Recruiting

Pitolisant

Sponsor:

William Ondo, MD

Code:

NCT05581576

Conditions

Restless Legs Syndrome

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Pitolisant

Study Details

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.

Conditions

Restless Legs Syndrome

Study ID

NCT05581576

Start date

Sep 20, 2022

Status verified date

Oct, 2022

Completion date

May 1, 2023

Anticipated

Primary completion date

May 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

18 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pitolisant (Wakix)

Pitolisant will be titrated weekly until maximum dosage of 35.6 mg. Titration is dependent on subjects response.

Interventions

Pitolisant

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

Primary outcome measure

  • International RLS Rating Scale (IRLS) [ Time Frame: At week 8 ]

Central Contacts and Locations

Central contacts

William Ondo, MD

7133638184wondo@houstonmethodist.org

Shivani M Desai, BS

7133638390sdesai5@houstonmethodist.org

Locations

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Shivani M Desai, BS

713-363-8390sdesai5@houstonmethodist.org

More Information

Sponsor

William Ondo, MD

Last update posted

Oct 14, 2022

Last verified

Oct, 2022

Keywords

  • Refractory

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by William Ondo, MD on 2022-10-14.