Clinical trial NCT05196828: Extension Study Evaluating NTX100 Neuromodulation System for Medication-Refractory Primary RLS
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Restless Legs Syndrome
Lead sponsor: Noctrix Health, Inc.
Sponsor class: INDUSTRY
First posted: 2022-01-19
Enrollment: 103
Sex: ALL
Minimum age (years): 22
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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

Eligibility criteria: Inclusion Criteria:

1. Subject previously completed the RESTFUL Study (NCT04874155).
2. 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.
3. \[applicable to Arm 1 only\] 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.

Exclusion Criteria:

1. \[applicable to Arm 1 only\] 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.
2. \[applicable to Arm 1 only\] 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)
   * Deep vein thrombosis
   * Multiple sclerosis
3. Subject has moderate or severe cognitive disorder or mental illness.
4. \[applicable to Arm 1 only\] Subject has known allergy to device materials, electrode gel, polyurethane foam, or lycra (or severe previous reaction to medical adhesives or bandages).
5. \[applicable to Arm 1 only\] Subject has severe edema affecting lower legs.
6. \[applicable to Arm 1 only\] Subject has any of the following at or near the location of device application.

   * Acute injury
   * Cellulitis
   * Open sores
   * Other skin condition
7. \[applicable to Arm 1 only\] Subject is on dialysis or anticipated to start dialysis while participating in the study.
8. \[applicable to Arm 1 only\] 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.
9. Subject is unable or unwilling to comply with study requirements.
10. \[applicable to Arm 1 only\] Subject is pregnant or trying to become pregnant.
11. Subject has a medical condition not listed above that may affect validity of the study as determined by the investigator.
12. \[applicable to Arm 1 only\] Subject has a medical condition not listed above that may put the subject at risk as determined by the investigator.
13. Subject was unwilling or unable to follow instructions in the RESTFUL Study, including missing 2 or more follow-up evaluations.
14. \[applicable to Arm 1 only\] Subject failed to properly operate the investigational devices during Weeks 5-8 of the RESTFUL Study.
15. \[applicable to Arm 1 only\] 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.

Primary outcomes:
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.
timeFrame: Week 24
Secondary outcomes:
measure: 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.
timeFrame: Week 24
measure: Mean Change From Baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS) Score in Arm 1
timeFrame: Week 24
measure: Mean Change From Baseline in Medical Outcomes Study Sleep Problems Index II (MOS-II) Score in Arm 1
timeFrame: Week 24
measure: Mean Change From Baseline in Medical Outcomes Study Sleep Problems Index I (MOS-I) Score in Arm 1
timeFrame: Week 24
measure: 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
timeFrame: Week 24
Other outcomes:
Locations:
city: San Leandro
country: United States
facility: California Center for Sleep Disorders
state: California
city: Colorado Springs
country: United States
facility: Delta Waves, Inc.
state: Colorado
city: Atlanta
country: United States
facility: Neurotrials Research
state: Georgia
city: Saint Louis
country: United States
facility: Clayton Sleep Institute
state: Missouri
city: Dublin
country: United States
facility: Ohio Sleep Medicine Institute
state: Ohio
city: Columbia
country: United States
facility: Bogan Sleep Consultants, LLC
state: South Carolina
city: Austin
country: United States
facility: FutureSearch Trials of Neurology
state: Texas
Study officials:
affiliation: Noctrix Health, Inc.
name: Jonathan D Charlesworth, PhD
role: STUDY_DIRECTOR
References: