RecruitingPHASE2INTERVENTIONAL

A Study of IPN10200 for the Treatment of Cervical Dystonia in Adults

This research study is looking at a new medication, IPN10200, for adults living with cervical dystonia. This condition causes uncomfortable head and neck movements, pain, and stiffness. Current treatments often involve injections that only last about three months. The study wants to find out if IPN10200 is safe and effective in treating cervical dystonia, and if its effects might last longer. Participants will receive either IPN10200 or a placebo (a dummy drug) and be monitored over approximately nine months, including regular clinic visits, physical checks, and questionnaires, to see how the new drug compares to no treatment. This is a Phase 2 trial, meaning it's an early stage of testing.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Ipsen

Enrolment target

132

Start

30 Jun 2025

Estimated completion

05 Nov 2027

Cervical Dystonia

What is this study about?

Cervical dystonia is a condition where your neck muscles uncontrollably contract, causing your head to twist, turn, or tilt in uncomfortable ways. This can lead to pain, stiffness, and headaches. While we don't fully understand why it happens, it's thought to be linked to parts of the brain that control movement, and sometimes genetic or environmental factors might play a role.

Currently, a common treatment for cervical dystonia involves injections of a medicine called BoNT directly into the affected muscles. However, these injections typically only help for about three months, meaning patients need to return for regular treatments. This study is testing a new medicine called IPN10200, which is designed to potentially last for a longer period of time, offering a more convenient and perhaps more stable treatment option for people with this condition.

The main goal of this study is to carefully check if IPN10200 is both safe to use and effective at reducing the symptoms of cervical dystonia, like neck pain and stiffness. Researchers will also compare IPN10200 to a 'placebo', which looks like the study drug but doesn't contain any active medicine. This comparison helps them understand if any improvements seen are truly due to IPN10200.

Key takeaways

This study is testing a new drug, IPN10200, for adults with cervical dystonia.
The goal is to see if IPN10200 is safe, effective, and potentially longer-lasting than current treatments.
Participants will receive either IPN10200 or a placebo (dummy drug).
The study involves regular clinic visits, medical checks, and questionnaires over about 9 months.
It's for adults aged 18-80 with moderate cervical dystonia symptoms.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you must be an adult between 18 and 80 years old with a clear diagnosis of cervical dystonia. Your dystonia should mainly affect your head, neck, and shoulder areas and be causing at least moderate symptoms, as measured by specific medical assessments at the start of the study.

It doesn't matter if you've had BoNT injections for your cervical dystonia before or not. Both people who have received this treatment and those who haven't might be able to take part.

However, there are certain reasons why you wouldn't be able to join. For example, if you have severe swallowing difficulties, or if your cervical dystonia is mainly causing your head to strongly tilt forwards (anterocollis) or backwards (retrocollis), you wouldn't be eligible. Also, if your neck problems are due to an injury or other structural issues, or if your neck movement is very limited because of stiffness, you likely couldn't participate.

Quick self-check

Are you between 18 and 80 years old?
Have you been diagnosed with cervical dystonia?
Does your cervical dystonia mainly affect your head, neck, and shoulders?
Are your symptoms currently at least moderately severe?
Do you have severe swallowing problems?
Is your cervical dystonia primarily an extreme forward or backward head tilt, or due to an injury/other neck issues?

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, your total involvement in the study will last for up to 40 weeks, which is about 9 months. First, there's a screening period of up to 4 weeks (about a month) with at least one visit to check if the study is right for you. If you qualify, you'll then enter a 36-week ‘treatment period’.

On your first day of treatment, you will receive injections of either IPN10200 (at one of three possible doses) or a placebo (a dummy drug without active medicine) into different muscles in your head, neck, and shoulders. During the study, you'll have 10 in-person clinic visits and one phone call. If you happen to receive one of the specific doses (Dose C), you'll have an additional two clinic visits, bringing your total to 12. At these visits, you'll have blood samples taken, provide urine samples, undergo physical and nerve examinations, and complete questionnaires about your symptoms and how you're feeling. You might also be able to continue some of your other regular medications, but the study team will need to record these details.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, like access to a new treatment that might improve your symptoms or provide longer-lasting relief than existing options. However, there are also potential risks, including side effects from the study drug, discomfort from injections, or the possibility that the treatment might not work for you as expected. Some people might experience temporary side effects like swallowing difficulties. You would receive either the active drug or a placebo, so there's no guarantee you'd get the new treatment. It's important to remember that participating in any study is entirely voluntary, and you are free to withdraw at any time without affecting your usual medical care.

Locations (44)

University of Arizona Health Sciences - Neurology
Tucson, United States· Active not recruiting
Parkinson's & Mvmt Disorders Inst
Fountain Valley, United States· Recruiting
Parkinson's Ds & Mvt Disorders Cntr
Boca Raton, United States· Recruiting
USF Health Byrd Alzheimer's Institute
Tampa, United States· Not yet recruiting
Emory Brain Health Center
Atlanta, United States· Recruiting
Rush Medical Center
Chicago, United States· Active not recruiting
Quest Research Institute
Farmington Hills, United States· Recruiting
Ichan Sch of Medicine @ Mt. Sinai
New York, United States· Recruiting
Kingfisher Cooperative
Spokane, United States· Recruiting
Fakultni nemocnice u sv. Anny v Brne - I. Neurologicka klinika
Brno, Czechia· Recruiting
MINKSneuro s.r.o.
Brno, Czechia· Active not recruiting
NEUROHK s.r.o.
Choceň, Czechia· Recruiting

+32 more sites — see the official record for the full list.

Common questions

What is cervical dystonia?

It's a condition where neck muscles contract without your control, causing your head to move into uncomfortable positions, often leading to pain and stiffness.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks like the study drug but doesn't contain any active medicine. It helps researchers see if the real drug is truly effective.

How long will the study last for me?

If you join, the study will last for up to 40 weeks, which is about 9 months from start to finish.

Will I know if I'm getting the study drug or the placebo?

During the study, you won't know if you're receiving IPN10200 or the placebo. This is standard practice in clinical trials to ensure unbiased results.

What kind of visits will I have?

You'll have about 10-12 in-person visits to the clinic and one phone call where you'll have physical checks, provide samples, and fill out questionnaires.

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.