Extension Study Evaluating NTX100 Neuromodulation System for Medication-Refractory Primary RLS
Primary Purpose
Restless Legs Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NTX100 Neuromodulation System
Sponsored by
About this trial
This is an interventional treatment trial for Restless Legs Syndrome
Eligibility Criteria
Inclusion Criteria:
- Subject previously completed the RESTFUL Study (NCT04874155).
- Subject has signed a valid, IRB-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.
Exclusion Criteria:
- [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)
- 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.
Sites / Locations
- California Center for Sleep Disorders
- Delta Waves, Inc.
- Neurotrials Research
- Clayton Sleep Institute
- Ohio Sleep Medicine Institute
- Bogan Sleep Consultants, LLC
- FutureSearch Trials of Neurology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Arm 1 - Direct Roll-Over Extension
Arm 2 - Control Group
Arm Description
24-wks of Active neurostimulation - Noninvasive peripheral nerve stimulation device programmed to deliver active stimulation; followed by 8-wks of No Intervention
24-wks of No Intervention
Outcomes
Primary Outcome Measures
Responder rate on Clinical Global Impressions-Improvement (CGI-I) scale in Arm 1
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.
Secondary Outcome Measures
Responder rate on Patient Global Impressions-Improvement (PGI-I) scale in Arm 1
Responder rate is defined as the proportion of responses of "Much Improved" or "Very Much Improved" relative to baseline on the participant-rated 7-point PGI-I scale.
Mean 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.
Mean 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.
Mean 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.
Frequency of RLS symptoms based on Question #7 in the International Restless Legs Syndrome Study Group Rating Scale (IRLS) score in Arm 1
IRLS Question #7 is a participant-rated question that measures frequency of RLS symptoms in terms of days per week.
Full Information
NCT ID
NCT05196828
First Posted
December 31, 2021
Last Updated
January 10, 2023
Sponsor
Noctrix Health, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05196828
Brief Title
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
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
December 20, 2021 (Actual)
Primary Completion Date
September 27, 2022 (Actual)
Study Completion Date
November 18, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Noctrix Health, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Restless Legs Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1 - Direct Roll-Over Extension
Arm Type
Active Comparator
Arm Description
24-wks of Active neurostimulation - Noninvasive peripheral nerve stimulation device programmed to deliver active stimulation; followed by 8-wks of No Intervention
Arm Title
Arm 2 - Control Group
Arm Type
No Intervention
Arm Description
24-wks of No Intervention
Intervention Type
Device
Intervention Name(s)
NTX100 Neuromodulation System
Intervention Description
Active Noninvasive peripheral nerve stimulation device programmed to active mode
Primary Outcome Measure Information:
Title
Responder rate on Clinical Global Impressions-Improvement (CGI-I) scale in Arm 1
Description
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.
Time Frame
Week 24 of Arm 1 relative to entry to the RESTFUL study
Secondary Outcome Measure Information:
Title
Responder rate on Patient Global Impressions-Improvement (PGI-I) scale in Arm 1
Description
Responder rate is defined as the proportion of responses of "Much Improved" or "Very Much Improved" relative to baseline on the participant-rated 7-point PGI-I scale.
Time Frame
Week 24 of Arm 1 relative to entry to the RESTFUL study
Title
Mean International Restless Legs Syndrome Study Group Rating Scale (IRLS) score in Arm 1
Description
IRLS is a participant-rated questionnaire that rates RLS severity from 0-40, where 40 is the most severe.
Time Frame
Week 24 of Arm 1 relative to entry to the RESTFUL study
Title
Mean Medical Outcomes Study Sleep Problems Index II (MOS-II) score in Arm 1
Description
MOS-II is a subscale of the participant-rated MOS questionnaire that measures subjective sleep quality.
Time Frame
Week 24 of Arm 1 relative to entry to the RESTFUL study
Title
Mean Medical Outcomes Study Sleep Problems Index I (MOS-I) score in Arm 1
Description
MOS-I is a subscale of the participant-rated MOS questionnaire that measures subjective sleep quality.
Time Frame
Week 24 of Arm 1 relative to entry to the RESTFUL study
Title
Frequency of RLS symptoms based on Question #7 in the International Restless Legs Syndrome Study Group Rating Scale (IRLS) score in Arm 1
Description
IRLS Question #7 is a participant-rated question that measures frequency of RLS symptoms in terms of days per week.
Time Frame
Week 24 of Arm 1 relative to entry to the RESTFUL study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject previously completed the RESTFUL Study (NCT04874155).
Subject has signed a valid, IRB-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.
Exclusion Criteria:
[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)
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan D Charlesworth, PhD
Organizational Affiliation
Noctrix Health, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
California Center for Sleep Disorders
City
San Leandro
State/Province
California
ZIP/Postal Code
94578
Country
United States
Facility Name
Delta Waves, Inc.
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
95125
Country
United States
Facility Name
Neurotrials Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Clayton Sleep Institute
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63123
Country
United States
Facility Name
Ohio Sleep Medicine Institute
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43017
Country
United States
Facility Name
Bogan Sleep Consultants, LLC
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
FutureSearch Trials of Neurology
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
12. IPD Sharing Statement
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Extension Study Evaluating NTX100 Neuromodulation System for Medication-Refractory Primary RLS
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