Health Condition 1: G437- Chronic migraine without aura
Conditions
Interventions
Intervention1: Greater occipital nerve block
using methylprednisolone and
lignocaine
: The site of injection shall be marked i.e. approximately two thirds of the distance on a line drawn from the cent
Sponsors
GB Pant Institute of Post Graduate Medical Education and Research
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 =15 days/month of headache for more than 3 months, having features of migraine headache on at least 8 days/month (as obtained by history from the patient). 3.Patients should be experiencing headache =15 days/4 weeks, having features of migraine headache on at least 8 days/4 weeks during the baseline the phase (as recorded by headache diary) 4.Patients must demonstrate at least 80% adherence to reporting with the headache diary during the baseline phase. 5.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 will be excluded if they had no therapeutic response in migraine prevention after an adequate therapeutic trial of =3 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; 8 Botulinum toxin; 9 GONB. (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.Patients who received 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.Devices and procedures such as GONB used for migraine prophylaxis are excluded within 4 months before the start of the baseline phase and throughout the study. 5.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 baseline phase. 7.All patients with a clinical phenotype of chronic migraine but on further investigation, found to have a secondary cause for their headaches will be excluded. 8.Pregnant women, patient with known allergies against lidocaine or methylprednisolone, 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 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in clinical global impression severity (CGI-S) score per 28 days compared with baseline at the end of week 12Timepoint: 12 weeks;Change in mean headache days per 28 days compared with baseline at the end of week 12Timepoint: 12 weeks;Change in mean HIT-6 (Headache Impact Test) score per 28 days compared with baseline at the end of week 12Timepoint: 12 weeks;Change in mean MIDAS (Migraine Disability Assessment) score per 28 days at the end of week 12Timepoint: 12 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 12Timepoint: 12 weeks;Change in mean total duration of migraine headache [cumulative headache hours (CHH)] per 28 days compared with baseline at the end of week 12Timepoint: 12 weeks;Change in mean visual analogue scale (VAS) score per 28 days compared with baseline at the end of week 12Timepoint: 12 weeks;Change in migraine specific quality of life score per 28 days compared with baseline at the end of week 12Timepoint: 12 weeks;Clinical global impression improvement (CGI-I) score per 28 days at the end of week 12Timepoint: 12 weeks;Proportions of patients achieving more than 50% reduction in migraine headache days (MHD) per 28 days compared with baseline at the end of week 12Timepoint: 12 weeks;Proportions of patients in each group having treatment emergent adverse events including serious adverse events at the end of week 12Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactDr Arijit Pal
Department of Neurology, GB Pant Institute of Post Graduate Medical Education and Research
Outcome results
None listed