Health Condition 1: G431- Migraine with aura Health Condition 2: G430- Migraine without aura
Conditions
Interventions
Intervention1: GONB (Greater Occipital Nerve Block) and BoT-A (Botulinum Toxin): GONB with 2% lidocaine(2ml) every 4 weeks and BoT-A (5U, 0.1ml) at 31 sites
as per PREEEMPT design) every 12 weeks
GONB
syringe 2: 40 units (0.8ml) for temporalis muscles
syringe 3: 50 units (1ml) for paraspinal and occipital muscles and syringe 4: 30 units ( 0.6ml) for trapezius muscles.
All patients will be administered GON block initially followed 1 hour later by Bo
Sponsors
GB Pant Institute of Postgraduate Medical Education and Research, New Delhi
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)12 for at least 12 months before screening and fulfils the European Headache Federation (EHF) consensus criteria for resistant migraine. 2. Patients should be experiencing =8 days/month of disabling headache for at least 3 months (as defined by EHF criteria). 3. Patients with failure to three treatment classes of drugs (with established evidence for migraine prevention) given at an appropriate dose for an appropriate duration (as defined by EHF consensus criteria). 4. Patients with medication overuse [overuse of triptans, ergot derivatives, analgesics, and combination drugs (any combination of those above or simple analgesics with opiates or butalbital)] will be permitted to participate in this study.
Exclusion criteria
Exclusion criteria: 1. Patients older than 50 years at migraine onset 2. Patients who have previously received and failed BoT-A and GONB treatments during the last 6 months or less prior to the inclusion. 3. Patients who had previously received anti-CGRP-mAbs three months or less before their enrolment. 4. Patients who had received neuromodulation devices and undergone procedures such as multiple nerve blocks used for migraine prophylaxis. 5. Patients who had received investigational medications and devices for migraine prevention. 6. All patients with a clinical phenotype of episodic or chronic migraine but on further investigation, found to have a secondary cause for their headaches will be excluded. 7. Pregnant women, patients with known allergies against lidocaine or BoT-A, patients with history of moderate to severe anxiety or depression, psychosis and chronic liver, kidney and heart diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean disabling headache days per 28 days compared with baseline at the end of week 24Timepoint: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical global impression improvement (CGI-I) score per 28 days at the end of week 24Timepoint: 24 weeks;Proportions of patients achieving more than 50% reduction in disabling headache days per 28 days compared with baseline at the end of week 24Timepoint: 24 weeks;Proportions of patients in each group having treatment emergent adverse events including serious adverse events at the end of week 24Timepoint: 24 weeks;Change in clinical global impression severity (CGI-S) score per 28 days compared with baseline at the end of week 24Timepoint: 24 weeks;Change in mean HIT-6 (Headache Impact Test) score per 28 days compared with baseline at the end of week 24Timepoint: 24 weeks;Change in mean MIDAS (Migraine Disability Assessment) score per 28 days at the end of week 24Timepoint: 24 weeks;Change in mean migraine days per 28 days compared with baseline at the end of week 24. (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: 24 weeks;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 24Timepoint: 24 weeks;Change in mean Numerical Pain Rating Scale per 28 days compared with baseline at the end of week 24Timepoint: 24 weeks;Change in mean total duration of disabling headache [cumulative headache hours (CHH)] per 28 days compared w | — |
Countries
India
Contacts
Public ContactDr Mahak Golani
GB Pant Institute of Postgraduate Medical Education and Research, New Delhi
Outcome results
None listed