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Histamine H3 Receptor Antagonist

Pitolisant in Refractory Restless Legs Syndrome

Phase 4
Waitlist Available
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
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial is testing Pitolisant, a medication that may help improve symptoms of Restless Legs Syndrome (RLS). It targets patients who haven't found relief with standard treatments. The drug works by balancing brain chemicals that affect wakefulness and alertness.

Eligible Conditions
  • Restless Legs Syndrome
  • Restless Leg 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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

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
8 Previous Clinical Trials
2,000 Total Patients Enrolled
~6 spots leftby Dec 2025
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