Health Condition 1: G431- Migraine with aura Health Condition 2: G430- Migraine without aura
Conditions
Interventions
Intervention1: Nerivioâ?¢: Nerivioâ?¢ is an US FDA-authorized remote electrical
neuromodulation (REN) device for the prophylaxis treatment of migraine with or without aura in patients 12 years old or
Sponsors
Dr. Reddy Laboratories Ltd
Kantar IMRB Contract Research Organization
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects who are aged 12+ years old. 2. Subjects with 4-24 headache days per 28 days in each of previous 3 months preceding study enrolment 3. Patients meeting the ICHD-3 diagnostic criteria for episodic or chronic migraine. 4. Participants either did not use preventive medications, or were on a stable dose of a single migraine preventive medication during the last 2 months before enrollment, and throughout the study period 5. Patients who have personal access to a smartphone 6. Patients who are able and willing to comply with the protocol of the study. 7. Subjects who are able and willing to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Subjects with an implanted electrical and/or neurostimulator device (e.g., cardiac pacemaker, cochlear implant). 2. Subjects with congestive heart failure (CHF), severe cardiac or cerebrovascular disease. 3. Subjects with uncontrolled epilepsy or any other debilitating neuromuscular problems. 4. Subjects who underwent any change in migraine preventive medications (type or dose) in the last two months prior to recruitment and/or during the study 5. Subjects who received OnabotulinumtoxinA/ any botulinum toxin injections, parenteral infusions for migraine within the previous 3 month 6. Subjects who have used opioids/barbiturates on more than 4 days per month in the last 6 months 7. Subjects who are pregnant or trying to get pregnant or subjects who are nursing mothers, at the time of recruitment. Additionally, any female participants who were breastfeeding at least up to six months prior to recruitment 8. Subjects participating in any other interventional clinical study in the past 90 days 9. Subjects without basic cognitive and motor skills needed to operate a smartphone. 10. Subjects who have severe pain with other significant clinical conditions, medical or psychological problems that in the opinion of the investigator may confound the study assessments. 11. Subjects who have been hospitalized at least one month prior to the recruitment or requires hospitalization during the study period. 12. Subjects who have previous experience with Nerivio•. 13. Subjects with known allergy or hypersensitivity reaction to fastening band /or the material of the fastening band of the device. 14. Subjects with any clinical symptom or discomfort or any other problem that in the opinion of the investigator may confound the study assessments or may compromise the safety of the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in number of migraine days per month compared from baseline phase (weeks 1â??4) to the last 9-12 weeks of the treatment phaseTimepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Reduction in mean migraine days (reported Baseline MMDs/28 days Vs MMDs reported between week 9-12) and Reduction in mean migraine days (reported Baseline MMDs/28 days Vs MMDs reported till week 12). 2. Mean change in number of moderate/severe headache days and Mean change in the number of headache days (any severity). 3. Percentage of participants achieving at least 50% reduction from baseline in the mean number of headache days (all severities), and of moderate/severe headache days and measuring behavioral and socio-economic impact. 4. Percentage of patients achieving 50% reduction headache days per month 5.Reduction in the mean number of acute headache/migraine medication days per month compared to Baseline. Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactMr Velangini Reddy
Dr. Reddys Laboratories Ltd.
Outcome results
None listed