Gou-Teng-San (GTS) for adults with episodic migraine

"Efficacy of Gou-Teng-San (GTS) in Patients With Episodic Migraine: A Double-Blind Randomized Controlled Trial" (GTSEM Trial)

This trial will test whether the herbal formula Gou-Teng-San (GTS) can reduce migraine attacks and symptoms in adults with episodic migraine.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: China Medical University, Taiwan (other)
• Locations: 1 site (Taichung, South)
• Trial ID: NCT07496034 on ClinicalTrials.gov

What this trial studies

This is a double-blind, randomized, placebo-controlled Phase 3 trial comparing oral Gou-Teng-San (GTS) to matched placebo in adults aged 18–70 with episodic migraine. Participants are randomized to receive GTS or placebo and will be followed to measure changes in migraine frequency, migraine-related symptoms, and the impact of migraine on daily life. Eligibility requires a 28-day screening diary showing 6–14 headache days with at least 4 qualifying migraine days, and limited or stable use of preventive migraine medications. Safety and tolerability are monitored throughout the trial.

Who should consider this trial

Good fit: Adults aged 18 to 70 with a history of episodic migraine (meeting ICHD-3 criteria or clinician diagnosis) who document 6–14 headache days with at least 4 migraine days during a 28-day screening period are the intended candidates.

Not a fit: People with chronic migraine (more than 14 headache days per month), those outside the 18–70 age range, or those on multiple unstable preventive migraine medications may not benefit from this trial's intervention.

Why it matters

Potential benefit: If successful, GTS could offer an additional herbal treatment option that reduces the number and severity of migraine attacks for some patients.

How similar studies have performed: Use of GTS for migraine is relatively novel and larger randomized evidence is limited, so similar approaches have had mixed or insufficient proof of benefit to date.

Eligibility criteria

Inclusion 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 appropriate ICHD-3 diagnosis.
* During the 28-day screening period, participants must meet criteria for episodic migraine, defined as headache occurring on \>=6 and \<=14 days, of which \>=4 days meet at least 1 of the following: (1) ICHD-3 criteria C and D for 1.1 migraine without aura; (2) ICHD-3 criteria B and C for 1.2 migraine with aura; (3) probable migraine (missing 1 migraine criterion); or (4) headache considered to be migraine based on a positive response to migraine-specific acute treatment (e.g., a triptan or an ergotamine derivative).
* 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 consent, whether for migraine or another medical condition (e.g., propranolol for hypertension).
* 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.

Exclusion Criteria:

* 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 efficacy 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) amitriptyline, venlafaxine, or duloxetine; (4) atenolol or propranolol.
* 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 interfere with study participation or study procedures.
* 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.

Where this trial is running

Taichung, South

• Chung Shan Medical University Hospital — Taichung, South, Taiwan (RECRUITING)

Study contacts

• Study coordinator: Chueh-Yi Tsai, MD, MS

Conditions: Episodic Migraine, Episodic migraine, Gou-Teng-San, Gou Teng San, Choto-san