Ignite Creation Date:
2024-05-06 @ 10:51 AM
Last Modification Date:
2024-10-26 @ 12:36 PM
Study NCT ID:
NCT03361423
Status:
COMPLETED
Last Update Posted:
2021-05-19
First Post:
2017-11-18
Brief Title:
Evaluation of a Novel Device for Treatment of Migraine Headache
Sponsor:
Theranica
Organization:
Theranica
Study Overview
Official Title:
A Randomized Double Blinded Sham Controlled Clinical Study to Evaluate the Safety and Efficacy of the Nerivio Migra 1 a Neuromodulation Device for the Acute Treatment of Migraine
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 11 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
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 11 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
Detailed 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 patients 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 11 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 hisher 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
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 patients 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 11 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 hisher 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None