Is Greater Occipital Nerve Block Together with Botulinum Toxin Injection a Better Treatment Than Either of These Treatments Alone in Patients with Refractory Migraine

Phase 3

Conditions: Health Condition 1: G431- Migraine with auraHealth Condition 2: G430- Migraine without aura

Registration Number: CTRI/2024/06/069336

Lead Sponsor: GB Pant Institute of Postgraduate Medical Education and Research, New Delhi

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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.