Clinical trial to compare the effectiveness of migraine’s preventive treatments in primary care

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Institut Universitari D Investigacio En Atencion Primaria Jordi Gol

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

29 Apr 2025 → ongoing

Decision date (initial)

2024-10-03

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-513597-22-00

ClinicalTrials.gov

NCT06499116

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

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

Secondary objectives 11

1. Calculate the rate of responders (reduction of at least 50% in monthly migraine days compared to baseline)
2. Evaluate effectiveness before completing the clinical trial
3. Estimate the reduction in the intensity of migraine attacks
4. Estimate the prevalence of symptoms associated with migraine
5. Evaluate adherence to preventive treatment
6. Estimate the reduction in the use of symptomatic treatment drugs used to treat migraine attacks (analgesics, NSAIDs, triptans, others).
7. Evaluate reconsultation visits due to migraine attacks
8. Evaluate improvement in quality of life and patient satisfaction
9. Analyze the differences between men and women.
10. Estimate the disability associated with migraine attacks according to temporary work disability, absenteeism, presenteeism.
11. To evaluate the safety of the four drugs used in the preventive treatment of migraine.

Conditions and MedDRA coding

Migraine

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 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.

Exclusion criteria 9

1. People diagnosed with migraine who are not candidates for preventive migraine treatment
2. People diagnosed with chronic migraine (>15 days of headache per month, of which 8 are monthly migraine days)
3. Not having a smartphone
4. Simultaneous participation in another clinical trial
5. Pregnancy or expected pregnancy during the next 3 months
6. Lactation
7. People with migraine who already receive preventive treatment.
8. People on chronic treatment with opioids or other analgesics or NSAIDs that are not used for the symptomatic treatment of migraine, for example, osteoarthritis.
9. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 13

1. 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.
2. Change in mean number of MMDs at 4 and 8 weeks from baseline.
3. Reduction in the mean number of moderate-severe MMD at 4, 8 and 12 weeks from the start of treatment.
4. Proportion of patients with associated symptoms at 12 weeks from the start of treatment; photophobia, phonophobia, nausea.
5. 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.
6. Change in the mean number of drugs used for symptomatic treatment at 4, 8 and 12 weeks from baseline.
7. 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.
8. Patients' Global Impression of Change (PGIC) scale at 12 weeks.
9. Change in EQ-5D-5L questionnaire at 12 weeks from baseline.
10. Change in HIT-6 questionnaire at 12 weeks from baseline.
11. Change in the number of ILT days, absenteeism, presenteeism at 12 weeks from the start of treatment.
12. Adherence to treatment 6 months after the start of the trial.
13. Switching or discontinuation of drug for preventive treatment after 6 months from the start of the trial.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Institut Universitari D Investigacio En Atencion Primaria Jordi Gol

Sponsor organisation

Institut Universitari D Investigacio En Atencion Primaria Jordi Gol

Address

Gran Via De Les Corts Catalanes 587

City

Barcelona

Postcode

08007

Country

Spain

Scientific contact point

Organisation

Institut Universitari D Investigacio En Atencion Primaria Jordi Gol

Contact name

Maria Giner-Soriano

Public contact point

Organisation

Institut Universitari D Investigacio En Atencion Primaria Jordi Gol

Contact name

Ramon Monfà

Locations

1 EU/EEA country · 16 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications