Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT03076515 |
| Other study ID # |
TCH_002 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 2, 2017 |
| Est. completion date |
April 1, 2018 |
Study information
| Verified date |
October 2020 |
| Source |
Theranica |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This is a prospective, randomized, double-blind, sham controlled multi-center trial. Ratio
between treatment and control groups will be 1:1, stratified by center and use of preventive
medications.
Description:
This is a prospective, randomized, double-blind, sham controlled multi-center clinical trial
"Migraine Treatment with Nerivio Migra electro stimulation device". The study will enroll up
to 248 patients diagnosed with migraine with and without aura, per the inclusion and
exclusion criteria. These patients will be individually and randomly assigned to either
treatment group or control group. For sham control, short electrical pulses of amplitude
range similar to that of the treatment programs will be administered at very low frequency
(0.1-0.5 Hz). The rationale underlying selection of sham control settings is that, on the one
hand, pulses are perceivable and the user is able to manipulate their intensity similarly to
the case of treatment programs, while, on the other hand, no clinically relevant treatment is
delivered, based on existing knowledge of parameters range of electro stimulation treatments×¥
Following successful screening, enrollment interview and signing of informed consent,
participants will be provided with an active Nerivio Migra or identically looking sham device
and trained to perform treatment and provide feedback via the smartphone application. Ratio
between treatment and control groups will be 1:1.
Baseline information including mean frequency and severity of migraine attacks, occurrence of
other headaches, presence of ICHD-3 diagnostic criteria for migraine with and without aura
and use of preventive and rescue medications will be recorded.
Investigational devices will be programmed in active or sham mode with a 1:1 ratio, in order
to achieve the desired ratio between active and control groups sizes.
Stage One. In stage one (roll-in phase) recruited participants will be reporting their
migraine attacks per ICHD-3 diagnostic criteria, including presence of aura, using an
electronic migraine diary installed on their smartphones. Duration of this phase is one
month.
Participants that will report less than 2 or more than 8 migraine attacks during the roll-in
period will be excluded from the treatment phase.
Stage Two. This will be the parallel arm treatment stage. Participants will be instructed to
activate the device at onset of a qualifying migraine attack and manually adjust stimulation
intensity to a level within the pre-defined range where it is well perceived but not painful.
A qualifying migraine attack shall be preceded by at least 48 hours of freedom from headache.
Patients will be requested to refrain from use of rescue medications prior to and during the
first two hours after treatment with the device, and if they can not comply with this, record
their use of rescue medications (migraine specific drugs or other medications or therapies
that may be used to treat pain, from a pre-specified list) in the mobile application.
Via the smartphone application, each participant will be asked to rate his/her migraine pain
level three times using Pain Grades Scale (0 - no pain, 1- mild pain, 2- moderate pain, 3 -
severe pain): (1) upon starting the treatment, (2) two hours after start of treatment, (3) 48
hours after start of attack. At the start of each treatment, participants will be also asked
to provide time elapsed from start of migraine attack to start of the treatment. Participants
will be also asked to provide feedback regarding their use of medication (migraine specific
drugs or other medications or therapies that may be used to treat pain, from a pre-specified
list), presence of nausea, photophobia and phonophobia, and treatment perception. After
providing feedback at two hours after start of treatment and in case of pain recurrence,
participants will be allowed to re-treat the attack using Migra device.
Adverse events will be reported. Duration of study participation for each patient will be up
to three months, determined by one month of the roll-in stage followed treatment of four
qualifying attacks over the course of two months (whichever is achieved first).
Post study questionnaire will include patient global impression of change, blinding and
usability assessments.
Stage Three. This part will include open label extended treatment. Following the completion
of the study by all subjects and the return of all study devices, subjects will be offered a
2-month period of using active device, at no cost.
