Health Condition 1: G430- Migraine without aura
Conditions
Interventions
Intervention1: Tablet Brivaracetam: There will be three intervention(oral route of administration) groups: Brivaracetam 50mg/day
Brivaracetam 100mg /day and placebo(in two divided doses). patients shall be given treatment according to their group in double blind phase for 12 weeks. it will be followed by open label for another
brivaracetam 100mg /day and placebo(in two divided doses). patients shall be given treatment according to their group in double blind phase. it will be followed by open label where the will be given o
Sponsors
GB Pant Institute of Post Graduate Medical Education and Research, New Delhi 110002
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults 18 to 65 years of age who had have a history of migraine with or without aura (as defined by ICHD-3) for at least 12 months before screening. 2. Patients should be experiencing at least 4 and fewer than 15 migraine headache days during the 4weeks of the baseline phase (as obtained by the paper headache diary). 3. Patients should be experiencing fewer than 15 headache days per month during the last 3 months before baseline the phase (as obtained by history from the patient). 4. Patients must demonstrate at least 80% adherence to reporting with the headache diary during the baseline phase.
Exclusion criteria
Exclusion criteria: 1. Patients older than 50 years at migraine onset. 2. Patients will be excluded if they had no therapeutic response in migraine prevention after an adequate therapeutic trial of >2 of the following medication categories: Category 1: Divalproex sodium, sodium valproate; Category 2: Topiramate; Category 3: Beta blockers; Category 4: Tricyclic antidepressants; Category 5: Serotonin-norepinephrine reuptake inhibitors; Category 6: Flunarizine, verapamil; Category 7: Lisinopril, candesartan. (No therapeutic response will be defined as no reduction in headache frequency, duration, or severity after administration of the medication for =6 weeks at the generally accepted therapeutic dose(s) based on the investigator’s assessment. Lack of sustained response to a medication and failure to tolerate a therapeutic dose will not considered to be “no therapeutic response. ?) 3. The following medications, devices, or procedures will be excluded: Botulinum toxin (in the head and/or neck region) is excluded within 4 months before the start of the baseline phase and throughout the study. 4. Ergotamine derivatives, steroids, and triptans used for migraine prophylaxis are excluded within 3 months before the start of the baseline phase and throughout the study. 5. Devices and procedures used for migraine prophylaxis are excluded within 2 months before the start of the baseline phase and throughout the study. Investigational medications and devices are excluded throughout the study. 6. Patients also must not have used investigational medications or devices for at least 90 days prior to screening. 7. Patients who were concomitantly using medications for migraine prevention within 3 months before the start of the baseline phase and throughout the study will be excluded. 8. Patients with significant suicidal ideation as analysed by Columbia Suicide Severity Rating Scale (C-SSRS) >2 9. Pregnant women, female patients who are not willing for effective contraception. 10. Patient with known allergies against levetiracetam or brivaracetam, patients with history of moderate to severe anxiety or depression, psychosis and chronic liver, kidney and heart diseases shall be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean migraine headache days (MHD) per 28 days compared with baseline at the end of week 12 (migraine day is defined as a calendar day when the patient reported =4 continuous hours of headache meeting ICHD 3 criteria for migraine; additionally, any calendar day on which acute migraine–specific medication (ergot or triptan) is used shall be counted as a migraine day. A qualified migraine headache is defined as a migraine with or without aura, lasting for =30 minutes, and meeting at least one of the following criteria (a and/or b): a) =2 of the following pain features: unilateral, throbbing, moderate to severe, exacerbated with exercise/physical activity and b) =1 of the following associated symptoms: nausea and/or vomiting, photophobia, and phonophobia) Timepoint: 12 week | — |
Secondary
| Measure | Time frame |
|---|---|
| Key Secondary End points 1. Proportions of patients achieving more than 50% reduction in migraine headache days (MHD) per 28 days compared with baseline at the end of week 12 Other Secondary End Points 1. Change in mean number of acute migraine treatment (AMT) days to abort the headache attacks (analgesics/triptans/ergotamines) per 28 days compared with baseline at the end of week 12. 2. Change in mean total duration of migraine headache [cumulative headache hours (CHH)] per 28 days compared with baseline at the end of week 12. 3. Change in mean visual analogue scale (VAS) score per 28 days compared with baseline at the end of week 12. 4. Change in mean HIT-6 (Headache Impact Test) score per 28 days compared with baseline at the end of week 12. 5. Change in mean MIDAS (Migraine Disability Assessment) score per 28 days at the end of week 12. Timepoint: 12 week | — |
Countries
India
Contacts
Public ContactDr Manju Yadav
GB Pant Institute of Post Graduate Medical Education and Research, New Delhi
Outcome results
None listed