RCT of Non-Invasive Vagus Nerve Stimulation (nVNS) With gammaCore®, for the Acute Treatment of Migraine Attacks
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|ClinicalTrials.gov Identifier: NCT02686034|
Recruitment Status : Recruiting
First Posted : February 19, 2016
Last Update Posted : November 28, 2016
|Condition or disease||Intervention/treatment||Phase|
|Migraine||Device: gammaCore-S Device: gammaCore-S Sham||Not Applicable|
Period 1: 4-week observational run-in period; no stimulation treatment. Subjects use standard of care (SoC) medication to treat their migraine attacks, according to their individual prescriptions.
Period 2: 4-week randomized/controlled period. After the run-in period, subjects are randomized (1:1) to receive either an nVNS device or a sham device to treat up to 5 migraine attacks.
Period 3: 4-week open-label (active treatment) period. After the randomized period, subjects continue to the open-label period where all subjects receive an active gammaCore device to treat up to 5 migraine attacks.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Prospective, Multi-centre, Randomized, Double-blind, Sham-controlled Study of gammaCore® Non-invasive Vagus Nerve Stimulator (nVNS), for the Acute Treatment of Migraine|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||April 2017|
Active Comparator: gammaCore-S
Treatment of up to 5 migraine attacks with the Active gammaCore-S non-invasive vagus nerve stimulator device which delivers a mild electrical signal in the vicinity of the vagus nerve
At onset of migraine pain, the subject self-administers a bilateral treatment with the gammaCore nVNS device (2 minutes on the right side, and 2 minutes on the left side). If their headache pain has not improved after 15 minutes, they administer another bilateral treatment. If they are not pain-free at 2 hours, they have the option to administer a third bilateral treatment, or take their usual rescue medication.
Other Name: nVNS
Sham Comparator: gammaCore-S Sham
Treatment of up to 5 migraine attacks with the Sham gammaCore-S non-invasive vagus nerve stimulator device which delivers a mild electrical signal in the vicinity of the vagus nerve
Device: gammaCore-S Sham
At onset of migraine pain, the subject self-administers a bilateral treatment with the gammaCore nVNS Sham device (2 minutes on the right side, and 2 minutes on the left side). If their headache pain has not improved after 15 minutes, they administer another bilateral treatment with the Sham device. If they are not pain-free at 2 hours, they have the option to administer a third bilateral treatment with the Sham device, or take their usual rescue medication.
Other Name: sham nVNS
- Treatment Response - No Pain [ Time Frame: 2 hours post-treatment ]The primary objective is to compare the treatment response for nVNS and Sham therapies at two hours post-treatment, for the first treated migraine attack during study Period 2. Treatment response is defined as no pain at 2 hours post-treatment.
- Nausea/Vomiting [ Time Frame: 2 hours post-treatment ]• Presence or absence of nausea/vomiting, photophobia and phonophobia (baseline pre-treatment vs 2-hours post-treatment) for nVNS and sham therapies for the first migraine attack treated during study Period 2.
- Treatment Response - No Pain or Mild Pain [ Time Frame: 2 hours post-treatment ]• Response of no pain or mild pain on the 4-point headache pain scale for the nVNS and sham therapies at 2 hours post-treatment for the first migraine attack treated during study Period 2.
- Sustained Treatment Response [ Time Frame: 24 and 48 hours post-treatment ]• Sustained treatment response at 24 and 48 hours post-treatment for nVNS and sham therapies for the first attack treated during study Period 2. Sustained treatment response is defined as achievement of treatment response and no subsequent increase on the 4 point headache pain scale. A new migraine attack is defined as an attack starting more than 48 hours after relief of the prior migraine attack.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02686034
|Contact: Cristina Tassorelli, MD, PhD||+39 333 171 firstname.lastname@example.org|
|University Aldo Moro, Ospedale Pediatrico||Not yet recruiting|
|Contact: Marina De Tommaso, MD, PhD|
|IRCCS Istituto delle Scienze Neurologiche di Bologna, Ospedale Bellaria||Recruiting|
|Contact: Pietro Cortelli, MD, PhD|
|University Hospital of Careggi||Not yet recruiting|
|Contact: Pierangelo Geppetti, MD, PhD|
|Fondazione IRCCS Istituto Neurologico C. Besta||Recruiting|
|Contact: Licia Grazzi, MD|
|IRCSS "National Neurological Institute C. Mondino" Foundation||Recruiting|
|Contact: Cristina Tassorelli, MD, PhD|
|S. Maria della Misericordia Hospital||Recruiting|
|Contact: Paola Sarchielli, MD, PhD|
|INM Neuromed IRCCS||Recruiting|
|Contact: Anna Ambrosini, MD, PhD|
|IRCCS San Raffaele Pisana||Recruiting|
|Contact: Piero Barbanti, MD, PhD|
|Sant'Andrea Hospital, Sapienza University of Rome||Not yet recruiting|
|Contact: Paolo Martelletti, MD, PhD|
|University of Turin||Not yet recruiting|
|Contact: Innocenzo Rainero, MD, PhD|
|Study Chair:||Cristina Tassorelli, MD, PhD||IRCSS "National Neurological Institute C. Mondino" Foundation|