Ignite Creation Date:
2024-05-06 @ 1:39 PM
Last Modification Date:
2024-10-26 @ 1:18 PM
Study NCT ID:
NCT04089761
Status:
TERMINATED
Last Update Posted:
2021-02-25
First Post:
2019-09-12
Brief Title:
Safety and Efficacy of Nerivio for the Acute Treatment of Migraine in Adolescents
Sponsor:
Theranica
Organization:
Theranica
Study Overview
Official Title:
A Single Arm Open Label Multicenter Study of the Safety and Efficacy of Nerivio for the Acute Treatment of Migraine in Adolescents
Status:
TERMINATED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to the outbreak of the COVID-19 pandemic in the USA on March 2020 all study sites stopped enrolling patients to the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Nerivio is an FDA-authorized remote electrical neuromodulation REN device for the acute treatment of migraine with or without aura in patients 18 years old or above who do not have chronic migraine The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation CPM that activates a descending endogenous analgesic mechanism
This is a prospective single arm open label multicenter trial of the safety and efficacy of Nerivio for the acute treatment of migraine in adolescents
The study will be conducted in three phases
Phase I - Run-in
Phase II - Treatment phase
Phase III optional - Free-use
This is a prospective single arm open label multicenter trial of the safety and efficacy of Nerivio for the acute treatment of migraine in adolescents
The study will be conducted in three phases
Phase I - Run-in
Phase II - Treatment phase
Phase III optional - Free-use
Detailed Description:
This open label study includes 3 phases and up to 4 visits All visits will be conducted in the presence of a parentguardian
First visit - enrollment The first visit will include screening enrollment and training on the application in diary mode The screening process will include an eligibility assessment and a urine pregnancy test Following successful screening enrollment interview and signing an informed consent by the parentguardian and an informed assent by the participant The participants will be trained to use the electronic diary application installed on their own smartphones The site personnel will be required to document the training session in the CRF During this visit participants will complete baseline questionnaires that included information on the frequency and severity of their migraine attacks typical associated symptoms use of preventive and acute treatments and the effect that their migraine attacks have on their daily routine and quality of life
Phase 1 - run-in phase After the enrollment visit participants will undergo a 4-week migraine diary phase aimed to collect baseline migraine characteristics and further assess eligibility Participants will be asked to report in the application each migraine attack These reports will be transferred by the application to the electronic data collection EDC system where they will be collected and registered Participants who did not have at least 3 migraine attacks will be excluded from the study Eligibility will also be determined based on the compliance of participants to report the attacks within one hour from attack onset and report the pain level at 2 hours post-treatment in at least 667 of the reported attacks
Second visit - Device training visit Eligible participants who meet the run-in requirements will receive the Nerivio device The device will be registered and connected by Bluetooth to their smartphone During this visit participants and their parentguardian will be trained to use the device including finding the optimal individual stimulation intensity level perceptible but not painful The site will also carefully review with the patient and parentcaregiver how to identify a qualifying migraine attack see below and provide detailed instructions on study procedures
The individual intensity level identified during this visit will be recorded and the participants will be asked to treat their migraine headaches with the device using the identified intensity If the research staff recognizes that the participant cannot tolerate the feeling of the electrical stimulation the participant may be withdrawn from the study
Phase 2 -Treatment phase Participants will be instructed to use the device for the treatment of 4 qualifying migraine attacks see below as soon as possible and always within 60 minutes of onset during a period of up to 8 weeks Participants will be instructed to use the device with the intensity level identified during the device training visit with a range of 5 units and make sure the stimulation is perceptible but not painful Participants will be instructed to avoid taking rescue medications within 2 hours post-treatment If medications are used participants will be instructed to record in the app when and which medication was taken The participants will use the app to record pain intensity levels none mild moderate or severe at baseline 2- and 24-hours post-treatment and to record the presenceabsence of associated migraine symptoms nausea photophobia phonophobia at baseline and 2 hours post-treatment To assess functional disability participants will also record at baseline 2- and 24-hours post-treatment their response to the following question in their diary How do you rate your ability to do school-work or perform your usual activities using a 4-point scale as usual some ability a little ability no ability at all At the beginning of each treatment participants will also be asked to report the time elapsed from attack onset Adverse events will be reported throughout this phase of the study
Participants who do not achieve satisfactory relief at 2 hours post-treatment may treat again with the Nerivio device or may treat with usual care at that time or any time thereafter if the headache does not resolve Participants will also be able to treat headache recurrence with the device Attacks that are not treated with the device may be treated with usual care
The first reported treatment will be considered a training treatment aimed to verify that the participants use the device properly and will only be included in the safety analysis The efficacy evaluation will be performed on the first treatment of a qualifying attack see below following the training treatment hereby termed test treatment
Third visit - Termination of the treatment phase and free-use phase initiation Following the 8-week period of the treatment phase participants will return to the clinic to return the device and fill questionnaires assessing satisfaction and user experience All participants who complete the treatment phase will be offered to participate in an additional 8-week phase in which the device can be incorporate into usual care
Phase 3 - Free-use phase Participants will continue in an 8-week phase in which they will be able to use the device according to their preferences for the treatment of their migraine attacks
Fourth final visit - End of study Participants will return to the clinic following the end of the 8-week free-use phase at which time they will return the device
First visit - enrollment The first visit will include screening enrollment and training on the application in diary mode The screening process will include an eligibility assessment and a urine pregnancy test Following successful screening enrollment interview and signing an informed consent by the parentguardian and an informed assent by the participant The participants will be trained to use the electronic diary application installed on their own smartphones The site personnel will be required to document the training session in the CRF During this visit participants will complete baseline questionnaires that included information on the frequency and severity of their migraine attacks typical associated symptoms use of preventive and acute treatments and the effect that their migraine attacks have on their daily routine and quality of life
Phase 1 - run-in phase After the enrollment visit participants will undergo a 4-week migraine diary phase aimed to collect baseline migraine characteristics and further assess eligibility Participants will be asked to report in the application each migraine attack These reports will be transferred by the application to the electronic data collection EDC system where they will be collected and registered Participants who did not have at least 3 migraine attacks will be excluded from the study Eligibility will also be determined based on the compliance of participants to report the attacks within one hour from attack onset and report the pain level at 2 hours post-treatment in at least 667 of the reported attacks
Second visit - Device training visit Eligible participants who meet the run-in requirements will receive the Nerivio device The device will be registered and connected by Bluetooth to their smartphone During this visit participants and their parentguardian will be trained to use the device including finding the optimal individual stimulation intensity level perceptible but not painful The site will also carefully review with the patient and parentcaregiver how to identify a qualifying migraine attack see below and provide detailed instructions on study procedures
The individual intensity level identified during this visit will be recorded and the participants will be asked to treat their migraine headaches with the device using the identified intensity If the research staff recognizes that the participant cannot tolerate the feeling of the electrical stimulation the participant may be withdrawn from the study
Phase 2 -Treatment phase Participants will be instructed to use the device for the treatment of 4 qualifying migraine attacks see below as soon as possible and always within 60 minutes of onset during a period of up to 8 weeks Participants will be instructed to use the device with the intensity level identified during the device training visit with a range of 5 units and make sure the stimulation is perceptible but not painful Participants will be instructed to avoid taking rescue medications within 2 hours post-treatment If medications are used participants will be instructed to record in the app when and which medication was taken The participants will use the app to record pain intensity levels none mild moderate or severe at baseline 2- and 24-hours post-treatment and to record the presenceabsence of associated migraine symptoms nausea photophobia phonophobia at baseline and 2 hours post-treatment To assess functional disability participants will also record at baseline 2- and 24-hours post-treatment their response to the following question in their diary How do you rate your ability to do school-work or perform your usual activities using a 4-point scale as usual some ability a little ability no ability at all At the beginning of each treatment participants will also be asked to report the time elapsed from attack onset Adverse events will be reported throughout this phase of the study
Participants who do not achieve satisfactory relief at 2 hours post-treatment may treat again with the Nerivio device or may treat with usual care at that time or any time thereafter if the headache does not resolve Participants will also be able to treat headache recurrence with the device Attacks that are not treated with the device may be treated with usual care
The first reported treatment will be considered a training treatment aimed to verify that the participants use the device properly and will only be included in the safety analysis The efficacy evaluation will be performed on the first treatment of a qualifying attack see below following the training treatment hereby termed test treatment
Third visit - Termination of the treatment phase and free-use phase initiation Following the 8-week period of the treatment phase participants will return to the clinic to return the device and fill questionnaires assessing satisfaction and user experience All participants who complete the treatment phase will be offered to participate in an additional 8-week phase in which the device can be incorporate into usual care
Phase 3 - Free-use phase Participants will continue in an 8-week phase in which they will be able to use the device according to their preferences for the treatment of their migraine attacks
Fourth final visit - End of study Participants will return to the clinic following the end of the 8-week free-use phase at which time they will return the device
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None