Status:
TERMINATED
Safety and Efficacy of Nerivio™ for the Acute Treatment of Migraine in Adolescents
Lead Sponsor:
Theranica
Conditions:
Acute Migraine
Eligibility:
All Genders
12-17 years
Phase:
NA
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...
Detailed Description
This open label study includes 3 phases and up to 4 visits. All visits will be conducted in the presence of a parent/guardian. First visit - enrollment: The first visit will include screening, enroll...
Eligibility Criteria
Inclusion
- 1\. Participants age 12-17 years old at the time of informed consent, inclusive. 2. Participants have at least a 6-month history of headaches that meet the ICHD-3 diagnostic criteria for migraine with or without aura 3. History of at least 3 migraine attacks per month for each of the 2 months preceding study enrolment 4. Typical headache duration of at least 3 hours (when untreated or unsuccessfully treatment) 5. Stable migraine preventive medications during the 2 months prior to enrollment (no change in usage or dosage).
- 6\. Participants have personal access to a smartphone (24/7) 7. Participants must be able and willing to comply with the protocol 8. Parents/Guardians must be able and willing to provide written informed consent 9. Participants must be able and willing to provide informed assent
Exclusion
- Participants with an implanted electrical and/or neurostimulator device (e.g. cardiac pacemaker, cochlear implant).
- Participants with congestive heart failure (CHF), severe cardiac or cerebrovascular disease.
- Participants with epilepsy.
- Medical use of cannabis or recreational use one month prior to enrollment.
- Participants who have undergone nerve block (occipital or other) in the head or neck within the last 2 weeks
- Treatment with onabotulinum toxin A (Botox) to the head and/or neck for 3 months before enrollment and/or during the study
- Any history of anti-CGRP antibody treatment
- Current participation in any other clinical study that includes treatment
- Participants without basic cognitive and motor skills required for operating a smartphone.
- Pregnant or breastfeeding females
- Pure menstrual migraine
- Participants who received parenteral treatments for migraine within the previous 2 weeks.
- Participants with other significant pain, medical or psychological problems that in the opinion of the investigator may confound the study assessments
- Participants who have previous experience with the device
- Participants with arm circumference below 7.9 inches (20 cm)
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 24 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04089761
Start Date
October 1 2019
End Date
May 24 2020
Last Update
February 25 2021
Active Locations (12)
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1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
2
Clinical Trials Solutions
Hialeah, Florida, United States, 33012
3
Nicklaus children hospital
Miami, Florida, United States, 33155
4
PANDA neurology
Atlanta, Georgia, United States, 30328