RecruitingPHASE2INTERVENTIONAL

A Study to Evaluate IPN10200 Safety and Efficacy in the Prevention of Episodic or Chronic Migraine in Adults

This study explores a new treatment, IPN10200, for adults who experience frequent migraines. Migraines are severe headaches often with sickness and sensitivity to light/sound. IPN10200 is designed to stop certain chemicals in the brain that cause migraine pain. Researchers want to find out if injecting IPN10200 into head and neck muscles can safely and effectively reduce both episodic (Epsodic Migraine) and chronic migraines (Chronic Migraine). The study also aims to determine the best dose of the treatment. Participants will keep a daily diary and have regular check-ups over about 44 weeks.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Ipsen

Enrolment target

641

Start

10 Oct 2024

Estimated completion

31 Oct 2027

Episodic Migraine Chronic Migraine

What is this study about?

Migraines are much more than just a bad headache; they are a condition that can cause severe throbbing pain, often on one side of the head, along with feeling or being sick and being very sensitive to light and sound. They happen when specific chemicals are released in the brain, leading to pain. This study is testing a new medication called IPN10200, which aims to prevent these migraines by stopping the release of those pain-causing chemicals.

The main goals of this study are to see if IPN10200, when injected into the muscles of the head and neck, is safe and effective at preventing both episodic migraines (those that happen less often) and chronic migraines (those that happen more frequently). The researchers also want to figure out the best amount (dose) of IPN10200 to give to get the most benefit with the fewest side effects.

This is a 'Phase 2' study, meaning it's an important step in testing new medicines after initial safety checks. It will help us understand if IPN10200 has the potential to become a new way to help people manage their migraines.

Key takeaways

Tests a new injection (IPN10200) to prevent migraines.
Aims to check safety, effectiveness, and best dose.
Involves regular injections and a daily migraine diary.
Study lasts up to 44 weeks for each participant.
Compares IPN10200 to a placebo (dummy treatment).

Who may be eligible?

This study is looking for adults aged 18 to 80 who have been officially diagnosed with either episodic or chronic migraine for at least a year. You would have been diagnosed with migraine before the age of 50. You should have tried at least one other preventative migraine treatment before.

For those with episodic migraines, you should have no more than 14 headache days (migraine or non-migraine) and at least 6 migraine days in the 4 weeks before starting the main part of the study. If you have chronic migraines, you should have 15 or more headache days and at least 8 migraine days in the 4 weeks before the study starts.

However, you wouldn't be able to join if you have certain other types of headaches, like migraines with brainstem aura, or if your headaches are caused by another serious medical condition. You also would not be able to participate if you have an uncontrolled mental health condition that could affect the study or if there's a risk of self-harm. The study doctors will carefully check these and other criteria to make sure it's safe for you to take part.

Quick self-check

Are you between 18 and 80 years old?
Have you been diagnosed with migraine (episodic or chronic) for at least 12 months?
Were you diagnosed with migraine before the age of 50?
Have you tried at least one preventative migraine treatment before?
Do you get enough migraine days to meet the study criteria (checked by a doctor)?

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

What does participation involve?

If you decide to take part, the first step is a 'screening period' to make sure the study is right for you. If you qualify, you'll enter the main part of the study, which could last up to 44 weeks. During this time, you will either receive IPN10200 or a placebo (a dummy treatment) through injections into the muscles of your head, face, and neck.

The study is divided into two main steps. In Step 1, smaller groups will receive different doses of IPN10200 to check for safety. In Step 2, more participants will be randomly assigned to receive either one of two doses of IPN10200 or a placebo, and again, the treatment will be given as injections. You will be monitored closely for safety throughout, and the study team will check how well the treatment is working.

A key part of your participation will be completing a daily electronic diary (eDiary) to track your headaches and migraines. You'll also need to fill out questionnaires regularly and attend visits for injections and monitoring until your final visit at Week 36.

Potential risks and benefits

Taking part in a clinical trial like this could offer potential benefits, such as access to a new treatment before it's widely available, and close medical supervision. However, there are also potential risks, including discomfort from injections, side effects from the medication (which are not fully known yet), or receiving a placebo. While we hope the treatment will be helpful, there's no guarantee it will work for you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (166)

Central Research Associates
Birmingham, United States· Not yet recruiting
Rehabilitation & Neurological Services, LLC
Huntsville, United States· Recruiting
MD First Research - Chandler - Neurology
Chandler, United States· Recruiting
MD First Research - Chandler
Chandler, United States· Recruiting
Baptist Health Center for Clinical Research
Little Rock, United States· Withdrawn
Axiom Research, LLC
Apple Valley, United States· Not yet recruiting
Profound Research. LLC - NCSC
Carlsbad, United States· Recruiting
M3Wake -PRI Encino
Encino, United States· Recruiting
WR-PRI Encino
Encino, United States· Recruiting
Neuro-Pain Medical Center
Fresno, United States· Recruiting
Fullerton Neurological Center - Neurology
Fullerton, United States· Recruiting
Neurology Center of North Orange County
Fullerton, United States· Not yet recruiting

+154 more sites — see the official record for the full list.

Common questions

What exactly is IPN10200?

IPN10200 is a new medicine being tested to see if it can prevent migraines by stopping certain chemicals in the brain that cause pain.

How will the treatment be given?

The treatment will be given as injections into the muscles of your head, face, and neck.

Will I definitely receive the new medicine?

No, some participants will receive IPN10200, while others will receive a placebo (a dummy treatment) to compare its effects.

What do I need to do during the study?

You'll need to keep a daily electronic diary about your headaches and attend regular appointments for injections and health checks for up to 44 weeks.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, and it won't affect any future care you receive.

How to find out more

Ipsen Clinical Study Enquiries

clinical.trials@ipsen.com See e mail Official trial record

Always speak to your GP or specialist before deciding to take part in a study.