NCT06628921

Brief Summary

A perspective and multicentric study to evaluate the efficacy of eptinezumab administered during a migraine attack. During the intravenous infusion of eptinezumab, some patients experiencing an ongoing migraine attack report its resolution. This finding is known in the literature, having been described in the RELIEF study. This study was designed to also evaluate, in a real-world setting, the efficacy of eptinezumab in resolving the ongoing attack and the time frame within which the attack is resolved. The study includes all patients who will begin treatment according to clinical practice, and are included in the TACHIS study (NCT06409845, Unique protocol ID RICe\_5)

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
5mo left

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Oct 2024Oct 2026

First Submitted

Initial submission to the registry

October 3, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
22 days until next milestone

Study Start

First participant enrolled

October 30, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2026

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

October 3, 2024

Last Update Submit

January 19, 2026

Conditions

Migraine

Keywords

headachePainmigraineEptinezumab

Outcome Measures

Primary Outcomes (1)

  • Time to Headache Pain Freedom

    Time to headache pain freedom defined as the time that the participant reported freedom of pain, meaning their headache pain had gone from moderate to severe at baseline to no pain.

    Up to 48 hours postdose

Secondary Outcomes (5)

  • Time to Absence of Most Bothersome Symptom (MBS)

    Up to 48 hours postdose

  • Headache Pain Freedom at 2 Hours

    2 hours

  • Absence of MBS at 2 Hours

    2 hours

  • Headache Pain Freedom and absence of MBS

    Up to 48 hours postdose

  • Use of Rescue Medication

    Up to 48 hours postdose

Study Arms (2)

Episodic migraine

Patients affected by migraine with an episodic pattern (\< 15 monthly migraine days) with or without aura according to ICHD-III criteria with ongoing migraine attack.

Drug: Eptinezumab 100 or 300 mg ev

Chronic migraine

Group/Cohort Description: atients affected by chronic migraine (\> 15 monthly headache days with at least 8 days with migraine features) according to ICHD-III criteria with ongoing migraine attack.

Drug: Eptinezumab 100 or 300 mg ev

Interventions

Eptinezumab 100 or 300 mg evDRUG

Eptinezumab administered for migraine prevention in patients but with ongoing migraine attacks.

Also known as: Eptinezumab
Chronic migraineEpisodic migraine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Multicentric study on patients attending the outpatient clinic of Italian Headache centres who meet criteria for eptinezumab use as migraine preventive treatment

You may qualify if:

  • Diagnosis of migraine without aura, migraine with aura, or chronic migraine according to the third edition of the ICHD (ICHD-III).
  • At least 8 days of migraine per month.
  • Adequate compliance with study procedures.
  • Availability of a migraine diary for at least one month prior to enrollment.
  • Ongoing attack before administration.
  • Included in the TACHIS study (NCT06409845)

You may not qualify if:

  • Subjects with contraindications to the use of eptinezumab.
  • Concomitant diagnosis of medical conditions and/or comorbidities that, in the investigator's opinion, could interfere with the study's assessments and outcomes.
  • Pregnancy and breastfeeding.
  • Changes in concomitant preventive therapy in the month prior to the initiation of eptinezumab.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Campus Biomedico

Roma, Italy

RECRUITING

Related Publications (1)

  • Winner PK, McAllister P, Chakhava G, Ailani J, Ettrup A, Krog Josiassen M, Lindsten A, Mehta L, Cady R. Effects of Intravenous Eptinezumab vs Placebo on Headache Pain and Most Bothersome Symptom When Initiated During a Migraine Attack: A Randomized Clinical Trial. JAMA. 2021 Jun 15;325(23):2348-2356. doi: 10.1001/jama.2021.7665.

    PMID: 34128999BACKGROUND

MeSH Terms

Conditions

Migraine DisordersHeadachePain

Interventions

eptinezumab

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Fabrizio Vernieri, MD

CONTACT

06 225411F.Vernieri@policlinicocampus.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

October 3, 2024

First Posted

October 8, 2024

Study Start

October 30, 2024

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

October 30, 2026

Last Updated

January 21, 2026

Record last verified: 2026-01

Locations

IT(1)