Restless Legs SyndromeNCT05196828

Extension Study Evaluating NTX100 Neuromodulation System for Medication-Refractory Primary RLS

A study testing NTX100 Neuromodulation System in people with Restless Legs Syndrome, run by Noctrix Health, Inc. at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Multi-center, prospective open-label extension study of noninvasive peripheral nerve stimulation (NPNS) with the NTX100 Neuromodulation System for patients with medication-refractory moderate- severe primary RLS Read more about this study

Who is it for?: Ages 22 to 80 years
Conditions the study is for: Restless Legs Syndrome
What is being tested?: NTX100 Neuromodulation System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 103 participants
Where: 7 sitesUnited States
Study dates: 20 Dec 2021to 18 Nov 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 22 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject previously completed the RESTFUL Study (NCT04874155).
Subject has signed a valid, Institutional Review Board-approved informed consent form, can understand the requirements of the study and instructions for device usage, and can converse in English.
[applicable to Arm 1 only] Subject agrees to not change dosage or schedule of any medications that are known to impact RLS symptoms during the study, including RLS medications, antidepressants, sleep medications, or sedative antihistamines.

Who cannot join

[applicable to Arm 1 only] Subject has active medical device implant anywhere in the body (including but not limited to pacemakers, spinal cord stimulators, deep brain stimulators) or metal implant at the site of study device electrode application.
[applicable to Arm 1 only] Subject has been diagnosed with one of the following conditions:
Epilepsy or other seizure disorder Current, active or acute or chronic infection other than common cold [and except for acute infections with mild symptoms]
A malignancy within the past 5 years (not including basal or squamous cell skin cancer)
Stage 4-5 chronic kidney disease or renal failure
Severe movement disorder symptoms (Parkinson's disease, Huntington's disease, dyskinesia, dystonia)

Show all 25Show fewer

Deep vein thrombosis
Multiple sclerosis
Subject has moderate or severe cognitive disorder or mental illness.
[applicable to Arm 1 only] Subject has known allergy to device materials, electrode gel, polyurethane foam, or lycra (or severe previous reaction to medical adhesives or bandages).
[applicable to Arm 1 only] Subject has severe edema affecting lower legs.
[applicable to Arm 1 only] Subject has any of the following at or near the location of device application.
Acute injury
Cellulitis
Open sores
Other skin condition
[applicable to Arm 1 only] Subject is on dialysis or anticipated to start dialysis while participating in the study.
[applicable to Arm 1 only] Subject has received another investigational device or drug within 30 days before study entry, is planning to receive another investigational device or drug during the study, or is planning to change RLS medications during the study.
Subject is unable or unwilling to comply with study requirements.
[applicable to Arm 1 only] Subject is pregnant or trying to become pregnant.
Subject has a medical condition not listed above that may affect validity of the study as determined by the investigator.
[applicable to Arm 1 only] Subject has a medical condition not listed above that may put the subject at risk as determined by the investigator.
Subject was unwilling or unable to follow instructions in the RESTFUL Study, including missing 2 or more follow-up evaluations.
[applicable to Arm 1 only] Subject failed to properly operate the investigational devices during Weeks 5-8 of the RESTFUL Study.
[applicable to Arm 1 only] Subject experienced a significantly higher than expected rate of device malfunctions in the RESTFUL Study, such that the malfunctions appeared to be directly related to the subject's pattern of use.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Neurotrials Research
Atlanta, Georgia, 30328
FutureSearch Trials of Neurology
Austin, Texas, 78731
Delta Waves, Inc.
Colorado Springs, Colorado, 95125
Bogan Sleep Consultants, LLC
Columbia, South Carolina, 29201
Ohio Sleep Medicine Institute
Dublin, Ohio, 43017
California Center for Sleep Disorders
San Leandro, California, 94578
Clayton Sleep Institute
St Louis, Missouri, 63123

Other trials in United States

About this study

Official title: Open-label Extension Study to Evaluate Longer-Duration Response to the NTX100 Neuromodulation System for Patients With Medication-Refractory Primary Restless Legs Syndrome (RLS)

Read the detailed description

This is an extension study only inviting subjects who have previously completed the RESTFUL Study (NCT04874155).

Each study subject is enrolled into one of the following Arms:

Arm 1 (Direct Roll-Over Extension): 24-week open-label NPNS followed by 8-weeks of no treatment, no delay after completion of the RESTFUL Study

Arm 2 (Control Group): 24-weeks of no treatment

Conditions: Restless Legs Syndrome
Being tested: NTX100 Neuromodulation System
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.

NTX100 Neuromodulation SystemDevice
Active Noninvasive peripheral nerve stimulation device programmed to active mode

Study groups in NCT05196828
Study group	Role	What they receive
Arm 1 - Direct Roll-Over Extension	Active comparator	24-wks of Active neurostimulation - Noninvasive peripheral nerve stimulation device programmed to deliver active stimulation; followed by 8-wks of No Intervention Receives: Device: NTX100 Neuromodulation System
Arm 2 - Control Group	No intervention	24-wks of No Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects for Which the Clinician Reported "Much Improved" or "Very Much Improved" on the Clinical Global Impressions-Improvement (CGI-I) Scale in Treatment Group (Arm 1) Relative to Baseline.
Responder rate is defined as the proportion of responses of "Much Improved" or "Very Much Improved" relative to baseline on the investigator-rated 7-point CGI-I scale. The outcomes were also evaluated as Treatment Group (Arm 1) at 24 weeks related to Control Group (Arm 2) at 24 weeks. The primary outcome, however, is the measure relative to baseline.
Measured: Week 24

Secondary outcomes (5)

Number of Subjects That Report "Much Improved" or "Very Much Improved" on the Patient Global Impressions-Improvement (PGI-I) Scale in the Treatment Group (Arm 1) Relative to Baseline.
Responder rate is defined as the proportion of responses "Much Improved" or "Very Much Improved" on the Patient Global Impressions-Improvement (PGI-I) Scale in the Treatment Group (Arm 1) Relative to Baseline. Note that the Responder Rate was be calculated relative to baseline for the endpoint but was also be calculated relative to the value for the control group at Week 24.
Measured: Week 24
Mean Change From Baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS) Score in Arm 1
IRLS is a participant-rated questionnaire that rates RLS severity from 0-40, where 40 is the most severe. Note that the IRLS score was calculated relative to baseline for the endpoint but was also be calculated relative to the value for the control group at Week 24.
Measured: Week 24
Mean Change From Baseline in Medical Outcomes Study Sleep Problems Index II (MOS-II) Score in Arm 1
MOS-II is a subscale of the participant-rated MOS questionnaire that measures subjective sleep quality. The MOS-I (6-items) and MOS-II (9-items) are the two validated subscales of the 12-item MOS Sleep Scale. Both are scored from 0 to 100, where 100 corresponds to the worst possible sleep problems and 0 corresponds to no sleep problems. See https://labs.dgsom.ucla.edu/hays/files/view/docs/surveys/sleep/sleepman-112603.pdf for more information.
Note that the mean MOS-II score was calculated relative to baseline for the endpoint but was also be calculated relative to the value for the control group at Week 24.
Measured: Week 24
Mean Change From Baseline in Medical Outcomes Study Sleep Problems Index I (MOS-I) Score in Arm 1
MOS-I is a subscale of the participant-rated MOS questionnaire that measures subjective sleep quality. The MOS-I (6-items) and MOS-II (9-items) are the two validated subscales of the 12-item MOS Sleep Scale. Both are scored from 0 to 100, where 100 corresponds to the worst possible sleep problems and 0 corresponds to no sleep problems. See https://labs.dgsom.ucla.edu/hays/files/view/docs/surveys/sleep/sleepman-112603.pdf for more information. Note that the outcome is measured relative to baseline but also relative to the Arm 2 (control group) at 24 weeks.
Measured: Week 24
Days Per Week of RLS Symptoms Based on Question #7 in the International Restless Legs Syndrome Study Group Rating Scale (IRLS) Score in Arm 1
The International Restless Legs Syndrome (IRLS) Question #7 is a participant-rated question that measures the frequency of RLS symptoms in terms of days per week.
Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Dec 202118 Nov 2022

First posted19 Jan 2022
Study start20 Dec 2021
Primary completion27 Sep 2022
Study completion18 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
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 N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 103 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05196828
Sponsor's protocol ID: CT-05
Status last verified: Aug 2024
First submitted: 31 Dec 2021
Last updated: 19 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Roy A, Ojile J, Kram J, Olin J, Rosenberg R, Hudson JD, Bogan RK, Charlesworth JD. Long-term efficacy and safety of tonic motor activation for treatment of medication-refractory restless legs syndrome: A 24-Week Open-Label Extension Study. Sleep. 2023 Oct 11;46(10):zsad188. doi: 10.1093/sleep/zsad188.
PubMed 37439365

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Restless Legs Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-label Extension Study to Evaluate Longer-Duration Response to the NTX100 Neuromodulation System for Patients With Medication-Refractory Primary Restless Legs Syndrome (RLS)
ClinicalTrials.gov ID: NCT05196828
Acronym / sponsor ID: CT-05
Conditions: Restless Legs Syndrome
Study type: Interventional
Recruitment status: Completed
Enrolment: 103 participants (actual)
Lead sponsor: Noctrix Health, Inc.Industry (pharma, biotech, devices)
Study start: 20 Dec 2021 (actual)
Primary completion: 27 Sep 2022 (actual)
Study completion: 18 Nov 2022 (actual)
First posted: 19 Jan 2022 (actual)
Results: Posted 19 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This is an extension study only inviting subjects who have previously completed the RESTFUL Study (NCT04874155).

Each study subject is enrolled into one of the following Arms:

Arm 1 (Direct Roll-Over Extension): 24-week open-label NPNS followed by 8-weeks of no treatment, no delay after completion of the RESTFUL Study

Arm 2 (Control Group): 24-weeks of no treatment

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm 1 - Direct Roll-Over Extension	Active comparator	Device: NTX100 Neuromodulation System24-wks of Active neurostimulation - Noninvasive peripheral nerve stimulation device programmed to deliver active stimulation; followed by 8-wks of No Intervention
Arm 2 - Control Group	No intervention	–24-wks of No Intervention

Who may qualify

Ages: 22 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Subject previously completed the RESTFUL Study (NCT04874155).
Subject has signed a valid, Institutional Review Board-approved informed consent form, can understand the requirements of the study and instructions for device usage, and can converse in English.
[applicable to Arm 1 only] Subject agrees to not change dosage or schedule of any medications that are known to impact RLS symptoms during the study, including RLS medications, antidepressants, sleep medications, or sedative antihistamines.

Key exclusion criteria (25 listed)

[applicable to Arm 1 only] Subject has active medical device implant anywhere in the body (including but not limited to pacemakers, spinal cord stimulators, deep brain stimulators) or metal implant at the site of study device electrode application.
[applicable to Arm 1 only] Subject has been diagnosed with one of the following conditions:
Subject has moderate or severe cognitive disorder or mental illness.
[applicable to Arm 1 only] Subject has known allergy to device materials, electrode gel, polyurethane foam, or lycra (or severe previous reaction to medical adhesives or bandages).
[applicable to Arm 1 only] Subject has severe edema affecting lower legs.

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
NTX100 Neuromodulation SystemActive Noninvasive peripheral nerve stimulation device programmed to active mode	Device	Arm 1 - Direct Roll-Over Extension

Primary outcome

Number of Subjects for Which the Clinician Reported "Much Improved" or "Very Much Improved" on the Clinical Global Impressions-Improvement (CGI-I) Scale in Treatment Group (Arm 1) Relative to Baseline.
Time frame: Week 24
Responder rate is defined as the proportion of responses of "Much Improved" or "Very Much Improved" relative to baseline on the investigator-rated 7-point CGI-I scale. The outcomes were also evaluated as Treatment Group (Arm 1) at 24 weeks related to Control Group (Arm 2) at 24 weeks. The primary outcome, however, is the measure relative to baseline.

5 secondary outcomes

Number of Subjects That Report "Much Improved" or "Very Much Improved" on the Patient Global Impressions-Improvement (PGI-I) Scale in the Treatment Group (Arm 1) Relative to Baseline.
Time frame: Week 24
Mean Change From Baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS) Score in Arm 1
Time frame: Week 24
Mean Change From Baseline in Medical Outcomes Study Sleep Problems Index II (MOS-II) Score in Arm 1
Time frame: Week 24
Mean Change From Baseline in Medical Outcomes Study Sleep Problems Index I (MOS-I) Score in Arm 1
Time frame: Week 24
Days Per Week of RLS Symptoms Based on Question #7 in the International Restless Legs Syndrome Study Group Rating Scale (IRLS) Score in Arm 1
Time frame: Week 24

Results and safety

Results posted to the registry on 19 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1 - Direct Roll-Over Extension	44	41
Arm 2 - Control Group	59	55

Primary outcome: Number of Subjects for Which the Clinician Reported "Much Improved" or "Very Much Improved" on the Clinical Global Impressions-Improvement (CGI-I) Scale in Treatment Group (Arm 1) Relative to Baseline.

Time frame: Week 24. Count of participants. Unit: Participants

Measure	Arm 1 - Direct Roll-Over Extension n = 44	Arm 2 - Control Group n = 59
Value	32	8

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 32 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1	0 of 44 (0%)	10 of 44 (22.7%)	0 of 44
Arm 2	0 of 44 (0%)	3 of 44 (6.8%)	0 of 44

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37439365Roy A, Ojile J, Kram J, Olin J, Rosenberg R, Hudson JD, Bogan RK, Charlesworth JD. Long-term efficacy and safety of tonic motor activation for treatment of medication-refractory restless legs syndrome: A 24-Week Open-Label Extension Study. Sleep. 2023 Oct 11;46(10):zsad188. doi: 10.1093/sleep/zsad188.

Related trials for Restless Legs Syndrome

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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.

Jonathan D Charlesworth, PhD study director

Noctrix Health, Inc.

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing NTX100 Neuromodulation System in people with Restless Legs Syndrome, run by Noctrix Health, Inc. at 7 sites 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 3 inclusion and 25 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: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects for Which the Clinician Reported "Much Improved" or "Very Much Improved" on the Clinical Global Impressions-Improvement (CGI-I) Scale in Treatment Group (Arm 1) Relative to Baseline. (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05196828, which also lists 1 linked publication.

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 19 Sep 2024.