Phase 2 Migraine Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are able to give written consent and agree to follow the study's requirements
• People aged 18 to 80 years old at the time of signing the consent form
• People who have been diagnosed with either episodic migraine (EM) or chronic migraine (CM), according to recognised medical guidelines, for at least 12 months before the screening visit
• People who were first diagnosed with migraine at age 50 or younger
• People in the episodic migraine group: those who had no more than 14 headache days (migraine or non-migraine) and at least 6 migraine days in the 4 weeks before the study start date, as recorded in an electronic diary
• People in the chronic migraine group: those who had 15 or more headache days and at least 8 migraine days in the 4 weeks before the study start date, as recorded in an electronic diary
• People who have previously tried at least one preventive (preventative) treatment for migraine

Who may not be able to join:

• People who have been diagnosed with certain specific types of headache or migraine, including migraine with brainstem aura, retinal migraine, tension-type headache, cluster headache or related conditions, hypnic headache, hemicrania continua, or new daily persistent headache
• People whose headaches are caused by another medical condition (except headaches caused by overusing pain medication)
• People with a current mental health or psychological condition that is not well controlled, or that could affect the study assessments or their ability to participate
• People who are considered to be at risk of harming themselves or others, based on past behaviour or responses to a specific safety questionnaire at screening or on Day 1
• People with significant swallowing difficulties — specifically those rated as severe on a recognised swallowing scale — that could be made worse by botulinum toxin treatment
• People with a skin condition or active skin infection at or near the injection sites that could interfere with receiving the study treatment
• People with any other medical condition or situation that a doctor considers would make study participation unsuitable
• People who are already taking more than one allowable preventive migraine treatment at the same time
• People who have previously tried more than 4 preventive migraine medications without adequate benefit (including at least 2 that work differently from botulinum toxin)
• People who have used botulinum toxin for migraine within the past 24 weeks, or for any other reason within the past 16 weeks
• People who have used certain migraine-prevention injections (monoclonal antibodies targeting the CGRP pathway) within the past 12 weeks
• People who have used certain oral CGRP-blocking medications (gepants) for migraine prevention within the past 2 weeks
• People who have had an anaesthetic or steroid injection in a treatment area within the past 4 weeks
• People who have used cannabis-based products (including cannabidiol/CBD) within the past 30 days
• People who have used a medical device to treat migraine (such as nerve stimulation or magnetic stimulation devices) within the past 4 weeks
• People who have used certain other migraine treatments — such as acupuncture in the head or neck, occipital nerve blocks, or dental splints for headache — within the past 4 weeks
• People who have used opioid or barbiturate medications on more than 2 days per month in the past 4 weeks
• People currently taking part in another interventional clinical study, or who have done so within a timeframe set by local regulations
• People with other significant ongoing pain conditions — such as fibromyalgia, chronic back pain, or complex regional pain syndrome — that could affect headache assessments or study participation
• Women who are pregnant, breastfeeding, or who could become pregnant and are unwilling to use an acceptable form of contraception from the start of the study and for at least 12 weeks after receiving the study treatment
• Men who have not had a vasectomy and whose female partners could become pregnant, if they are unwilling to use condoms with spermicide for at least 12 weeks after the first dose of study treatment
• People with a history of alcohol or drug misuse within the 5 years before the screening visit (not including overuse of headache medications)
• People with a body mass index (BMI) of 35 or above at the time of screening
• People with a known significant allergic reaction to any ingredient in the study drug or the materials used to give it
• People considered by their doctor to be actively at risk of suicide
• People with a diagnosed neuromuscular or respiratory condition — such as myasthenia gravis, Lambert-Eaton syndrome, or ALS — that a doctor considers would affect their safety in the study

Important: Always verify eligibility with the trial site directly before applying.