Phase 3 Migraine Trial, Recruiting

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

Who might be able to join this trial:

• Adults between 18 and 65 years of age (inclusive)
• People who have been formally diagnosed with migraine (with or without aura) for at least 1 year, according to recognised international headache diagnostic standards
• People whose first migraine occurred before the age of 50
• People who have had between 4 and fewer than 15 migraine days per month, on average, over the 3 months before the screening period
• People who have had fewer than 15 total headache days per month (including all headache types) over the 3 months before the screening period
• People who are willing to use effective contraception during the trial and for 28 days after the last dose of the study treatment
• People who are willing to follow the study procedures, participate voluntarily, and sign a written consent form

The following criteria also apply during the baseline (observation) period before random assignment to a treatment group:

• People who experience between 4 and fewer than 14 migraine days within the 4-week baseline period, as recorded in an electronic headache diary
• People who have fewer than 14 total headache days within the 4-week baseline period
• People who complete at least 80% of the electronic headache diary entries during the 4-week baseline period (at least 23 out of 28 days), and whom the trial investigator believes can read, understand, and complete the required questionnaires
• People who sign a second written consent form agreeing to continue into the randomised, double-blind, placebo-controlled treatment phase

Who may not be able to join:

• People diagnosed only with "possible migraine" (rather than confirmed migraine) under the relevant international diagnostic criteria
• People who have been diagnosed with any other primary or secondary headache condition, or painful nerve condition affecting the head, other than migraine
• People for whom more than two categories of standard migraine prevention medicines have been tried adequately and found to be ineffective — this includes specific groups of medicines such as certain anti-seizure drugs, beta-blockers, certain antidepressants, certain blood pressure medicines, and medicines that work on the CGRP pathway (confirm specific categories with the trial site)
• People who have used certain prohibited medicines, traditional medicines, herbal remedies, medical devices, or specific therapies in the 2 months before or during the baseline period (confirm the full list with the trial site)
• People who have received, or plan to receive, injections of botulinum toxin (such as Botox) into the head, face, or neck for medical or cosmetic reasons within 4 months before screening or during the study
• People who have been using two or more medicines intended to prevent migraines in the 2 months before the baseline period, or during the baseline period; if only one preventive medicine is used, the dose must have been stable for at least 2 months before the baseline period and must remain stable throughout the study
• People who, in the 2 months before the baseline period, were regularly using certain pain-relief medicines too frequently — for example, taking triptans or ergotamine-type medicines 10 or more days per month, taking anti-inflammatory painkillers (NSAIDs) 15 or more days per month (or combination NSAID products 10 or more days per month), or taking opioid or barbiturate pain medicines 4 or more days per month
• People currently taking certain specific medicines that may interact with the study drug, including a number of antibiotics, heart rhythm medicines, stomach medicines, antiviral medicines, blood pressure medicines, and others (confirm the full list with the trial site)
• People who have an ongoing chronic pain condition other than migraine, such as fibromyalgia or chronic pelvic or facial pain
• People with a history of serious mental illness such as schizophrenia or bipolar disorder, or people who score 15 or above on a standard depression questionnaire (PHQ-9); people with a history of anxiety or depression may be considered if their depression score is below 15 and they are taking no more than one mental health medicine at a stable dose for at least 3 months before the baseline period (confirm with trial site)
• People with a serious neurological condition other than migraine (a single childhood febrile seizure is not considered a reason for exclusion)
• People who have had a diagnosis of cancer within the 5 years before the screening period — certain skin cancers and early-stage breast or cervical conditions may be exceptions (confirm with trial site)
• People whose blood test results during screening show liver enzyme levels, bilirubin levels, or kidney function outside acceptable ranges as defined by the trial (confirm specific values with the trial site)
• People with a history of heart disease, heart failure, abnormally slow heart rate, low blood pressure (including when standing), stroke, or a mini-stroke (transient ischaemic attack)
• People whom the trial investigator considers to be at significant risk or unsuitable for participation for any medical or other reason
• People who, based on a clinical interview or a standard risk assessment questionnaire, are considered by the investigator to be at risk of harming themselves or others
• People with a history of drug or alcohol misuse in the 12 months before the screening period, based on medical records or self-report
• People who are pregnant, breastfeeding, or planning to become pregnant during the study, or who have a positive pregnancy test at screening
• Women of childbearing potential who are unwilling to use an acceptable and effective method of contraception during the study (women who are post-menopausal or have had certain surgical procedures may be considered exempt — confirm with trial site)
• People who have participated in another clinical trial within 3 months before the screening period
• People who are known to be allergic to tizanidine hydrochloride or any of its ingredients
• People who are unable to maintain their usual diet and lifestyle habits during the trial
• People who plan to take oestrogen and/or progesterone medicines during or after the screening period
• People who are researchers working on this study, or their immediate family members (such as a parent, spouse, sibling, or child)

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