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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Region Midtjylland	Aarhus	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.08.2023

Trial locations

Investigated drugs:

Fremanezumab

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.

Investigated diseases:

Complex regional pain syndrome

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 ID:

2022-503167-15-00

Trial Phase:

Therapeutic exploratory (Phase II)

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

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