Health Condition 1: G437- Chronic migraine without aura Health Condition 2: G431- Migraine with aura Health Condition 3: G430- Migraine without aura
Conditions
Interventions
Intervention1: Nerivio: The Nerivio™ device is a wireless wearable battery-operated stimulation unit controlled by a smartphone software application. Nerivio is intended for the acute and preventive t
Sponsors
Dr Reddys Laboratories Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 12-75 years old 2. Meeting the ICHD-3 diagnostic criteria for migraine with or without aura. 3. Participants must be on a stable dose of a single migraine preventive medication during the 2 months before enrollment. 4. Must be able and willing to comply with the protocol. 5. Must be able and willing to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Use of antipsychotics on a regular basis during the 3 months prior to consideration for enrolment. 2. Having implanted electrical and/or neurostimulator device (e.g. cardiac pacemaker or defibrillator, vagus nerve neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator cochlear implant, Sphenopalatine ganglion stimulator or Occipital nervestimulator). 3. Participants with congestive heart failure (CHF), severe cardiac or cerebrovascular disease. 4. Known uncontrolled epilepsy. 5. Any use of Cannabis, including medical use. 6. Has undergone nerve block (occipital or other) in the head or neck within the last 2 weeks. 7. Change in oral migraine preventive medications (type or dose) in the last two months prior to recruitment and/or during the study. 8. Subject is participating in any other clinical study. 9. Not having the basic cognitive and motor skills needed tooperate a smartphone. 10. Pregnant, or trying to get pregnant or breastfeeding female participants. Details regarding UPT (Urine Pregnancy Test) results must be documented. 11. Participants with other significant pain, medical or psychological problems that in the opinion of the investigator may confound the study assessments. 12. Subject is experiencing a menstrually-related migraine. 13. Received OnabotulinumtoxinA/any botulinum toxin injections, parenteral infusions for migraine within the previous 3 month. 14. Subject participated in a previous study with the Nerivio device. 15. Subject with arm circumference below 7.9 inches (20 cm). Note - Females of childbearing potential must have a negative pregnancy test and must be willing to use adequate contraception during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of migraine pain at 2 hours: Proportion (%) of subjects reporting reduction in their pain level 2 hours post-treatment without rescue medications from severe or moderate to mild or no pain, or from mild to no pain, in their second treated migraine attack (excluding the first treatment).Timepoint: 2 hours post treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain and MBS relief at 2 hours: Proportion (%) of subjects reporting post-treatment response to both the primary and the first secondary endpoints at 2 hours post- treatment.Timepoint: 2 hours post treatment;Pain-free at 2 hours: Proportion (%) of subjects reporting freedom from migraine pain at 2 hours post-treatment without rescue medications in their second treated migraine attack. Pain-free is defined as improvement from mild, moderate, or severe pain to none.Timepoint: 2 hours post-treatment;Freedom from most bothersome migraine-associated symptom (MBS) at 2 hours: Proportion (%) of subjects reporting, 2 hours post-treatment, freedom from their MBS other than a headache, in their second treated migraine attack. MBS may be nausea, or vomiting or photophobia, or phonophobia or combination of them -as defined by each subject at the beginning of the treatment.Timepoint: 2 hours post treatment;Rescue medications use within 2 hours: Proportion (%) of subjects reporting use of rescue/acute medication within 2 hours post-treatment in their second treated migraine attack.Timepoint: 2 hours post-treatment;Sustained MBS freedom at 24 hours: Proportion (%) of subjects reporting post-treatment response to the first secondary endpoints at 24 hours.Timepoint: 24 hours post treatment;Sustained pain and MBS Relief at 24 hours: Proportion (%) of subjects reporting post-treatment response to both the primary and the first secondary endpoints at 24 hours.Timepoint: 24 hours post treatment;Sustained pain-free at 24 hours with a single use of the device: Proportion (%) of subjects reporting pain-free at 2 hours, and no return of any pain or use of rescue/acute medication, or reuse of device between 2 hours and 24 hours, in their second treated migraine attack.Timepoint: 2-24 hours post treatment;Rescue medications use between 2-24 hours: Proportion (%) of subjects reporting use of rescue/acute medication between 2- and 24-hours post-treatment in their second treated migraine | — |
Countries
India
Contacts
Public ContactDr Punit Srivastava
Dr. Reddy’s Laboratories Limited
Outcome results
None listed