NCT06029153Completed
Efficacy and Safety of Middle Meningeal Artery Embolization for Treatment of Intractable Migraine
Efficacy and Safety of Middle Meningeal Artery Embolization for Treatment of Intractable Migraine： a Single-arm, Self-control, Open-label, Single-center Trial
Source: ClinicalTrials.gov · Last updated 31 Dec 2024
Brief summary (registry, in English)
This study is a single-arm, self-controlled clinical trial that explores and evaluates the efficacy of middle meningeal artery embolization with coil in improving migraine symptoms. The main objectives of the study are to evaluate the effectiveness and safety of the treatment.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 1 Sept 2023
- Start date
- Jun 2023
- Primary completion date
- Nov 2024
- Lead sponsor
- The Affiliated Hospital Of Guizhou Medical University
- Diseases
- Migraine
- NCT number
- NCT06029153
What you commit to
- Study type: Interventional
- Participants enrolled: 15
- From Jun 2023 to the primary completion date, Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients scheduled for surgery within 90 days.
- Participants who had participated in clinical studies of other drugs or medical devices before enrollment and did not meet the primary study endpoint time limit.
Other illness
- Patients with cervical spondylosis and secondary headaches such as otogenic, nasal, and odontogenic patients with a history of trigeminal autonomic headache, other definite causes of headache, or secondary headache.
- History of contrast agent allergy.
- The patient had a clear history of allergies to embolic materials such as Nitinol alloy, cobalt-based alloy, and platinum-tungsten alloy.
- Patient was allergic to the contrast agent.
- Patients with other diseases limit their participation in the study, cannot follow up, or affect the scientific integrity of the study.
- Patients have clotting disorders or are on anticoagulant therapy.
- Patients have a history of opioid addiction.
Other
- Patients without suitable vascular access.
- The life expectancy of patients is less than 12 months.
- Lactating or pregnant women, or patients with a fertility plan within 1 year.
- The clinical status of the patient was extremely poor, with an mRS Score ≥4.
- The investigator judged that the patient had poor compliance and could not complete the study as required.
- Researchers believe that patients who are not suitable to participate in this trial.
Who the study is looking for
- Voluntary written informed consent.
- Age 18\~80 years old (inclusive), regardless of gender.
- Migraine was diagnosed by clinicians, according to The International Classification of Headache Disorders,3rd Edition
- Patients with intractable migraine or refractory headache with migraine duration of more than 3 months and recurring migraine in the past 90 days before screening.
- Patients who take two or more drugs are not satisfied with the therapeutic effect, the side effects of drug treatment are difficult to tolerate or have contraindications.
- Headache frequency should be confirmed within 30 days before screening.
- Patients with good compliance, willing and able to follow the requirements of treatment and follow-up observation.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Affiliated Hospital of Guizhou Medical University Coordinator of this site? Confirm its status | Guiyang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.