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Pitolisant in Refractory Restless Legs Syndrome

NCT05581576 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-10-14

No results posted yet for this study

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.

Conditions

  • Restless Legs Syndrome

Interventions

DRUG

Pitolisant

Pitolisant initial dose 8.9 mg, titrated depending on symptomatic response.

Sponsors & Collaborators

  • Harmony Biosciences Management, Inc.

    collaborator INDUSTRY

  • William Ondo, MD

    lead OTHER

Principal Investigators

  • William Ondo, MD · The Methodist Hospital Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-20
Primary Completion
2023-05-01
Completion
2023-05-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05581576 on ClinicalTrials.gov