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Study on Fremanezumab for Pain Relief in Patients with Complex Regional Pain Syndrome

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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 effects of a medication called fremanezumab on pain experienced by patients with Complex Regional Pain Syndrome (CRPS). CRPS is a condition that causes severe, long-lasting pain, often affecting a limb after an injury. The study aims to compare the change in pain levels in patients receiving fremanezumab to those receiving a placebo. Fremanezumab is administered as a solution for injection in a pre-filled syringe.

Participants in the study will receive either fremanezumab or a placebo over a period of eight weeks. The study will monitor changes in pain intensity from the beginning to the end of the treatment period. Pain levels will be assessed using a numeric scale, where patients rate their pain from 0 (no pain) to 10 (worst possible pain). The study will also evaluate other aspects of CRPS, such as pain relief and the severity of symptoms, to understand the overall impact of fremanezumab on the condition.

In addition to fremanezumab, the study involves the use of sodium chloride as a solution for infusion. This is a common substance used in medical treatments to help maintain fluid balance in the body. The trial is designed to provide insights into how fremanezumab can potentially help manage pain in CRPS patients, offering a new avenue for treatment in this challenging condition.

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 trial

    Upon joining the trial, you will be asked to provide written informed consent. This means you agree to participate after understanding the trial's purpose and procedures.

    You must meet certain criteria, such as being between 18 and 75 years old, having a confirmed diagnosis of Complex Regional Pain Syndrome (CRPS) according to specific guidelines, and experiencing the condition for 3 to 18 months.

  2. Step 2

    Baseline assessment

    During the baseline week, your average daily pain intensity (ADP) will be measured using a numeric rating scale from 0 to 10, where 0 means no pain and 10 means the worst pain imaginable.

    This assessment helps establish a starting point for comparing changes in pain intensity throughout the trial.

  3. Step 3

    Treatment phase

    You will receive either the active treatment, fremanezumab, or a placebo. Fremanezumab is administered as a solution for injection using a pre-filled syringe.

    The injection is given subcutaneously, which means it is injected under the skin. The dosage is 225 mg, and the frequency and duration will be specified by the trial team.

  4. Step 4

    Ongoing assessments

    Throughout the trial, you will be asked to report your daily pain levels using the same numeric rating scale. This helps track changes in pain intensity over time.

    Additional assessments may include evaluating pain relief on a 6-point scale and measuring changes in CRPS severity.

  5. Step 5

    Final assessment

    At the end of the treatment period, a final assessment will be conducted to compare your pain levels from the baseline to the last week of treatment.

    The trial aims to determine the difference in pain intensity between those receiving fremanezumab and those receiving a placebo.

Who can join the trial?

5 criteria

  • Age between 18 and 75 years.
  • Confirmed Complex Regional Pain Syndrome (CRPS) diagnosed according to the International Association of Pain (IASP) diagnostic criteria, known as the Budapest criteria.
  • The disease has lasted from 3 to 18 months.
  • A mean Average Daily Pain (ADP) score of at least 4 on an 11-point Numerical Rating Scale (NRS) ranging from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable, during the baseline week.
  • Written informed consent is required.

Who cannot join the trial?

8 criteria

  • Patients who have a medical condition other than Complex Regional Pain Syndrome (CRPS) cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, such as those who cannot give consent, cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients who have a history of allergic reactions to the study medication or similar medications cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with certain medical conditions that might interfere with the study results cannot participate.
  • Patients who have used certain medications recently that might interfere with the study cannot participate.
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Investigated drugs

Fremanezumab is a medication used in this clinical trial to help reduce pain in patients with Complex Regional Pain Syndrome (CRPS). It works by blocking a specific protein in the body that is involved in the transmission of pain signals. By doing this, fremanezumab aims to decrease the intensity of pain experienced by patients. This trial is designed to see how effective fremanezumab is in reducing pain compared to a placebo, which is a substance with no active medication. The goal is to find out if fremanezumab can provide significant pain relief for people suffering from CRPS.

What is already known about the treatment

Fremanezumab – Fremanezumab is administered as an injection under the skin and is currently being studied for its effects on pain in patients with Complex Regional Pain Syndrome (CRPS). It is in the clinical trial phase, where researchers are evaluating its effectiveness compared to a placebo. The main therapeutic use being explored is the reduction of pain intensity in CRPS patients. At the molecular level, fremanezumab works by targeting and blocking a protein involved in pain signaling, which may help reduce pain. It is classified as a monoclonal antibody, a type of medication designed to target specific proteins in the body.

Investigated diseases

Complex Regional Pain Syndrome – Complex Regional Pain Syndrome is a chronic pain condition that typically affects one limb, often after an injury. It is characterized by prolonged or excessive pain and changes in skin color, temperature, and swelling in the affected area. The pain is often described as burning or throbbing and may be accompanied by increased sensitivity to touch or cold. Over time, the affected limb may experience changes in skin texture, abnormal sweating patterns, and decreased mobility. The condition can progress to include muscle spasms, tremors, and weakness. In some cases, the symptoms may spread to other parts of the body.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-503167-15-00Estimated enrolment60 patientsSponsorRegion Midtjylland

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