Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03361423 |
Other study ID # |
TCH003 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
December 17, 2017 |
Est. completion date |
December 25, 2018 |
Study information
Verified date |
February 2019 |
Source |
Theranica |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Migraine is a common neurologic with attacks of headache and associated symptoms such as
nausea, vomiting, phono and photophobia. Migraine can lead to substantial functional
impairment.
Recent evidence suggests that electro stimulation is effective in providing relief for
chronic headaches including migraine. It is tolerable by patients and associated with no
adverse effects.
The device utilizes electro stimulation to achieve conditioned pain modulation (CPM). CPM an
stimulate endogenous analgesic mechanism. The modulatory effect is over the whole body, and
can be induced anywhere.
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.
The study objectives is to demonstrate the safety and effectiveness of the Nerivio Migra
electro stimulation device for the reduction of migraine headache during an attack of
migraine with or without aura.
The study is intended for subject with 2-8 migraine episodes per month. patients will receive
the device, either an active or a placebo type, and will be asked to use the device at home
or in any location that they will be when the migraine starts.
The study hypothesis is that electro stimulation delivered transcutaneously to the peripheral
nervous system at onset of a migraine attack significantly reduce headache pain demonstrated
by a significant difference between proportions of responders to the active treatment
stimulation in comparison to proportion of responders that will use a placebo device.
Description:
Nerivio Migra is intended for the acute treatment of migraine with or without aura in
patients 18 years of age or older. It is self-applied to the upper arm. Treatments are
self-administered by the user at the onset of a migraine attack. The device delivers extra
cephalic transcutaneous electrical stimulation below the pain threshold to the skin of the
upper arm at the onset of a migraine attack. Nerivio Migra is operated via a mobile
application.
This is a prospective, randomized, double-blind, sham controlled multi-center clinical trial
to test the ability of the Nerivio Migra neuromodulation device to relieve the patient's
migraine pain during a migraine attack. The study will enroll up to 270 patients diagnosed
with migraine with or 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, electrical pulses of similar width and intensity, but much lower frequency
compared to the active device will be administered. This sham program produces pulses that
are perceivable by the user, thus maintaining the blinding, but on the other hand do not have
therapeutic qualities, based on existing knowledge of parameters range of electro stimulation
treatments.
1. st visit - screening, enrollment and training on the application in diary mode Following
successful screening, enrollment interview and signing of informed consent, participants
will be provided with the Nerivio Migra application (either installed on their own
smartphone, or on a smartphone provided by the study coordinator). The participants will
be trained how to operate the application and report their migraine attacks in the
patient diary mode, which is part of the application. The site personnel will be
required to approve the training session in the CRF.
Stage 1 - Roll in phase The Roll-in is a period of 15 - 30 days in which at least two
(2) and no more of eight (8) migraine attacks has been occurred. During this period,
baseline information including mean frequency and severity of migraine attacks,
occurrence of other headaches, presence of ICHD-3 diagnostic criteria for migraine with
or without aura and use of preventive and rescue medications will be recorded.
2. nd visit Following the Roll-in phase, the participants will arrive to the clinic and
their compliance to the study procedures and eligibility to continue to the next phase
will assessed.
Participants that will be eligible to continue to the treatment phase will undergo the
following:
1. Participant will be randomized into one of the two study group (Active or Sham device)
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, stratified
with by use of preventive medications.
2. Participant will be trained on the device, the application (in diary and treatment
modes), the treatment procedures and the key elements critical for the success of the
study:
- Apply the Nerivio Migra as soon as possible following the onset of the migraine
symptoms and NO LATER than 60 min from onset
- Refrain from taking any rescue medication 2 hours following the start of treatment.
- Perform the treatment for a period of at least 30 minutes (recommended treatment
time is 45 minutes).
Stage 2 - Parallel arms, double- blind treatment phase. 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
migraine. 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 cannot 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 symptoms 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, phonophobia or allodynia, 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 Nerivio
Migra device.
Adverse events will be reported.
Stage 3 (optional, by subject request only) - Open label extended treatment:
Following the completion of double-blind stage of the study, all subjects will be offered a
2-month open label period using the active device.