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MigrainePhase 4PREMINCT06499116

Comparison of the Effectiveness of First-line Preventive Treatment of Migraine in Primary Care

A Phase 4 study testing Topiramate, Flunarizine and Amitriptyline in people with Migraine, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Migraine
What is being tested?
Topiramate, Flunarizine and Amitriptyline
Could I receive a placebo?
No, everyone receives an active treatment
How many people
460 participants
Where
No sites listed yet
Study dates
Oct 2024to Dec 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Maria Giner-Soriano contact

+34 93 482 4110

mginer@idiapjgol.info

Ana Garcia-Sangenis contact

+34 93 482 4651

agarcia@idiapjgol.org

About this study

Official title: Comparison of the Effectiveness of First-line Preventive Treatment of Migraine in Primary Care: a Pragmatic Clinical Trial [PREMI Study]

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.

Conditions
Migraine
Being tested
Topiramate, Flunarizine, Amitriptyline, Propranolol
Keywords
Migraine, Monthly Migraine Days (MMD), Preventive treatment, Primary care
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TopiramateDrug

    Also called Acomicil

    Treatment will be prescribed for GPs and they will decide the specific dosage 25-100 mg/12h.

  • FlunarizineDrug

    Also called Sibelium

    Treatment will be prescribed for GPs and they will decide the specific dosage 2,5-10 mg mg/24h.

  • AmitriptylineDrug

    Also called Tryptizol

    Treatment will be prescribed for GPs and they will decide the specific dosage 10-75 mg/24h.

  • PropranololDrug

    Also called Sumial

    Treatment will be prescribed for GPs and they will decide the specific dosage 20-120 mg/12h.

Study groups in NCT06499116
Study groupRoleWhat they receive
TopiramateExperimental25-100 mg/12h, V.O., during 12 weeks
Receives: Drug: Topiramate
FlunarizineExperimental2,5-10 mg/24h, V.O., during 12 weeks
Receives: Drug: Flunarizine
AmitriptylineExperimental10-75 mg/24h, V.O., during 12 weeks
Receives: Drug: Amitriptyline
PropranololActive comparator20-120 mg/12h, V.O., during 12 weeks
Receives: Drug: Propranolol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate the effectiveness of the most frequently used drugs in primary care for the preventive treatment of migraine according to the reduction in monthly migraine days, comparing amitriptyline, flunarizine and topiramate with propranolol.

    Clinical effectiveness: change in the mean number of monthly migraine days (MMD) at 12 weeks of treatment from baseline.

    Measured: 12 weeks

Secondary outcomes (11)

  1. Calculate the rate of responders (reduction of at least 50% in monthly migraine days compared to baseline)

    Proportion of patients responding at 12 weeks from start of treatment; <25% change in mean number of MMD: non-responders, 25-49%: partial responders, 50-75%: responders, >75%: excellent responders.

    Measured: 12 weeks

  2. Evaluate effectiveness before completing the clinical trial

    Change in mean number of MMDs at 4 and 8 weeks from baseline.

    Measured: 4, 8 and 12 weeks

  3. Estimate the reduction in the intensity of migraine attacks

    Reduction in the mean number of moderate-severe MMD at 4, 8 and 12 weeks from the start of treatment.

    Measured: 4, 8 and 12 weeks

  4. Estimate the prevalence of symptoms associated with migraine

    Proportion of patients with associated symptoms at 12 weeks from the start of treatment; photophobia, phonophobia, nausea.

    Measured: 12 weeks

  5. Evaluate adherence to preventive treatment

    Proportion of adherent and non-adherent patients (according to taking [yes/no] of the study treatment with the prescribed dosage) at 12 weeks from the start of treatment.

    Measured: 12 weeks

  6. Estimate the reduction in the use of symptomatic treatment drugs used to treat migraine attacks (analgesics, NSAIDs, triptans, others).

    Change in the mean number of drugs used for symptomatic treatment at 4, 8 and 12 weeks from baseline.

    Measured: 4, 8 and 12 weeks

  7. Evaluate reconsultation visits due to migraine attacks

    Reconsultations: Type of consultation (PCC, PC emergency, hospital, hospital emergency). Number of consultations after 12 weeks from the start. Number of medical tests performed relacionadas con la migraña.

    Measured: 4, 8 and 12 weeks

  8. Evaluate improvement in quality of life and patient satisfaction

    Change in EQ-5D-5L questionnaire at 12 weeks from baseline. Including Visual Analogue Scale (0-100). Lower scores means worse health condition.

    Measured: 12 weeks

  9. Analyze the differences between men and women regarding study drugs effectiveness.

    Result comparison change in mean number of MMDs adjusted by sex

    Measured: 4, 8 and 12 weeks

  10. Estimate the disability associated with migraine attacks according to number of paticipans reporting temporary work disability, absenteeism, presenteeism.

    Change in the number of ILT days, absenteeism, presenteeism at 12 weeks from the start of treatment.

    Measured: 12 weeks

  11. Incidence of adverse events of the four drugs used in the preventive treatment of migraine .

    Number of adverse events

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2024
  2. Study startOct 2024 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
460 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06499116
Sponsor's protocol ID
IJG-PREMI-2024
Other IDs
2024-513597-22-00
Acronym
PREMI
Status last verified
Jul 2024
First submitted
1 Jul 2024
Last updated
12 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: All publications will be free and open access. Publications of clinical trial results are planned in national and/or international scientific journals and in communications to conferences. Results will also be communicated to scientific societies and other actors involved in decision-making in the healthcare field, as well as through dissemination activities to patients and citizens in general.

Publications

  • 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.

    PubMed 40859286

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Topiramate, Flunarizine and Amitriptyline in people with Migraine, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Maria Giner-Soriano (+34 93 482 4110, mginer@idiapjgol.info), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the effectiveness of the most frequently used drugs in primary care for the preventive treatment of migraine according to the reduction in monthly migraine days, comparing amitriptyline, flunarizine and topiramate with propranolol. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06499116, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.

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