CTRI/2024/06/069336
Not yet recruiting
Phase 3
Combination Treatment of Greater Occipital Nerve Block and Botulinum Toxin for Resistant Migraine: A Randomized Double-Blind Placebo-Controlled Study (COMBO-GONBOT Study)) - COMBO-GONBOT Study
GB Pant Institute of Postgraduate Medical Education and Research, New Delhi0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- GB Pant Institute of Postgraduate Medical Education and Research, New Delhi
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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