Ongoing Clinical Trials for Torticollis
Currently, there are 2 ongoing clinical trials investigating new treatments for torticollis, also known as cervical dystonia. These trials are testing botulinum toxin-based therapies in several European countries including Germany, Italy, Poland, Spain, France, Czechia, and Finland. The studies aim to improve symptom control and quality of life for adults living with this neurological condition that causes involuntary neck muscle contractions.
Clinical trial locations
- Czechia
- Finland
- France
- Germany
- Italy
- Poland
- Spain
Study on IPN10200 for Treating Cervical Dystonia in Adults
This trial is investigating a new injectable treatment called IPN10200, which contains botulinum neurotoxin serotype A/B, for adults with cervical dystonia. The condition causes involuntary muscle contractions in the neck, leading to abnormal head and neck positions.
Who can participate: Adults aged 18 years or older with a confirmed diagnosis of isolated cervical dystonia are eligible. Symptoms must be at least moderate in severity, measured by specific scores on the Toronto Western Spasmodic Torticollis Rating Scale. This includes a total score of 20 or higher, a severity subscale score of 15 or higher, a disability subscale score of 3 or higher, and a pain subscale score of 1 or higher. Both people who are new to botulinum toxin therapy and those who have previous experience with it can join.
Who cannot participate: People with other significant medical conditions that might interfere with the study, those who have had recent surgery or are planning surgery during the study, and those currently participating in another clinical trial are excluded. People with known allergies to the study medication or its ingredients, pregnant or breastfeeding women, individuals with a history of drug or alcohol abuse within the past year, and those who have received other treatments for cervical dystonia within a certain period before the study starts cannot participate. People with a history of certain neurological disorders or those unable to comply with study procedures are also excluded.
What the trial involves: Participants are randomly assigned to receive either IPN10200 or a placebo injection into the affected neck muscles. This is a double-blind study, meaning neither participants nor the study team know who receives which treatment. The main goal is to evaluate how well IPN10200 reduces symptoms, particularly at week 4 after injection. Participants will be monitored through regular follow-up visits until week 36, during which changes in symptoms, pain levels, and effects on daily activities will be assessed. Safety monitoring includes checks for side effects, vital signs, laboratory tests, and physical examinations.
Investigational drug: IPN10200 is being tested to see if it can reduce symptoms of cervical dystonia by targeting specific pathways in the nervous system to help relax muscles and reduce abnormal movements. It works as a neuromodulator, helping to regulate nerve activity.
Study on the Effectiveness of Botulinum Toxin Type A for Patients with Cervical Dystonia and Abnormal Muscle Activity
This Finnish trial is exploring whether people with cervical dystonia also have abnormal muscle activity in their back muscles, and if so, whether treating those back muscles with botulinum toxin injections can help improve symptoms.
Who can participate: Adults over 18 years old who have cervical dystonia with unusual muscle activity in the neck and shoulder area causing abnormal head positioning are eligible. Participants must already be receiving regular botulinum toxin treatment for their condition and must voluntarily agree to participate after being fully informed about the study.
Who cannot participate: Individuals not experiencing abnormal muscle activity in the neck area, those not primarily treated with local botulinum toxin injections, and those without abnormal muscle activity in the chest and lower back areas are excluded. People outside the age range of 18 to 65 years and those belonging to vulnerable populations requiring special protection or care cannot participate.
What the trial involves: After providing informed consent, participants undergo an initial assessment to evaluate muscle activity in the neck and back. The treatment phase involves intramuscular injections of botulinum toxin type A using either Botox or Xeomin in 50 or 100 unit doses. The injections aim to temporarily weaken targeted muscles to reduce abnormal activity. Some participants may receive a placebo. Regular follow-up visits monitor the effectiveness of treatment and any side effects, with assessments using the Unified Dystonia Rating Scale to measure changes in dystonia severity. The study is expected to conclude by June 30, 2026.
Investigational drugs: The trial uses botulinum toxin type A (available as Botox and Xeomin) injected into back muscles to evaluate effectiveness and possible side effects in people with cervical dystonia who have abnormal back muscle activity. At the molecular level, botulinum toxin blocks the release of acetylcholine, a neurotransmitter necessary for muscle contraction, thereby temporarily paralyzing targeted muscles.
Summary
Both ongoing clinical trials focus on refining botulinum toxin treatments for adults with cervical dystonia. The first trial, conducted across six European countries (Germany, Italy, Poland, Spain, France, and Czechia), is testing a new formulation called IPN10200 that combines two types of botulinum neurotoxin. This multi-country approach allows for a larger and more diverse participant group.
The second trial, based in Finland, takes a different approach by investigating whether treating abnormal muscle activity in the back muscles, in addition to neck muscles, can improve outcomes for people with cervical dystonia. This reflects growing interest in understanding how the condition affects muscles beyond the neck area.
Both studies use the well-established method of botulinum toxin injections but explore different aspects of treatment optimization. They share similar inclusion criteria requiring moderate to severe symptoms and exclude people with certain medical conditions or those unable to follow study procedures. These trials aim to improve symptom control and quality of life for people living with this challenging neurological condition.
