Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT04089761 |
| Other study ID # |
TCH004 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2019 |
| Est. completion date |
May 24, 2020 |
Study information
| Verified date |
June 2020 |
| Source |
Theranica |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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
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, 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 parent/guardian 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 66.7% 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 parent/guardian 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
parent/caregiver 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
presence/absence 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.
