Comparison of the Effectiveness of First-line Preventive Treatment of Migraine in Primary Care
NCT ID: NCT06499116
Last Updated: 2024-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE4
460 participants
INTERVENTIONAL
2024-10-31
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of the Effectiveness of Topiramate in Preventing the Transformation From Episodic Migraine to Chronic Daily Headache.
NCT00212810
Comparative Effectiveness of Migraine Preventive Medications: The APT Comparison Study
NCT06972056
The Childhood and Adolescent Migraine Prevention Study
NCT01581281
Prediction of Migraine Prevention Efficacy Based on Individual's Pain Modulation
NCT02101892
Comparing the Safety and Effectiveness of Topiramate With the Safety and Effectiveness of Amitriptyline in Preventing Migraine Headaches
NCT00210821
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Topiramate
25-100 mg/12h, V.O., during 12 weeks
Topiramate
Treatment will be prescribed for GPs and they will decide the specific dosage 25-100 mg/12h.
Flunarizine
2,5-10 mg/24h, V.O., during 12 weeks
Flunarizine
Treatment will be prescribed for GPs and they will decide the specific dosage 2,5-10 mg mg/24h.
Amitriptyline
10-75 mg/24h, V.O., during 12 weeks
Amitriptyline
Treatment will be prescribed for GPs and they will decide the specific dosage 10-75 mg/24h.
Propranolol
20-120 mg/12h, V.O., during 12 weeks
Propranolol
Treatment will be prescribed for GPs and they will decide the specific dosage 20-120 mg/12h.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Topiramate
Treatment will be prescribed for GPs and they will decide the specific dosage 25-100 mg/12h.
Flunarizine
Treatment will be prescribed for GPs and they will decide the specific dosage 2,5-10 mg mg/24h.
Amitriptyline
Treatment will be prescribed for GPs and they will decide the specific dosage 10-75 mg/24h.
Propranolol
Treatment will be prescribed for GPs and they will decide the specific dosage 20-120 mg/12h.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* People diagnosed with chronic migraine (\>15 days of headache per month, of which 8 are monthly migraine days)
* Not having a smartphone
* Simultaneous participation in another clinical trial
* Pregnancy or expected pregnancy during the next 3 months
* Lactation
* People with migraine who already receive preventive treatment.
* People on chronic treatment with opioids or other analgesics or NSAIDs that are not used for the symptomatic treatment of migraine, for example, osteoarthritis.
* People who, in the opinion of the clinician, have an absolute contraindication to one of the study drugs or who cannot perform the trial procedures:
Hypersensitivity to any of the study drugs / Heart block or severe bradycardia / Concomitant treatment with verapamil or diltiazem / Active cardiovascular pathology (recent heart attack, angina, Raynaud's phenomenon) / Major depression or active treatment with antidepressants (including monoamine oxidase inhibitors and St. John's wort) / Other psychiatric illnesses or active treatment with antipsychotics or lithium / Severe liver disease or kidney failure / Parkinson's disease or other extrapyramidal disorders / Epilepsy (diagnosis and/or active treatment) / Any other contraindication that, in the opinion of the clinician, prevents participation in the clinical trial
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Institut Català de la Salut
OTHER
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
OTHER
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Giner-Soriano M, Morros R, Monfa R, Ouchi D, Fernandez-Garcia S, Vedia C, Bonet Monne S, Calvo Martinez EM, Copetti Fanlo S, Morollon N, Belvis Nieto R, Delgado-Espinoza CE, Garcia-Sangenis A. Comparison of the effectiveness of first-line preventive treatment of migraine in primary care: study protocol for a pragmatic clinical trial (PREMI study). Trials. 2025 Aug 26;26(1):311. doi: 10.1186/s13063-025-08961-0.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-513597-22-00
Identifier Type: CTIS
Identifier Source: secondary_id
IJG-PREMI-2024
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.