Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06180577 |
| Other study ID # |
RWE007 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 20, 2023 |
| Est. completion date |
January 20, 2024 |
Study information
| Verified date |
December 2023 |
| Source |
Theranica |
| Contact |
Dagan Harris, PhD |
| Phone |
+972-73-3703649 |
| Email |
daganh[@]theranica.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This is a retrospective survey-study to assess the accessibility, preference, and frequency
of adolescents using Nerivio by itself, in combination with pharmacological medications, or
not at all, in the school setting. The study population is prescribed Nerivio users, under
the age of 18 years old, who have used the Nerivio device at least once. The study will be
conducted electronically, and will include eligibility questions, an electronic informed
consent form signed by the parent/legal guardian (e-ICF), an assent form signed by the
adolescent patient (e-Assent), and an e-survey relating to the management of headaches due to
migraine attacks. Participants will be recruited from Nerivio's userbase and will be
compensated for their participation.
Description:
This is a retrospective survey-study to assess the accessibility, preference, and frequency
of adolescents using Nerivio by itself, in combination with pharmacological medications, or
not at all, in the school setting. The study population is prescribed Nerivio users, under
the age of 18 years old, who have used the Nerivio device at least once.
Study group: Participants will be recruited from Nerivio's user database. An invitation
message will be sent via emails and/or in-app notifications to Nerivio users who are (1)
under the age of 18 years old, and (2) treated with Nerivio at least once. Adolescents who
meet these criteria will be invited to answer a screening questionnaire verifying
eligibility.
Adolescents who are found eligible will be offered the opportunity to participate in the
study. If they are willing, they will first be directed to an Informed Consent Form (e-ICF)
to be signed by the participant's parent/legal guardian. A copy of the completed form will be
automatically sent to the parent/legal guardian upon completion. If the parent/legal guardian
consents via the e-ICF to his/her child's participation, an electronic assent form will
follow and must be signed by the adolescent patient. A copy of the assent form will be
automatically sent to the parents and the adolescent patient. Once both electronic consent
forms are signed, the adolescent patient will be enrolled in the study and will be directed
to the study survey.
Primary outcome measures:
Percent of adolescents' who prefer treating headaches due to migraine when they are at school
with Nerivio alone, relative to other options (combination, pharmaceutical, not treating
while in school).
Secondary outcome measures:
1. - Distribution of barriers to adolescents who report the necessity to treat their
headaches due to migraine while at school, including the need to leave class for
treatment, lack of availability of treatments while at school, and time delay to treat
headaches.
2. - Distribution of treatments used by adolescents at school to treat migraine headaches
prior to being prescribed Nerivio (specific pharmaceutical agents, or not treating at
all) reflecting convergence to using Nerivio at school.
