Dataset Information

Long-term efficacy and safety of tonic motor activation for treatment of medication-refractory restless legs syndrome: A 24-Week Open-Label Extension Study.

ABSTRACT:

Study objectives

To evaluate long-term efficacy and safety of tonic motor activation (TOMAC) for treatment of medication-refractory moderate-to-severe primary restless legs syndrome (RLS).

Methods

In the parent study (RESTFUL), adults with refractory RLS were randomized to active TOMAC or sham for 4 weeks followed by 4 weeks of open-label active TOMAC. In the extension study, earlier RESTFUL completers comprised the control group (n = 59), which was followed for 24 weeks with no TOMAC intervention, and later RESTFUL completers compromised the treatment group (n = 44), which received 24 additional weeks of open-label active TOMAC followed by no intervention for 8 weeks. The primary endpoint was Clinician Global Impressions-Improvement (CGI-I) responder rate at week 24 compared to RESTFUL entry.

Results

CGI-I responder rate improved from 63.6% (95% CI, 49.4 to 77.9%) at RESTFUL completion to 72.7% (95% CI, 58.2 to 83.7%) at week 24 for the treatment group versus 13.6% (95% CI, 7.0 to 24.5%) at week 24 for the control group (p < 0.0001). Mean change in International RLS Rating Scale (IRLS) score improved from -7.4 (95% CI, -5.6 to -9.2) at RESTFUL completion to -11.3 points (95% CI, -8.8 to -13.9) at week 24 for the treatment group versus -5.4 (95% CI, -3.7 to -7.2) at week 24 for control group (p = 0.0001). All efficacy endpoints partially reverted during cessation of treatment. There were no grade 2 or higher device-related adverse events.

Conclusions

TOMAC remained safe and efficacious for >24 total weeks of treatment with partial reversion of benefits upon cessation.

Clinical trial

Extension Study Evaluating NTX100 Neuromodulation System for Medication-Refractory Primary RLS; clinicaltrials.gov/ct2/show/NCT05196828; Registered at ClinicalTrials.gov with the identifier number NCT05196828.

SUBMITTER: Roy A

PROVIDER: S-EPMC10566237 | biostudies-literature | 2023 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Long-term efficacy and safety of tonic motor activation for treatment of medication-refractory restless legs syndrome: A 24-Week Open-Label Extension Study.

Roy Asim A Ojile Joseph J Kram Jerrold J Olin Jonathan J Rosenberg Russell R Hudson J Douglas JD Bogan Richard K RK Charlesworth Jonathan D JD

Sleep 20231001 10

<h4>Study objectives</h4>To evaluate long-term efficacy and safety of tonic motor activation (TOMAC) for treatment of medication-refractory moderate-to-severe primary restless legs syndrome (RLS).<h4>Methods</h4>In the parent study (RESTFUL), adults with refractory RLS were randomized to active TOMAC or sham for 4 weeks followed by 4 weeks of open-label active TOMAC. In the extension study, earlier RESTFUL completers comprised the control group (n = 59), which was followed for 24 weeks with no T ...[more]

PMID: 37439365

Similar Datasets

Project description:IntroductionTonic motor activation (TOMAC) therapy is a novel non-pharmacologic treatment approach for patients suffering from medication-refractory restless legs syndrome (RLS). The objective of this study was to explore the potential cost-effectiveness of TOMAC in the US healthcare system.MethodsA decision-analytic Markov model was constructed to project strategy-specific treatment costs and benefits over 3 years and lifetime. Cohort characteristics (mean age 57.4 years, 39.8% male) and treatment effects were derived from the sham-controlled RESTFUL study. Study-observed International RLS Study Group (IRLS) scores were used to estimate changes in healthcare resource utilization and quality of life based on mapping algorithms informed by published data. The incremental cost-effectiveness ratio (ICER) was evaluated against established willingness-to-pay thresholds of $50,000/$150,000 per QALY to determine cost-effectiveness. Extensive scenario analyses were performed, including longer-term extension study data.Results TOMAC and sham reduced IRLS scores from baseline 25.3 to 18.10 and 21.60, respectively, at 4 weeks (treatment effect - 3.4 vs. sham), with an increase in utility from 0.80 to 0.84 (0.75-0.84 vs. baseline). Over 3 years and lifetime, the TOMAC vs. sham effect size corresponded to an added 0.10 and 0.49 QALYs (2.36 vs. 2.26; 12.59 vs. 12.10) at incremental costs of $8061 and $36,373 ($36,707 vs. $28,646; $224,040 vs.$187,667), resulting in ICER estimates of $83,822 and $73,600, respectively. Compared to baseline, TOMAC resulted in ICER estimates of $29,569 and $23,690 over 3 years and lifetime, respectively. TOMAC remained cost-effective or dominant across all scenarios, with ICERs ranging from $10,530-$83,822 and - $8061 to $29,569 vs. sham and baseline, respectively. Larger TOMAC effect sizes, achieved per extension study data, further increased cost-effectiveness.Conclusion Based on this exploratory analysis of published trial data, TOMAC therapy appears to offer meaningful improvements in patient health-related quality at net costs that render it a cost-effective intervention. Further analyses are warranted.

Dataset Information

Long-term efficacy and safety of tonic motor activation for treatment of medication-refractory restless legs syndrome: A 24-Week Open-Label Extension Study.

Study objectives

Methods

Results

Conclusions

Clinical trial

Publications

Long-term efficacy and safety of tonic motor activation for treatment of medication-refractory restless legs syndrome: A 24-Week Open-Label Extension Study.

Similar Datasets

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