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Study on IPN10200 for Treating Cervical Dystonia in Adults

Fast replyInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Cervical Dystonia, which affects the muscles in the neck, causing involuntary contractions and abnormal movements or postures. The study is testing a new treatment called IPN10200, which is a solution for injection containing a substance known as Clostridium botulinum, neurotoxin serotype A/B. This treatment is being compared to a placebo to see how effective it is in reducing the symptoms of cervical dystonia.

The purpose of the study is to evaluate how well IPN10200 works in reducing the symptoms of cervical dystonia in adults. Participants in the study will receive either the IPN10200 injection or a placebo. The study will monitor changes in symptoms over time, with a particular focus on the first four weeks after treatment. Participants will be assessed at various points up to 36 weeks to track any changes in their condition and to monitor for any side effects.

Throughout the study, participants will be asked to report on their symptoms, including pain levels and how the condition affects their daily activities. The study will also look at how quickly participants experience relief from symptoms and how long the effects of the treatment last. Safety will be closely monitored, including any potential side effects or changes in health status. The goal is to gather comprehensive information on the effectiveness and safety of IPN10200 as a treatment option for cervical dystonia.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit and screening

    Upon joining the study, an initial visit is conducted to confirm eligibility. This involves a clinical diagnosis of cervical dystonia, which affects the head, neck, and shoulders. The severity of symptoms is assessed using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS).

    The TWSTRS measures the severity, disability, and pain associated with cervical dystonia. Scores must meet specific criteria to proceed.

  2. Step 2

    Randomization and treatment assignment

    Participants are randomly assigned to receive either the study medication IPN10200 or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is given.

    The medication is administered as a solution for injection into the muscles, specifically designed for intramuscular use.

  3. Step 3

    Treatment administration

    The study medication or placebo is injected at the start of the trial. The goal is to assess the effectiveness of IPN10200 in reducing symptoms of cervical dystonia.

    Participants will be monitored for changes in symptoms, particularly at week 4 after the injection.

  4. Step 4

    Follow-up visits and assessments

    Regular follow-up visits are scheduled to monitor progress and assess any changes in symptoms. These visits continue until week 36.

    During these visits, various scales and questionnaires are used to evaluate symptom changes, including the TWSTRS and the Numerical Rating Scale (NRS) for pain.

  5. Step 5

    Monitoring and safety assessments

    Throughout the trial, participants are monitored for any adverse events or side effects. This includes regular checks of vital signs, laboratory tests, and physical examinations.

    The presence of any antibodies to the study medication is also assessed to ensure safety and effectiveness.

  6. Step 6

    Final evaluation and study completion

    At the end of the study period, a final evaluation is conducted to assess the overall impact of the treatment on cervical dystonia symptoms.

    Participants' experiences and outcomes are documented to contribute to the study's findings on the efficacy and safety of IPN10200.

Who can join the trial?

8 criteria

  • Must have a clinical diagnosis of isolated Cervical Dystonia (CD), which is a condition affecting the muscles in the neck, head, and shoulders.
  • Symptoms must be at least moderate in severity, as measured by specific scores on the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS):
    • Total score of 20 or higher
    • Severity subscale score of 15 or higher
    • Disability subscale score of 3 or higher
    • Pain subscale score of 1 or higher
    • Can be either new to or experienced with BoNT therapy for Cervical Dystonia. BoNT therapy refers to treatments using botulinum toxin.
    • Must be an adult, aged 18 years or older.
    • Both males and females are eligible to participate.

Who cannot join the trial?

9 criteria

  • Patients with any other significant medical condition that might interfere with the study.
  • Patients who have had a recent surgery or are planning to have surgery during the study period.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a known allergy or sensitivity to the study medication or its ingredients.
  • Patients who are pregnant or breastfeeding.
  • Patients with a history of drug or alcohol abuse within the past year.
  • Patients who have received any other treatment for Cervical Dystonia within a certain period before the study starts.
  • Patients with a history of certain neurological disorders, which are conditions affecting the brain, spine, and nerves.
  • Patients who are unable to comply with the study procedures or follow-up visits.
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Investigated drugs

IPN10200 is a medication being studied for its potential to help people with cervical dystonia, a condition that causes involuntary muscle contractions in the neck. This medication is being tested to see if it can reduce the symptoms of cervical dystonia, such as neck pain and abnormal head positions. The goal of the study is to determine if IPN10200 can improve the quality of life for people suffering from this condition by making their symptoms less severe.

What is already known about the treatment

IPN10200 – IPN10200 is administered as an injection to treat cervical dystonia, a condition characterized by involuntary muscle contractions in the neck. Currently, IPN10200 is being studied in clinical trials to determine its effectiveness and safety for this condition. The main therapeutic indication for IPN10200 is to reduce the symptoms of cervical dystonia in adults. At the molecular level, IPN10200 works by targeting specific pathways in the nervous system to help relax the muscles and reduce abnormal movements. It is classified pharmacologically as a neuromodulator, which means it helps to regulate nerve activity.

Investigated diseases

Cervical Dystonia – Cervical Dystonia is a neurological disorder characterized by involuntary muscle contractions in the neck, leading to abnormal movements and awkward postures of the head and neck. These muscle contractions can cause the head to twist or tilt to one side, forward, or backward. The condition often results in discomfort and pain due to the sustained muscle contractions. Symptoms can vary in severity and may fluctuate over time, sometimes worsening with stress or activity. The disorder can affect daily activities and quality of life, as the abnormal postures can be persistent or intermittent. The exact cause of Cervical Dystonia is not well understood, but it is believed to involve dysfunction in the brain areas that control movement.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519248-34-00Protocol codeCLIN-10200-457Estimated enrolment135 patientsSponsorIpsen Innovation

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).