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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-513597-22-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Institut CatalĆ de la Salut | OTHER |
| FundaciĆ³ Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | OTHER |
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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 (ā„18) candidates for preventive treatment for migraine; those with a frequency of ā„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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topiramate | Experimental | 25-100 mg/12h, V.O., during 12 weeks |
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| Flunarizine | Experimental | 2,5-10 mg/24h, V.O., during 12 weeks |
|
| Amitriptyline | Experimental | 10-75 mg/24h, V.O., during 12 weeks |
|
| Propranolol | Active Comparator | 20-120 mg/12h, V.O., during 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topiramate | Drug | Treatment will be prescribed for GPs and they will decide the specific dosage 25-100 mg/12h. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
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Inclusion Criteria:
- Adults (ā„18) candidates for preventive treatment for migraine; those with a frequency of ā„4 monthly migraine days, and who agree to participate in the clinical trial.
Exclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Giner-Soriano | Contact | +34 93 482 4110 | mginer@idiapjgol.info | |
| Ana Garcia-Sangenis | Contact | +34 93 482 4651 | agarcia@idiapjgol.org |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40859286 | Derived | 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. |
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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.
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077236 | Topiramate |
| D005444 | Flunarizine |
| D000639 | Amitriptyline |
| D011433 | Propranolol |
| ID | Term |
|---|---|
| D005632 | Fructose |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 |
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| Flunarizine | Drug | Treatment will be prescribed for GPs and they will decide the specific dosage 2,5-10 mg mg/24h. |
|
|
| Amitriptyline | Drug | Treatment will be prescribed for GPs and they will decide the specific dosage 10-75 mg/24h. |
|
|
| Propranolol | Drug | Treatment will be prescribed for GPs and they will decide the specific dosage 20-120 mg/12h. |
|
|
| Evaluate effectiveness before completing the clinical trial |
Change in mean number of MMDs at 4 and 8 weeks from baseline. |
| 4, 8 and 12 weeks |
| 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. | 4, 8 and 12 weeks |
| 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. | 12 weeks |
| 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. | 12 weeks |
| 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. | 4, 8 and 12 weeks |
| 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 migraƱa. | 4, 8 and 12 weeks |
| 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. | 12 weeks |
| Analyze the differences between men and women regarding study drugs effectiveness. | Result comparison change in mean number of MMDs adjusted by sex | 4, 8 and 12 weeks |
| 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. | 12 weeks |
| Incidence of adverse events of the four drugs used in the preventive treatment of migraine . | Number of adverse events | 12 weeks |
| D009422 | Nervous System Diseases |
| Carbohydrates |
| D007661 | Ketoses |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |