Fact CheckerSign in

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

Full criteria on ClinicalTrials.gov

Sites (19)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CAP La Sagrera
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Sant Martí de Provençals
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
CAP Alhambra
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
CAP Canet de Mar
Coordinator of this site? Confirm its status
Canet de MarSpainRecruiting
CAP El Castell
Coordinator of this site? Confirm its status
CastelldefelsSpainRecruiting
CAP Sant Ildefons
Coordinator of this site? Confirm its status
Cornellà de LlobregatSpainRecruiting
CAP Dr. Martí i Julià
Coordinator of this site? Confirm its status
Cornellà de LlobregatSpainRecruiting
CAP Can Moritz
Coordinator of this site? Confirm its status
Cornellà de LlobregatSpainRecruiting
CAP Cornellà de Llobregat
Coordinator of this site? Confirm its status
Cornellà de LlobregatSpainRecruiting
CAP Santa Clara
Coordinator of this site? Confirm its status
GironaSpainRecruiting
CAP La Florida
Coordinator of this site? Confirm its status
L'Hospitalet de LlobregatSpainRecruiting
CAP Amadeu Torner
Coordinator of this site? Confirm its status
L'Hospitalet de LlobregatSpainRecruiting
CAP Balafia-Pardinyes-Secà de Sant Pere
Coordinator of this site? Confirm its status
LleidaSpainRecruiting
CAP La Granja
Coordinator of this site? Confirm its status
Molins de ReiSpainRecruiting
CAP Palau-Solità i Plegamans
Coordinator of this site? Confirm its status
Palau-solità i PlegamansSpainRecruiting
CAP Horts de Miró
Coordinator of this site? Confirm its status
ReusSpainRecruiting
CAP Santa Coloma de Queralt
Coordinator of this site? Confirm its status
Santa Coloma de QueraltSpainRecruiting
CAP Rambla
Coordinator of this site? Confirm its status
Sant Feliu de LlobregatSpainRecruiting
CAP El Temple - Tortosa Est
Coordinator of this site? Confirm its status
TortosaSpainRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.