Migraine Trial, Recruiting NCT07029126 Sponsor: Fondazione Policlinico Universitario Campus Bio-Medico Condition: Migraine
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Migraine Trial, Recruiting

NCT07029126
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

For patients with migraine:

  • Adults (male or female) who have been diagnosed with migraine (with or without aura) or chronic migraine, according to standard medical guidelines
  • People whose migraine began before the age of 50
  • People who have some symptoms of depression, measured by a standard questionnaire called the PHQ-9 with a score of 5 or higher
  • People who can provide a clear record of their migraine history and how many migraine days they had in the past month
  • People for whom a doctor has determined that a medication called fremanezumab is an appropriate treatment to help prevent migraines, and who have not previously used this type of medication (monoclonal antibodies targeting the CGRP pathway)
  • People already taking migraine prevention medication and/or antidepressants, provided those treatments have been stable for at least 8 weeks before joining the trial
  • People who have an informal caregiver living with them (as defined below)
  • People who can complete a daily diary at least 80% of the time and are able to give written consent to participate

For informal caregivers:

  • Adults (male or female) who are a spouse, partner, parent, child, or sibling of the migraine patient
  • People who live in the same household as the patient and help with daily needs and activities
  • People who score 1 or higher on the RSS (a caregiver burden questionnaire)
  • People who can complete study questionnaires at least 80% of the time and are able to give written consent to participate

Who may not be able to join:

For patients with migraine:

  • People who do not have a caregiver living with them
  • People for whom fremanezumab is not suitable or not recommended as a treatment
  • People who have a significant ongoing illness affecting the blood, heart, kidneys, hormones, lungs, digestive system, urinary system, nervous system, liver, or eyes, or who have serious complications from an infection (as assessed by the study doctor)
  • People with a history of a serious or poorly controlled psychiatric condition such as bipolar disorder, schizophrenia, or psychosis, where this could interfere with taking part in the study (as assessed by the study doctor)
  • People who are already taking part in another clinical trial at the same time

For informal caregivers:

  • People who have a personal history of migraine
  • People with a history of major depression or a serious or poorly controlled psychiatric condition such as bipolar disorder, schizophrenia, or psychosis, where this could interfere with taking part in the study (as assessed by the study doctor)
  • People who have a significant ongoing illness affecting the blood, heart, kidneys, hormones, lungs, digestive system, urinary system, nervous system, liver, or eyes, or who have serious complications from an infection (as assessed by the study doctor)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: +3906225411270

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Fondazione Policlinico Universitario Campus Bio-Medico
Registry
ClinicalTrials.gov
Start date
3 October 2024
Est. completion
30 October 2025

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

CHANGE in caregiver stress

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov