Clinical trial for Migraine
Official title New Methods for Evaluating Preventive Migraine Treatment
ClinicalTrials.gov ID: NCT07071506
What this study is testing
What is Fremanezumab?
This is an investigational injectable medicine being studied for the treatment of chronic migraine. It is designed to block a specific protein called CGRP that helps send pain signals during a migraine.
Also referred to as Ajovy.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if patients react differently to migraine medicine depending on whether they think they are taking the real drug or a placebo (a sugar pill). It also looks at how side effects change based on this information.
- Who it's for
- People who have chronic migraine, which means having frequent migraines.
- What's involved
- Participants will take part in a test where they receive four different treatment conditions in a random order. This includes both real medicine and fake pills to compare reactions.
- Time commitment
- The source text does not specify the total duration or the number of visits required.
- Time commitment: about 8 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Adults (18-65 years)
- ≥ 1-year history of migraine with or without aura according to the International Classification of Headache Disorders (ICHD-3) diagnostic criteria
- Known chronic migraine (headache occurring ≥ 15 days per month for \> 3 months, which on at least 8 days per month has the features of migraine...
- Eligibility for preventive migraine treatment
- Ability to speak and read Danish
You likely can't join if
- Use of onabotulinumtoxinA as preventive migraine treatment during the 4 months before inclusion
- Use of other preventive migraine treatment except CGRP antagonists (However, participants are allowed to be on two stable preventive medication...
- Use of opioid or barbiturate medications in the last four weeks before inclusion
- Secondary headache disorders including medication overuse headache
- Severe psychiatric, vascular disease, or known liver disease
- Alcohol abuse or substance abuse
See the full eligibility criteria
- Adults (18-65 years)
- ≥ 1-year history of migraine with or without aura according to the International Classification of Headache Disorders (ICHD-3) diagnostic criteria
- Known chronic migraine (headache occurring ≥ 15 days per month for \> 3 months, which on at least 8 days per month has the features of migraine headache) diagnosed before age 65
- Eligibility for preventive migraine treatment
- Ability to speak and read Danish
- Use of onabotulinumtoxinA as preventive migraine treatment during the 4 months before inclusion
- Use of other preventive migraine treatment except CGRP antagonists (However, participants are allowed to be on two stable preventive medication (antidepressant, calcium channel blockers, beta blockers or antiepileptic)-...
- Use of opioid or barbiturate medications in the last four weeks before inclusion
- Secondary headache disorders including medication overuse headache
- Severe psychiatric, vascular disease, or known liver disease
- Alcohol abuse or substance abuse
- Current or planned pregnancy and lactation
The study team makes the final eligibility decision.
Where it is enrolling
- Aarhus C, Denmark, Denmark
- Aarhus N, Denmark, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 8 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Aarhus C, Denmark, Denmark; Aarhus N, Denmark, Denmark. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.