Trial Outcomes & Findings for Extension Study Evaluating NTX100 Neuromodulation System for Medication-Refractory Primary RLS (NCT NCT05196828)

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.

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

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.

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.

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.

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.

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.

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.