answered by AI

How does the use of Pitolisant (Wakix) impact patients' well-being?

"Power's internal evaluation has given Pitolisant (Wakix) a score of 3, as this is an established intervention with approval from Phase 4 clinical trials."

Answered by AI

Is this experiment accommodating participants who are of legal age?

"In line with this trial's inclusion criteria, patients between the ages of 21 and 80 are eligible to participate."

Answered by AI

Is this investigation currently seeking participants?

"Affirmative. According to clinicaltrials.gov, this research is actively recruiting participants since its initial posting on September 20th 2022 and last alteration on October 13th 2022. 18 patients are being sought at a single locale for the experiment's duration."

Answered by AI

Who else is applying?

What state do they live in?
Indiana
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I have tried one drug and looking for a better outcome. The drug is not indicated for Restless Leg Syndrom.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Pitolisant in Refractory Restless Legs Syndrome
William Ondo, MD 2022. "Pitolisant in Refractory Restless Legs Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05581576.
~7 spots leftby May 2025
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