An interventional study of NTX100 Neuromodulation System in Restless Legs Syndrome, sponsored by Noctrix Health, Inc.. Completed at 7 sites in United States. Open to participants aged 22 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Noctrix Health, Inc. · Not applicable, Interventional, and Treatment
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
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
500 studies on the registry are indexed under Psychomotor Agitation; 55 are open to participants now.
This study's enrollment of 103 is above the median of 90 across 413 interventional studies indexed under Psychomotor Agitation.
Browse Psychomotor Agitation studies →Noctrix Health, Inc. is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
[applicable to Arm 1 only] Subject has been diagnosed with one of the following conditions:
[applicable to Arm 1 only] Subject has any of the following at or near the location of device application.
24-wks of Active neurostimulation - Noninvasive peripheral nerve stimulation device programmed to deliver active stimulation; followed by 8-wks of No Intervention
Device: NTX100 Neuromodulation System
24-wks of No Intervention
Active Noninvasive peripheral nerve stimulation device programmed to active mode
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.
Time frame: Week 24
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: Week 24
Subjects were recruited from the parent study (CT-04, RESTFUL Study). The CT-04 study enrolled 133 subjects, 126 of which completed the study. These 126 subjects were invited to participate in the CT-05 Extension study but 23 were not enrolled (7 not reachable, 12 did not consent, 1 was ineligible and 3 were unable to enroll due to a site not yet active.). This left 103 subjects that were consented and enrolled in CT-05, the Extension study.
| Milestone | Arm 1 - Direct Roll-Over Extension | Arm 2 - Control Group |
|---|---|---|
| Started | 44 | 59 |
| Completed | 41 | 55 |
| Not completed | 3 | 4 |
| Withdrew: Withdrawal by subject | 2 | 0 |
| Withdrew: Lost to follow-up | 0 | 4 |
| Withdrew: Adverse event | 1 | 0 |
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.
| Participants | Arm 1 - Direct Roll-Over Extension | Arm 2 - Control Group |
|---|---|---|
| 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. | 32 | 8 |
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.
| Participants | Arm 1 - Direct Roll-Over Extension | Arm 2 - Control Group |
|---|---|---|
| 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. | 33 | 12 |
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.
| score on a scale | Arm 1 - Direct Roll-Over Extension | Arm 2 - Control Group |
|---|---|---|
| Mean Change From Baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS) Score in Arm 1 | -11.3 ± 8.43 | -5.4 ± 6.70 |
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.
| score on a scale | Arm 1 - Direct Roll-Over Extension | Arm 2 - Control Group |
|---|---|---|
| Mean Change From Baseline in Medical Outcomes Study Sleep Problems Index II (MOS-II) Score in Arm 1 | -17.2 ± 18.81 | -6.4 ± 15.18 |
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.
| score on a scale | Arm 1 - Direct Roll-Over Extension | Arm 2 - Control Group |
|---|---|---|
| Mean Change From Baseline in Medical Outcomes Study Sleep Problems Index I (MOS-I) Score in Arm 1 | -15.8 ± 19.21 | -5.7 ± 15.48 |
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.
| Days/Week | Arm 1 - Direct Roll-Over Extension | Arm 2 - Control Group |
|---|---|---|
| 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 | -1.50 ± 1.34 | -0.41 ± 0.91 |
Collected over Up to 32 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1 | 0/44 (0%) | 0/44 (0%) | 10/44 (22.7%) |
| Arm 2 | 0/44 (0%) | 0/44 (0%) | 3/44 (6.8%) |
| Event | Arm 1 | Arm 2 |
|---|---|---|
| DiscomfortSkin and subcutaneous tissue disorders | 10/44 | 3/44 |
| Age, Continuous(years) | Arm 1 - Direct Roll-Over Extension | Arm 2 - Control Group | Total |
|---|---|---|---|
| Mean | 57.7 ± 11.65 | 57.5 ± 11.85 | 57.6 ± 11.75 |
| Sex: Female, Male(Participants) | Arm 1 - Direct Roll-Over Extension | Arm 2 - Control Group | Total |
|---|---|---|---|
| Female | 26 | 32 | 58 |
| Male | 18 | 27 | 45 |
| Ethnicity (NIH/OMB)(Participants) | Arm 1 - Direct Roll-Over Extension | Arm 2 - Control Group | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 3 | 7 |
| Not Hispanic or Latino | 40 | 52 | 92 |
| Unknown or Not Reported | 0 | 4 | 4 |
| Race (NIH/OMB)(Participants) | Arm 1 - Direct Roll-Over Extension | Arm 2 - Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 2 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 2 | 2 |
| White | 40 | 52 | 92 |
| More than one race | 4 | 3 | 7 |
| Unknown or Not Reported | 0 | 0 | 0 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Noctrix Health, Inc.