Restless Legs SyndromePhase 4NCT05581576
Pitolisant in Refractory Restless Legs Syndrome
A Phase 4 study testing Pitolisant in people with Restless Legs Syndrome, run by William Ondo, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Restless Legs Syndrome
- What is being tested?
- Pitolisant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2022to 1 May 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
Shivani M Desai, BS, 713-363-8390, sdesai5@houstonmethodist.org
About this study
Official title: Open Label Assessment of Pitolisant (Wakix) as Adjunct Therapy for Patients With Refractory Restless Legs Syndrome
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.
Read the 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).
- Conditions
- Restless Legs Syndrome
- Being tested
- Pitolisant
- Keywords
- Refractory
- Medical subject headings
- Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PitolisantDrug
Also called Wakix
Pitolisant initial dose 8.9 mg, titrated depending on symptomatic response.
| Study group | Role | What they receive |
|---|---|---|
| Pitolisant (Wakix) | Experimental | Pitolisant will be titrated weekly until maximum dosage of 35.6 mg. Titration is dependent on subjects response. Receives: Drug: Pitolisant |
What is being measured
The primary outcome is the main question the study is designed to answer.
International RLS Rating Scale (IRLS)
This is a subjective scale to measure the severity of RLS within the past week.
Measured: At week 8
Secondary outcomes (7)
The Restless Legs Syndrome - 6 Scale (RLS-6)
This scale measures the severity of daytime versus nighttime RLS symptoms.
Measured: Baseline, 4 weeks, 8 weeks, and 16 weeks
Restless Legs Syndrome Quality of Life Questionnaire (RLSQoL)
This scale assess the quality of life in RLS patients.
Measured: Baseline, 4 weeks, 8 weeks, and 16 weeks
Fatigue Severity Scale (FSS)
This scale evaluates the impact of fatigue patients are experiencing.
Measured: Baseline, 4 weeks, 8 weeks, and 16 weeks
Hamilton Depression Scale (HDS)
This scale assess symptoms of depression.
Measured: Baseline, 4 weeks, 8 weeks, and 16 weeks
Montreal Cognitive Assessment (MoCA)
This assessment detects mild cognitive impairment.
Measured: Baseline, 4 weeks, 8 weeks, and 16 weeks
Epworth Sleepiness Scale (ESS)
This is a subjective scale that measures a patient's sleepiness.
Measured: Baseline, 4 weeks, 8 weeks, and 16 weeks
Clinical Global Impressions - Change
This scale assess how much a patients illness has improved or worsened when compared to a baseline state from the beginning of the intervention.
Measured: 1 week, 2 weeks, 4 weeks, 8 weeks, 11 weeks, 16 weeks, and 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start20 Sep 2022
- Primary completion1 May 2023 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restless Legs SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- William Ondo, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Harmony Biosciences Management, Inc.
- Responsible party
- Sponsor-investigator, William Ondo, MD, The Methodist Hospital Research Institute
- Investigators
- William Ondo, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05581576
- Sponsor's protocol ID
- PRO00033508
- Status last verified
- Oct 2022
- First submitted
- 1 Sep 2022
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Assessment of Pitolisant (Wakix) as Adjunct Therapy for Patients With Refractory Restless Legs Syndrome
- ClinicalTrials.gov ID
- NCT05581576
- Acronym / sponsor ID
- PRO00033508
- Conditions
- Restless Legs Syndrome
- Keywords
- Refractory
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- William Ondo, MDUniversity, hospital or other
- Collaborators
- Harmony Biosciences Management, Inc.
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 14 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pitolisant (Wakix) | Experimental | Drug: PitolisantPitolisant will be titrated weekly until maximum dosage of 35.6 mg. Titration is dependent on subjects response. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PitolisantAlso: WakixPitolisant initial dose 8.9 mg, titrated depending on symptomatic response. | Drug | Pitolisant (Wakix) |
Primary outcome
International RLS Rating Scale (IRLS)
Time frame: At week 8
This is a subjective scale to measure the severity of RLS within the past week.
7 secondary outcomes
The Restless Legs Syndrome - 6 Scale (RLS-6)
Time frame: Baseline, 4 weeks, 8 weeks, and 16 weeks
Restless Legs Syndrome Quality of Life Questionnaire (RLSQoL)
Time frame: Baseline, 4 weeks, 8 weeks, and 16 weeks
Fatigue Severity Scale (FSS)
Time frame: Baseline, 4 weeks, 8 weeks, and 16 weeks
Hamilton Depression Scale (HDS)
Time frame: Baseline, 4 weeks, 8 weeks, and 16 weeks
Montreal Cognitive Assessment (MoCA)
Time frame: Baseline, 4 weeks, 8 weeks, and 16 weeks
Epworth Sleepiness Scale (ESS)
Time frame: Baseline, 4 weeks, 8 weeks, and 16 weeks
Clinical Global Impressions - Change
Time frame: 1 week, 2 weeks, 4 weeks, 8 weeks, 11 weeks, 16 weeks, and 17 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Ondo, MD principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pitolisant in people with Restless Legs Syndrome, run by William Ondo, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact William Ondo, MD (7133638184, wondo@houstonmethodist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International RLS Rating Scale (IRLS) (time frame: At week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2022.