Pitolisant in Refractory Restless Legs Syndrome | NCT05581576

Studies
Pitolisant in Refractory Restless Legs Syndrome

NCT05581576

Sponsor

William Ondo, MD

Status

Unknown status

Last Update Posted

Oct 14, 2022Actual

Enrollment

18Estimated

Phase

Phase 4

Conditions

Restless Legs Syndrome

Interventions

Pitolisant

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 20, 2022Actual

Primary Completion Date

May 1, 2023Estimated

Completion Date

May 1, 2023Estimated

First Submitted Date

Sep 1, 2022

First Submission Date that Met QC Criteria

Oct 13, 2022

First Posted Date

Oct 14, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 13, 2022

Last Update Posted Date

Oct 14, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

William Ondo, MD, Principal Investigator, The Methodist Hospital Research InstituteSponsor-Investigator

Lead Sponsor

William Ondo, MDOTHER

Collaborators

Name	Class
Harmony Biosciences Management, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

This is an open-label trial in RLS patients who have been inadequately treated with standard therapies, defined by an IRLS > 15. This trial consists of four study center visits (weeks 0, 4, 8, and 16) and four telephone visits (weeks 1, 3, 11, and a post safety phone call at week 17).

Subjects will titrate pitolisant for three weeks, starting with a dose of 8.9 mg at week 1, then increase to 17.8 mg at week 2, and a final increase to maximum dosage of 35.6 mg at week 3. If subjects are unable to tolerate the highest dose, they may reduce their dose to 17.8 mg. Titration of the drug will be monitored via telephone visits. During weeks 0-8, subjects will continue to take their current RLS medications. From week 8-16, subjects may either reduce or stop their other RLS medications as mutually agreed upon with investigator.

Several questionnaire assessments will be conducted throughout the study to monitor the subjects. Subjects will complete the International RLS Rating Scale (IRLS), Restless Legs Syndrome - 6 Scale (RLS-6), RLS Quality of Life Questionnaire (RLSQoL), Fatigue Severity Scale (FSS), Hamilton Depression Scale (HDS), Montreal Cognitive Assessment (MoCA), Epworth Sleepiness Scale (ESS), Clinical Global Impressions (CGI), and Clinical Global Impressions-Change (CGI-C).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pitolisant (Wakix)	Experimental	Pitolisant will be titrated weekly until maximum dosage of 35.6 mg. Titration is dependent on subjects response.	Drug: Pitolisant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pitolisant	Drug	Pitolisant initial dose 8.9 mg, titrated depending on symptomatic response.	Pitolisant (Wakix)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
International RLS Rating Scale (IRLS)	This is a subjective scale to measure the severity of RLS within the past week.	At week 8

Secondary Outcomes

Measure	Description	Time Frame
The Restless Legs Syndrome - 6 Scale (RLS-6)	This scale measures the severity of daytime versus nighttime RLS symptoms.	Baseline, 4 weeks, 8 weeks, and 16 weeks
Restless Legs Syndrome Quality of Life Questionnaire (RLSQoL)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
William Ondo, MD	Contact	7133638184		wondo@houstonmethodist.org
Shivani M Desai, BS	Contact	7133638390		sdesai5@houstonmethodist.org

Overall Officials

Name	Affiliation	Role
William Ondo, MD	The Methodist Hospital Research Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Houston Methodist Hospital	Recruiting	Houston	Texas	77030	United States

Condition Browse Module

MeSH Terms

ID	Term
D012148	Restless Legs Syndrome

Ancestor Terms

ID	Term
D009422	Nervous System Diseases
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C516975	pitolisant

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided