NCT05581576 is a Phase 4 clinical trial of Pitolisant in Restless Legs Syndrome, sponsored by William Ondo, MD.

Who is sponsoring NCT05581576?

NCT05581576 is sponsored by William Ondo, MD.

What drugs are being tested in NCT05581576?

Interventions in NCT05581576: Pitolisant.

What condition does NCT05581576 study?

NCT05581576 studies Restless Legs Syndrome.

Is NCT05581576 still recruiting?

NCT05581576 is currently status unknown. Last updated 14 October 2022.

Last reviewed 2022-10-14 · How we verify

NCT05581576

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Pitolisant in Refractory Restless Legs Syndrome

Status unknown Phase 4 Last updated 14 October 2022

What this trial tests

Phase 4 trial testing Pitolisant in Restless Legs Syndrome in 18 participants. Status unknown.

Timeline

20 September 2022

Primary endpoint
1 May 2023

1 May 2023

Quick facts

Lead sponsor	William Ondo, MD
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	20 September 2022
Primary completion	1 May 2023
Estimated completion	1 May 2023
Sites	1 location across United States

Drugs / interventions tested

Pitolisant (PITOLISANT) — full drug profile →

Conditions studied

Restless Legs Syndrome — all drugs for Restless Legs Syndrome →

Sponsor

William Ondo, MD — full company profile →

Who can join

Adults 21 to 80, any sex, with Restless Legs Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Pitolisant

Trials testing the same drug.

NCT05458128 — A Long-Term Safety and Effectiveness Study to Evaluate Pitolisant in Adult Patients With Idiopathic Hypersomnia · Phase 3 · completed
NCT05223166 — A Clinical Study to Evaluate the Efficacy and Safety of Pitolisant in the Treatment of EDS in Patients With OSA · Phase 3 · completed
NCT04596267 — Pitolisant Effects on Alcohol Self-Administration in Heavy Drinkers · Phase 1 · terminated
NCT05536011 — WAKIX® (Pitolisant) Pregnancy Registry · recruiting
NCT04026750 — Insulin Tolerance Test Study in Patients With Type 1 Diabetes · Phase 1 · terminated

Other recruiting trials for Restless Legs Syndrome

Currently open trials in the same condition.

NCT06889324 — Efficacy of Vibration Therapy on Restless Legs Syndrome and Sleep Disturbances Among Patients Undergoing Hemodialysis · NA · active not recruiting
NCT06866132 — Response to an Investigational Device in Patients With Restless Legs Syndrome · NA · active not recruiting
NCT06684782 — Prevalence and Characteristics of Restless Leg Syndrome in Thai Patients With Parkinson's Disease · recruiting
NCT06806891 — Restless Leg Syndrome: Is There a Response to Buddhist Walking Meditation in Hemodialysis · NA · recruiting
NCT06570941 — Benefits of a Cannabidiolic Acid Topical Cream for the Treatment of Restless Leg Syndrome · Phase 1, PHASE2 · active not recruiting

Other William Ondo, MD trials

Trials by the same sponsor.

NCT05529095 — Sublingual Apomorphine in Refractory Restless Legs Syndrome · Phase 4 · unknown
NCT03229174 — Brain Perfusion & Oxygenation in Parkinson's Disease With NOH · Phase 4 · completed
NCT02509793 — A Pilot Study Assessing Impulsivity in Patients With Huntington's Disease on Xenazine (Tetrabenazine) · Phase 4 · unknown
NCT03218969 — Treatment of Restless Leg Syndrome (RLS) Augmentation With Ecopipam, a D1 Specific Antagonist · Phase 1, PHASE2 · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05581576 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by William Ondo, MD
Last refreshed: 14 October 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05581576.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing