BridgeMD
Tests treatment safety and results for Episodic Migraine
Official title Efficacy of Gou-Teng-San (GTS) in Patients With Episodic Migraine
ClinicalTrials.gov ID: NCT07496034
What this study is testing
What is Gou-Teng-San?
Gou-Teng-San is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for episodic migraine.
Also referred to as Gou-Teng-San and standard care.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this study is to learn whether Gou-Teng-San (GTS), a traditional herbal medicine, is effective and safe for adults with episodic migraine. In this double-blind randomized controlled trial, participants with episodic migraine will be assigned by chance to a study treatment group.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Adults aged 18 to 70 years.
- History of episodic migraine for at least 12 months before screening, meeting the International Classification of Headache Disorders, 3rd edition...
- During the 28-day screening period, participants must meet criteria for episodic migraine, defined as headache occurring on \>=6 and \ =4 days meet...
- Not receiving preventive migraine medication for at least 5 half-lives before enrollment, or receiving no more than 1 preventive migraine medication...
- Body mass index (BMI) between 17.5 and 37.5 kg/m2, and body weight between 35 and 120 kg.
You likely can't join if
- Known allergy or hypersensitivity to Gou-Teng-San or any of its ingredients.
- Receipt of botulinum toxin type A injections in the head, face, or neck for any reason within 4 months before screening.
- Use of opioid-containing or barbiturate-containing medications on more than 4 days per month.
- Lack of how well it works after at least 3 months of treatment at accepted migraine treatment doses in 2 or more of the following preventive...
- Use of migraine treatment interventions within 2 months before screening, such as nerve block or transcranial magnetic stimulation.
- Clinically significant hematologic, cardiac, renal, endocrine, pulmonary, gastrointestinal, urinary, neurologic, hepatic, ophthalmologic...
See the full eligibility criteria
- Adults aged 18 to 70 years.
- History of episodic migraine for at least 12 months before screening, meeting the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria, or clinically diagnosed migraine with no more...
- During the 28-day screening period, participants must meet criteria for episodic migraine, defined as headache occurring on \>=6 and \ =4 days meet at least 1 of the following: (1) ICHD-3 criteria C and D for 1.1...
- Not receiving preventive migraine medication for at least 5 half-lives before enrollment, or receiving no more than 1 preventive migraine medication at a stable dose and regimen for at least 2 months before informed...
- Body mass index (BMI) between 17.5 and 37.5 kg/m2, and body weight between 35 and 120 kg.
- Adequate compliance with headache diary completion during screening, defined as completion on at least 24 of 28 days (\>=85%), with diary data considered acceptable by the investigator.
- Able to comply with study restrictions and complete all protocol-required study procedures.
- Able to understand and sign the informed consent form.
- No major cardiovascular, hepatic, or renal disease.
- Known allergy or hypersensitivity to Gou-Teng-San or any of its ingredients.
- Receipt of botulinum toxin type A injections in the head, face, or neck for any reason within 4 months before screening.
- Use of opioid-containing or barbiturate-containing medications on more than 4 days per month.
- Lack of how well it works after at least 3 months of treatment at accepted migraine treatment doses in 2 or more of the following preventive medication classes: (1) topiramate or valproic acid; (2) flunarizine; (3)...
- Use of migraine treatment interventions within 2 months before screening, such as nerve block or transcranial magnetic stimulation.
- Clinically significant hematologic, cardiac, renal, endocrine, pulmonary, gastrointestinal, urinary, neurologic, hepatic, ophthalmologic, psychiatric, or other disease that, in the investigator's judgment, would...
- Participation in another clinical trial of a drug or medical device within 2 months before screening, or within 5 half-lives of the investigational product used in that trial, whichever is longer.
- Use of other Chinese herbal medicines within 4 weeks before screening.
- Previous exposure to monoclonal antibodies targeting the calcitonin gene-related peptide (CGRP) pathway or CGRP receptor antagonists.
- History of alcohol or drug abuse within the past 2 years.
- Women who are breastfeeding, have a positive pregnancy test at screening, or are unwilling to use contraception during the study if of childbearing potential.
- Any other condition or circumstance that, in the investigator's judgment, would make the participant unsuitable for the study or unlikely to complete the study successfully.
The study team makes the final eligibility decision.
Where it's taking place
- Taichung, South, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taichung, South, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.