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Study on the Safety and Effectiveness of IPN10200 for Treating Upper Limb Spasticity in Adults After Stroke or Brain Injury

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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 the treatment of upper limb spasticity, a condition that can occur after a stroke or traumatic brain injury. The study is testing a new medication called IPN10200, which is a type of botulinum toxin. This medication is being compared to another botulinum toxin product called Dysport, as well as a placebo. The purpose of the study is to evaluate the safety and effectiveness of IPN10200 in treating upper limb spasticity.

The study is conducted in several stages. Initially, different doses of IPN10200 are tested to find the safest and most effective dose. Participants receive a single injection of the medication, and their response is monitored. In later stages, the selected doses are further tested to confirm their safety and effectiveness. The study also includes an open-label extension period, where participants who have completed the earlier stages can continue to receive IPN10200 to assess its long-term safety and benefits.

Throughout the study, participants are closely monitored for any side effects or changes in their condition. The study aims to find the best dose of IPN10200 that provides the desired relief from spasticity while ensuring safety. This research could lead to improved treatment options for individuals experiencing upper limb spasticity after a stroke or traumatic brain injury.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, participants will be randomly assigned to receive either the new treatment, IPN10200, or a placebo. This process is double-blind, meaning neither the participant nor the study team will know which treatment is being administered.

    Participants will receive a single injection of the assigned treatment into the muscle, which is known as intramuscular use.

  2. Step 2

    Stage 1: dose escalation

    In this stage, the safety and tolerability of increasing doses of IPN10200 will be assessed. Participants will be monitored for any side effects and the effectiveness of the treatment.

    The goal is to select two dose levels for further investigation in the next stage.

  3. Step 3

    Stage 2: dose finding

    Participants will receive one of the two doses of IPN10200 selected from Stage 1. The safety and effectiveness of these doses will be compared to a standard treatment called Dysport.

    The aim is to identify the lowest dose that is both safe and effective for further study.

  4. Step 4

    Stage 3: efficacy assessment

    This stage focuses on evaluating how well IPN10200 works compared to a placebo in treating upper limb spasticity.

    Participants will be assessed for improvements in muscle stiffness and overall treatment response.

  5. Step 5

    Open-label extension period

    Participants from Stage 3 may continue to receive IPN10200 in an open-label format, meaning both the participant and the study team will know the treatment being administered.

    This period allows for the observation of long-term safety and effectiveness over multiple treatment cycles.

Who can join the trial?

15 criteria

  • Participant must be between 18 and 70 years old. If participating in dose escalation, the age range is 18 to 65 years.
  • Participant must be in good health, meaning no uncontrolled diseases or significant medical conditions, as determined by medical history and various health examinations.
  • Both men and women can participate. Contraceptive use must follow local regulations:
    • Male participants: If their partner can become pregnant, they must use an effective method of contraception during the study.
    • Female participants: Must not be pregnant or breastfeeding. They must either be unable to have children or use an acceptable contraceptive method during the study. A negative pregnancy test is required before participation.
    • Participant must be able to give signed informed consent, agreeing to follow the study's requirements and restrictions.
    • Participant must have spastic hemiparesis (muscle stiffness on one side of the body) following a stroke or traumatic brain injury (TBI).
    • Participant must be at least 6 months post-stroke or TBI.
    • Participant must not have received BoNT (Botulinum Toxin) treatment before, or if previously treated, the last injection must have been at least 4 months before the study starts.
    • Participant must have a Modified Ashworth Scale (MAS) score of 2 or more in the muscle group to be injected. The MAS is a measure of muscle spasticity.
    • Participant must be eligible to receive a total recommended dose of 1000 units of Dysport in the upper limb, if applicable.
    • Participant must have an angle of spasticity of 5 degrees or more in the muscle group to be injected.
    • Participant must have a specific angle of arrest as measured by the Tardieu scale in the muscle groups to be injected:
      • 160 degrees or more for finger flexors
      • 90 degrees or more for wrist flexors
      • 160 degrees or more for elbow flexors
      • For Stages 1 and 2, any physiotherapy, occupational therapy, splinting, or use of muscle relaxants must be stable for at least 30 days before the study starts and continue until the Month 3 visit, and if possible, until the end of the study. For Stage 3, these treatments must be stable for at least 3 months before the study starts.

Who cannot join the trial?

5 criteria

  • Patients who have not experienced a **stroke** or **traumatic brain injury** affecting the upper limb.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specified clinical trial groups.
  • Patients who are not male or female, as both genders are included in the study.
  • Patients who are not considered part of a **vulnerable population**. This term refers to groups who may be at a higher risk of harm or exploitation in a clinical trial, such as children, pregnant women, or those with cognitive impairments.
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Investigated drugs

  • IPN10200

    is an experimental treatment being tested in this clinical trial. It is designed to help manage upper limb spasticity, which is a condition where muscles in the arm become stiff and difficult to move. The trial is exploring how safe and effective this treatment is when given in different amounts. The goal is to find the best dose that helps reduce muscle stiffness while being safe for patients to use over time.

  • Dysport

    is a medication already used to treat muscle stiffness in conditions like upper limb spasticity. It works by relaxing the muscles, making them less stiff and easier to move. In this trial, Dysport is used as a comparison to see how well the new treatment, IPN10200, works in reducing muscle stiffness and improving movement in the arms.

What is already known about the treatment

IPN10200 – IPN10200 is administered as an injection to treat upper limb spasticity, which can occur after a stroke or traumatic brain injury. Currently, it is being studied in clinical trials to determine its safety and effectiveness compared to a placebo and another medication called Dysport. The main goal is to find the best dose that is both safe and effective. IPN10200 works by targeting specific muscles to reduce excessive muscle contractions, helping to improve movement and reduce discomfort. It is classified as a neuromuscular blocking agent, which means it helps to relax muscles.

Investigated diseases

Upper limb spasticity after stroke or traumatic brain injury – This condition involves increased muscle tone and stiffness in the upper limbs, often occurring after a stroke or traumatic brain injury. It results from damage to the brain or spinal cord, which disrupts normal communication between the brain and muscles. As a result, muscles in the arms and hands may become tight and difficult to move. The condition can lead to difficulty with everyday tasks such as dressing, eating, and writing. Over time, if not managed, it can cause muscle shortening and joint deformities. The severity of spasticity can vary, and it may change over time, sometimes improving or worsening.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2023-507202-14-00Protocol codeD-FR-10200-001Estimated enrolment349 patientsSponsorIpsen Innovation

sourced from the EU Clinical Trials Register and site verification

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