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:

• You are between 18 and 70 years old.
• You have had migraines on and off (not constant) for at least 12 months before the screening period, diagnosed according to standard medical guidelines or by a doctor.
• During the 28-day screening period, you experienced headaches on at least 6 but no more than 14 days, with at least 4 of those days being migraine days (confirmed through a headache diary).
• You are either not currently taking any medication to prevent migraines, or you are taking no more than one such medication at a steady dose for at least 2 months before joining.
• Your body weight is between 35 kg (about 77 lbs) and 120 kg (about 265 lbs), and your body mass index (a measure of weight relative to height) is between 17.5 and 37.5.
• You completed a headache diary on at least 24 out of 28 days during the screening period.
• You are able to follow the study rules and complete all required steps in the trial.
• You are able to understand and sign the consent form agreeing to participate.
• You do not have any serious heart, liver, or kidney disease.

Who may not be able to join:

• You have a known allergy or sensitivity to Gou-Teng-San (the herbal medicine being studied) or any of its ingredients.
• You received Botox (botulinum toxin type A) injections in your head, face, or neck for any reason within the past 4 months.
• You use medications containing opioids or barbiturates (certain types of strong painkillers or sedatives) on more than 4 days per month.
• You have already tried at least 2 types of standard migraine prevention medications for 3 or more months each without success (confirm with trial site).
• You had a procedure such as a nerve block or transcranial magnetic stimulation (a brain stimulation treatment) to treat migraines within the past 2 months.
• You have a significant ongoing medical condition — such as a serious heart, lung, kidney, liver, neurological, or psychiatric problem — that the doctor running the trial believes could interfere with your participation.
• You have taken part in another clinical trial of a drug or medical device within the past 2 months, or within a certain time period related to that trial's medication (whichever is longer).
• You have used any other Chinese herbal medicines within the past 4 weeks.
• You have previously been treated with a specific class of newer migraine medications known as CGRP-targeting therapies (confirm with trial site).
• You have had a problem with alcohol or drug misuse within the past 2 years.
• You are currently breastfeeding, are pregnant, or are unwilling to use contraception during the study if you are able to become pregnant.
• The doctor running the trial has another reason to believe you would not be a good fit or would be unlikely to complete the study.

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