NCT06499116Not yet recruitingPhase 4
Comparison of the Effectiveness of First-line Preventive Treatment of Migraine in Primary Care
Comparison of the Effectiveness of First-line Preventive Treatment of Migraine in Primary Care: a Pragmatic Clinical Trial [PREMI Study]
Source: ClinicalTrials.gov · Last updated 12 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study, which is aimed at comparing the effectiveness of the most frequently used drugs in the first line in primary care for the preventive treatment of migraine (amitriptyline, flunarizine, topiramate and propranolol), is a multicentre, pragmatic, parallel group, open randomised trial. Adults (≥18) candidates for preventive treatment for migraine; those with a frequency of ≥4 monthly migraine days, and who agree to participate in the clinical trial, will be randomised to one of the 4 groups. Sample: 460 patients. The primary outcome will be the reduction in monthly migraine days, comparing amitriptyline, flunarizine and topiramate with propranolol.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 460 (estimated)
- First submitted
- 1 Jul 2024
- Start date
- Oct 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Diseases
- Migraine
- NCT number
- NCT06499116
- EU CT number
- 2024-513597-22-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 460
- From Oct 2024 to the primary completion date, Dec 2026
- 19 sites 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
- 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
Other
- People diagnosed with migraine who are not candidates for preventive migraine treatment
- 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.
Who the study is looking for
- \- Adults (≥18) candidates for preventive treatment for migraine; those with a frequency of ≥4 monthly migraine days, and who agree to participate in the clinical trial.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (19)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CAP La Sagrera Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Sant Martí de Provençals Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| CAP Alhambra Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| CAP Canet de Mar Coordinator of this site? Confirm its status | Canet de Mar | Spain | Recruiting |
| CAP El Castell Coordinator of this site? Confirm its status | Castelldefels | Spain | Recruiting |
| CAP Sant Ildefons Coordinator of this site? Confirm its status | Cornellà de Llobregat | Spain | Recruiting |
| CAP Dr. Martí i Julià Coordinator of this site? Confirm its status | Cornellà de Llobregat | Spain | Recruiting |
| CAP Can Moritz Coordinator of this site? Confirm its status | Cornellà de Llobregat | Spain | Recruiting |
| CAP Cornellà de Llobregat Coordinator of this site? Confirm its status | Cornellà de Llobregat | Spain | Recruiting |
| CAP Santa Clara Coordinator of this site? Confirm its status | Girona | Spain | Recruiting |
| CAP La Florida Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Recruiting |
| CAP Amadeu Torner Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Recruiting |
| CAP Balafia-Pardinyes-Secà de Sant Pere Coordinator of this site? Confirm its status | Lleida | Spain | Recruiting |
| CAP La Granja Coordinator of this site? Confirm its status | Molins de Rei | Spain | Recruiting |
| CAP Palau-Solità i Plegamans Coordinator of this site? Confirm its status | Palau-solità i Plegamans | Spain | Recruiting |
| CAP Horts de Miró Coordinator of this site? Confirm its status | Reus | Spain | Recruiting |
| CAP Santa Coloma de Queralt Coordinator of this site? Confirm its status | Santa Coloma de Queralt | Spain | Recruiting |
| CAP Rambla Coordinator of this site? Confirm its status | Sant Feliu de Llobregat | Spain | Recruiting |
| CAP El Temple - Tortosa Est Coordinator of this site? Confirm its status | Tortosa | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.