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Study of perineural incobotulinumtoxinA treatment for patients with Complex Regional Pain Syndrome type I or II affecting one side of the body

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This study focuses on Complex Regional Pain Syndrome (CRPS), a chronic pain condition that typically affects one limb after an injury. The research examines a treatment using incobotulinumtoxinA (also known as Xeomin), which is a purified form of botulinum toxin. The medication will be administered through perineural injection, meaning it will be injected near the nerves in the affected area.

The purpose of this research is to determine if this treatment method is practical and safe for people with CRPS affecting either one arm or one leg. The study will involve participants receiving injections of Xeomin directly near the affected nerves. Each participant may receive up to 200 units of the medication, and the treatment period may last up to 12 months.

During the study, researchers will collect information about how participants respond to the treatment and any symptoms that occur after the injections. This information will help determine whether larger studies of this treatment should be conducted in the future. The study is designed as an open-label study, which means all participants will receive the active medication, and there will be no comparison group.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment with <b>Xeomin</b> injection

    You will receive an injection of Xeomin (200 units) near the affected nerves in your limb affected by Complex Regional Pain Syndrome

    The medication will be administered through perineural injection (injection near the nerves)

    Your current pain medication routine should remain unchanged during the study

  2. Step 2

    Post-injection monitoring

    Medical staff will monitor your condition after the injection

    Any symptoms or changes that occur after the injection will be documented

    You will be asked to report any flare-up symptoms that may occur following the treatment

  3. Step 3

    Follow-up assessment

    Your pain levels will be evaluated during follow-up visits

    You will participate in an interview about your experience with the treatment

    The medical team will assess how the treatment has affected your condition

  4. Step 4

    Study completion

    The study is expected to run from October 2025 to February 2026

    Throughout the study period, you must maintain your regular pain medication schedule

    Female participants must continue using approved contraception methods during the entire study period

Who can join the trial?

6 criteria

  • Must be 18 years of age or older
  • Must have Complex Regional Pain Syndrome (CRPS) type I or II affecting one upper or lower limb that: - Meets the Budapest Research Criteria (a standardized set of symptoms and signs used to diagnose CRPS) - Has been present for at least 6 months
  • The CRPS must be the main pain condition affecting the participant
  • Must have been on stable pain medication for at least one month before the study starts and agree to maintain the same medication throughout the study
  • Women who can become pregnant must agree to use effective contraception during the study period
  • Must be able to speak, read, and understand Danish

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 65 years
  • Pregnancy or breastfeeding
  • Previous allergic reactions to botulinum toxin (the active ingredient in Xeomin)
  • Active infection at the planned injection site
  • Presence of blood clotting disorders
  • Use of blood-thinning medications (anticoagulants)
  • History of neuromuscular junction disorders (conditions affecting nerve and muscle connections) such as myasthenia gravis
  • Current treatment with other botulinum toxin products
  • Major surgery in the affected area within the last 6 months
  • Participation in other clinical trials within the last 30 days
  • Severe psychiatric conditions that could interfere with the study
  • Inability to follow study procedures or attend follow-up visits
  • Presence of other chronic pain conditions that could affect study results
  • Use of medications that could interact with the study treatment
  • Unstable medical conditions that could affect safety during the study
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Investigated drugs

IncobotulinumtoxinA (Xeomin) is a purified form of botulinum toxin type A. It's used to block nerve signals that cause muscle contractions. In this trial, it is being studied as a treatment for Complex Regional Pain Syndrome (CRPS) by injecting it around specific nerves (perineural administration). This medication is already known for treating various conditions involving muscle spasms, but in this study, it's being investigated specifically for its potential to help patients with chronic pain conditions. The medication works by temporarily preventing nerve cells from releasing chemicals that transmit pain signals.

What is already known about the treatment

IncobotulinumtoxinA (Xeomin) - A highly purified botulinum neurotoxin type A formulation that is administered through perineural injection for treating Complex Regional Pain Syndrome (CRPS). This medication works by blocking the release of neurotransmitters at nerve endings, effectively reducing pain signals and muscle contractions in the affected area. As a neurotoxin-based therapeutic agent, it belongs to the class of neuromuscular blocking agents and is currently being investigated in clinical trials for its potential in managing CRPS types I and II. The medication is administered by healthcare professionals through carefully targeted injections near specific nerves, with its primary mechanism involving the inhibition of acetylcholine release at the neuromuscular junction.

Investigated diseases

Complex Regional Pain Syndrome - A chronic pain condition that typically affects one limb after an injury or trauma. The condition is characterized by continuous, intense pain that gets worse over time, along with changes in skin color, temperature, and swelling in the affected area. Patients may experience increased sensitivity to touch, abnormal sweating, changes in hair and nail growth, and reduced mobility in the affected limb. The condition can develop in two types: Type I occurs without a confirmed nerve injury, while Type II follows a distinct nerve injury. The pain is usually out of proportion to the initial injury that triggered the condition.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519832-17-00Estimated enrolment25 patientsSponsorRegion Hovedstaden

sourced from the EU Clinical Trials Register and site verification

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