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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06167655




Registration number
NCT06167655
Ethics application status
Date submitted
4/12/2023
Date registered
12/12/2023

Titles & IDs
Public title
A PIVOTAL STUDY EVALUATING SAFETY AND EFFICACY OF THE SHIRATRONICS MIGRAINE THERAPY SYSTEM
Scientific title
A PIVOTAL STUDY EVALUATING SAFETY AND EFFICACY OF THE SHIRATRONICS MIGRAINE THERAPY SYSTEM IN RELIEVING, INTERRUPTING, AND PREVENTING CHRONIC MIGRAINE (RELIEV-CM2)
Secondary ID [1] 0 0
STCM02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Headache Migraine Chronic 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Neurostimulator

Active comparator: High Dose -

Sham comparator: Low Dose -


Treatment: Devices: Neurostimulator
Neurostimulation system that applies stimulation to nerve pathways in the head associated with migraine symptoms.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Headache Days
Timepoint [1] 0 0
12-weeks

Eligibility
Key inclusion criteria
1. = 22 years of age.
2. Have migraine onset at = 50 years of age.
3. Have a history of migraine for = 12 months prior to screening.
4. Have 15 - 26 headache days/month, among which = 8 days has the features of probable migraine, and minimum of 2 headache-free days/month during the 28-day screening period.
5. Fulfill the criteria for chronic migraine (CM) during the 28-day screening period.
6. Have a diagnosis of refractory chronic migraine (RCM), who have inadequate response or no access to, or are intolerant, unwilling, or contraindicated to Onabotulinum toxin A (Botox) therapy, and One of the medications that belong to Calcitonin Gene Related Peptide Monoclonal antibodies (CGRP) therapy or CGRP antagonist therapy.
7. Maintain a stable use of preventive(s) migraine medication for = 3 months before screening.
8. Demonstrate = 80% compliance with the headache diary during the screening period by entering headache data on a minimum of 22 out of 28 days.
9. Be willing and able to comply with all study procedures and return to the clinic for the follow-up evaluation, as specified in this protocol.
10. Be able to give voluntary, written informed consent to participate in this study.
Minimum age
22 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Type of headache or migraine other than RCM including the following:

1. Post-traumatic headache (e.g., battlefield, accidents, etc.).
2. Regular intake of opioids (including codeine) of = 8 days in the past 3 months and during the 28-day screening/baseline phase and cannot be accounted for by another diagnosis.
3. Regular intake of Barbiturates for = 5 days/month in the past 3 months and during the 28-day screening/baseline phase and cannot be accounted for by another diagnosis.
4. Report experiencing unremitting, continuous headaches with no relief.
5. Have new daily persistent headache (NDPH) defined by iCHD-3 as persistent headache, daily from its onset, which is clearly remembered. The pain lacks characteristic features and may be migraine-like or tension-type like or have elements of both with a CM subtype.
2. History of treatments that could confound the results of the study

1. Previously implanted neurostimulator to stimulate the greater occipital and/or supraorbital nerves to treat headache.
2. Have received onabotulinumtoxinA (Botox) for any other medical or cosmetic reasons requiring injections in the head, face, or neck within 6 months prior to screening.
3. Have had any cervical radiofrequency ablation within 12 months.
4. Subjects with recent brain or facial trauma occurring less than 3 months prior to the Baseline Visit.
5. Subjects that may have received sequential multi-day in-patient parenteral infusion for the treatment of a migraine condition (e.g., status migrainosus) within the previous 2 weeks of the initiation of diary screening phase.
6. Subject has other implanted electrical stimulation device(s) or any metallic implant (excluding dental implants) including:

1. Cardiac pacemakers or defibrillators
2. Cochlear implant
3. CSF shunt
4. Surgical clip (above the shoulder line)
5. Intrathecal pumps
6. Spinal cord stimulator
7. Use of nerve blocks, acupuncture, neurostimulation and/or transcranial magnetic stimulation) for migraine within 3 months prior to screening and after receiving implant system.
8. Any pre-existing or requirement of emergent surgery/procedure that may interfere or confound the results of the study.
9. Any known requirement for an MRI scan subsequent to implant of the neurostimulator.
10. Current or history of following comorbidities:

1. Clinically significant psychiatric illnesses, including suicide attempt, or suicidal ideation with a specific plan in the past 2 years.
2. Cancer in the past 5 years, except for appropriately treated nonmelanoma skin carcinoma.
3. Have a current diagnosis or condition that presents excess risk for performing the procedure, as determined clinically by the Investigator.
4. Substance use disorder of at least moderate severe for substances such as; alcohol, recreational marijuana, or illicit drugs during the past 2 years.
11. Unable to participate or successfully complete the study, in the opinion of the investigator.
12. Anatomy not suitable for placement of the study device.
13. Are currently a study center or Sponsor employee who is directly involved in the study or the relative of such an employee.
14. Pregnant or lactating female or planning a pregnancy during participation in the study.
15. Patient with life expectancy of less than 1.5 years.
16. Currently participating in or planning to participate in other investigational drug or device studies that may interfere or confound the results of the study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/05/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/08/2026
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Genesis Research Services - Broadmeadow
Recruitment hospital [2] 0 0
CerCare - Wayville
Recruitment hospital [3] 0 0
Monash House Research Centre - Melbourne
Recruitment postcode(s) [1] 0 0
- Broadmeadow
Recruitment postcode(s) [2] 0 0
- Wayville
Recruitment postcode(s) [3] 0 0
3170 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Minnesota
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ShiraTronics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Brian Grosberg, MD
Address 0 0
Hartford Headache Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ecklund
Address 0 0
Country 0 0
Phone 0 0
1-844-228-7330
Fax 0 0
Email 0 0
fecklund@shiratronics.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06167655