Real-world Effectiveness and Tolerability of Triptans-Ditans-Gepants (TRIDIGEP)

NCT06267664 | Recruiting FDA Drug

• 1 other identifier: PI-GR-23-3263
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

Migraine is the third most prevalent disease and the leading reason of years lived with disability in the most productive years of the life. Migraine associated disability can be alleviated by acute and preventive treatment. The migraine landscape has changed recently, with the approval of novel acute treatments, including oral Calcitonin gene-related peptide antagonists, the gepants (Rimegepant, Ubrogepant, Zavegepant) and 5-HT-1F antagonists, the Ditans (Lasmiditan). These have joined Triptans as acute "migraine-specific" drugs. The TRIDIGEP study will be an open-label, multiple attack, prospective cohort study. This study aims to describe 1) the effectiveness of the acute treatments of migraine attacks in routine clinical practice, 2) the tolerability of the drugs, and 3) to explore potential response and tolerability predictors. The endpoints recommended by the International Headache Society will be employed, including: 1) Pain freedom; 2) Absence of the most bothersome symptom; 3) Sustained pain freedom; 4) Total freedom from migraine; 5) Headache relief; 6) Duration of attacks; 7) Time lost due to an attack; 8) Need of rescue medication. The study endpoints will be assessed at 2, 8 and 24 hours after the acute drug use. Data will be collected by the patients themselves, with a validated data collection instrument within a RedCap questionnaire, using QR codes.

Conditions

Migraine; Migraine Disorders; Migraine With Aura; Headache Disorders

Keywords

Triptans; Lasmiditan; Gepants

Outcome Measures

Primary Outcomes (2)

• Pain freedom at 2 hours

  The percentage of subjects who become pain free at two hours after treatment, before the use of any rescue medication

  Two hours after treatment intake

• Absence of the most bothersome symptom

  Absence of the most bothersome migraine-asso- ciated symptom at 2 hours after treatment

  Two hours after treatment intake

Secondary Outcomes (20)

• Pain freedom at 8 hours

  Eight hours after treatment intake

• Pain freedom at 24 hours

  24 hours after treatment intake

• Sustained pain freedom

  Twenty-four hours after treatment intake

• Total freedom from migraine at 2 hours

  Two hours after treatment intake

• Total freedom from migraine at 8 hours

  Eight hours after treatment intake

Study Arms (1)

Patients with migraine treated with triptans, Lasmiditan or Gepants

Patients that fulfill the criteria for migraine, according to the International Classification of Headache Disorders, 3rd version treated with triptans, Lasmiditan or Gepants as acute therapies according to their responsible physician criteria under routine clinical practice criteria

Drug: Patients with migraine treated with triptans, Lasmiditan or Gepants

Interventions

Patients with migraine treated with triptans, Lasmiditan or Gepants DRUG

Patients will complete the study information in their smartphones, tablets or computers, using a QR code or a link that will redirect hem to the study questionnaires. RedCap will be used in the study.

Patients with migraine treated with triptans, Lasmiditan or Gepants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be adult patients with migraine, according to the International Headache Society criteria. Eligible patients will be trained in the use of the data collection instruments. They will be asked to record the study variables whenever they use the investigated drug products, for at least one attack, but ideally for every attack that they use the drug, ideally for at least five different attacks.

You may qualify if:

• Fulfill the criteria for migraine, according to the International Classification of Headache Disorders, 3rd version;
• Treatment with triptans, Lasmiditan or Gepants as acute therapies according to their responsible physician criteria under routine clinical practice criteria;
• Participant have a smartphone, tablet, or computer with an internet connection;
• Participant accept to participate and sign the informed consent form

You may not qualify if:

• Patient have a concomitant use of opioids, barbiturates, or ergot derivates;
• Participant have major cognitive or psychiatric disorder;
• Participants are unable to describe the result of the employed drug
• Participants have an insufficient proficiency of the local languages.

Sponsors & Collaborators

• Hospital Clínico Universitario de Valladolid: lead

Study Sites (1)

Hospital Clínico Universitario de Valladolid

Valladolid, 47010, Spain

RECRUITING

Related Publications (22)

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  PMID: 30496104 RESULT

Related Links

• European Medicines Agency: Vydura: EPAR - Medicine Overview. Publicado el 11.05.2022
• European Medicines Agency: Rayvow: EPAR - Medicine Overview. Publicado el 03.10.2022
• Santos Lasaosa S, Pozo Rosich P. Manual de Práctica Clínica en Cefaleas. Recomendaciones Diagnóstico- Terapéuticas de la Sociedad Española de Neurología 2020. Ediciones SEN. ISBN: 978-84-18420-19-1.

MeSH Terms

Conditions

Migraine Disorders; Migraine with Aura; Headache Disorders

Interventions

Tryptamines; lasmiditan; Calcitonin Gene-Related Peptide Receptor Antagonists

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Central Nervous System Agents; Therapeutic Uses

Central Study Contacts

David García Azorín, MD, PhD

CONTACT

+34665872228; davilink@hotmail.com

Yesica González Osorio

CONTACT

634330426; yesgonzalezosorio@outlook.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 14 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Headache Unit, Department of Neurology

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 20, 2024
• Study Start: December 4, 2023
• Primary Completion: September 30, 2024
• Study Completion: December 1, 2024
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

ES (1)