Active not recruitingPHASE3INTERVENTIONAL

A Study to Evaluate the Effectiveness and Safety of Dysport® for the Prevention of Chronic Migraine in Adults

This research study is looking into a medicine called Dysport® for adults who experience chronic migraines. Chronic migraine means having frequent headaches, including migraine attacks, very often. The study wants to find out how well Dysport® works to prevent migraines and if it's safe, compared to a placebo (a dummy treatment). Dysport® is a type of treatment that helps stop chemicals in the brain that cause pain. Participants will receive injections over about 14 months, with some getting Dysport® and others a placebo at first. There will be clinic visits and online checks, along with keeping a diary of symptoms.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Ipsen

Enrolment target

759

Start

12 Oct 2023

Estimated completion

06 Nov 2026

Chronic Migraine

What is this study about?

This study is about understanding if a medicine called Dysport® can help people who suffer from chronic migraines. A migraine is more than just a bad headache; it's often a throbbing pain, usually on one side of the head, and can come with feeling sick, throwing up, and being very sensitive to light and sound.

Someone has chronic migraine if they have headaches on 15 or more days a month, and at least 8 of those days are migraine days. Migraines happen when certain parts of the brain become overactive and release chemicals that cause pain. Dysport® is a treatment designed to block these pain-causing chemicals, which doctors hope will help prevent migraines from happening.

The main goal of this study is to see how safe Dysport® is and how well it works to reduce how often people get migraines when compared to a placebo. A placebo is like a dummy treatment that looks exactly the same as the real medicine but doesn't contain any active ingredients. This helps researchers fairly compare the effects of the new medicine.

Key takeaways

The study tests Dysport® for chronic migraine prevention.
It lasts about 14 months and involves injections and monitoring.
Some participants will first receive a placebo (dummy medicine).
You'll need regular clinic visits and fill in an e-diary.
The goal is to see if Dysport® is safe and reduces migraine frequency.

Who may be eligible?

To join this study, you need to be at least 18 years old and have been diagnosed with chronic migraine for over a year. This means you typically have headaches on 15 or more days each month, with at least 8 of those being full migraine days.

You also need to have tried other migraine prevention treatments before and found that they either didn't work for you or you couldn't continue using them. Your migraines must have started before you turned 50 years old.

There are some reasons why you might not be able to join. For example, if you have certain other types of headaches, or have recently used other specific migraine treatments like botulinum toxin for migraine within the last 24 weeks, or certain new migraine medications in the last 12 weeks, you would not be able to take part.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with chronic migraine for over a year?
Do you get headaches on at least 15 days a month, with at least 8 being migraines?
Did your migraines start before you were 50?
Have you tried other migraine prevention treatments before?
Have you avoided specific migraine treatments (like botulinum toxin or certain new medications) in recent months?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will be involved for about 14 months. First, there's a 'screening period' of 6 to 12 weeks with one visit to check if the study is right for you. Then, there are two treatment phases, each lasting 24 weeks.

During the first treatment phase, you'll have injections into muscles in your head, neck, face, and shoulders on Day 1 and again at Week 12. These injections will contain either Dysport® or a placebo (a dummy medicine). You will have 4 in-person clinic visits and 4 online check-ups. In the second treatment phase, everyone will receive Dysport® injections at Week 24 and Week 36. This phase involves 3 in-person visits and 4 online check-ups.

Throughout the study, you'll need to fill in an electronic diary and answer questionnaires. You might also have blood and urine tests, physical check-ups, and other medical assessments. While you might be able to continue some of your usual medicines, this will need to be carefully noted by the study team.

Potential risks and benefits

Participating in a study like this might offer a potential benefit if Dysport® helps to reduce your chronic migraines, or you might learn more about your condition. However, there are potential risks, as Dysport® is a medicine and could have side effects, and the injections themselves might cause discomfort. The study also involves frequent visits, tests, and keeping a diary, which might be time-consuming. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (120)

Central Research Associates
Birmingham, United States
CCT Research
Phoenix, United States
HonorHealth Neurology
Scottsdale, United States
Hope Clinical Research, LLC
Canoga Park, United States
Axiom Research LLC
Colton, United States
Fullerton Neurological Center
Fullerton, United States
Neurology Center of North Orange County
Fullerton, United States
The Los Angeles Headache Center
Los Angeles, United States
SDS Clinical Trials
Orange, United States
840011
Palo Alto, United States
Stanford University School of Medicine - Stanford Cardiovascular Institute (CVI)
Palo Alto, United States
Alliance Clinical San Diego (Acclaim Clinical Research)
San Diego, United States

+108 more sites — see the official record for the full list.

Common questions

What is chronic migraine?

Chronic migraine means getting headaches on at least 15 days each month, and at least 8 of those days are full migraine attacks.

What is Dysport®?

Dysport® is a medicine, a type of botulinum toxin, that works by stopping certain chemicals in the brain that cause pain, hoping to prevent migraines.

What is a placebo?

A placebo is a 'dummy' treatment that looks exactly like the real medicine but contains no active ingredients. It helps researchers compare the real medicine's effects fairly.

How long will the study last?

If you join, you will be part of the study for up to about 14 months in total.

Will I have to pay to be in the study?

No, you should not have to pay for any study-related procedures or the study medicine.