Fremanezumab for pain in Complex Regional Pain Syndrome
EU CTIS ID: 2022-503167-15-00
What this study is testing
The main objective is to compare the change in pain intensity from baseline to last week of fremanezumab treatment to placebo treatment in patients with CRPS.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age between 18 and 75 years.
- Confirmed CRPS (type I or II) diagnosed according to the International Association of Pain (IASP) diagnostic criteria of CRPS (Budapest criteria) with adaption to research
- Disease lasting from 3-36 months
- Mean ADP score of at least 4 on a 11-point NRS scale ranging from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable during the baseline week
- Written informed consent.
You likely can't join if
- Other causes of pain and/or inflammation in the same area as CRPS or other concomitant pain/inflammation that cannot be distinguished from CRPS.
- Significant severe disease
- Spreading of the CRPS to other extremities according to IASP criteria for spreading of CRPS
- Initiation of new pain medication or corticosteroids.
- Poor compliance or patients who cannot cooperate or are unable to be able to complete the project and language difficulties.
- Severe depression or other significant psychiatric disease, alcohol or drug abuse.
See the full eligibility criteria
- Age between 18 and 75 years.
- Confirmed CRPS (type I or II) diagnosed according to the International Association of Pain (IASP) diagnostic criteria of CRPS (Budapest criteria) with adaption to research
- Disease lasting from 3-36 months
- Mean ADP score of at least 4 on a 11-point NRS scale ranging from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable during the baseline week
- Written informed consent.
- Other causes of pain and/or inflammation in the same area as CRPS or other concomitant pain/inflammation that cannot be distinguished from CRPS.
- Significant severe disease
- Spreading of the CRPS to other extremities according to IASP criteria for spreading of CRPS
- Initiation of new pain medication or corticosteroids.
- Poor compliance or patients who cannot cooperate or are unable to be able to complete the project and language difficulties.
- Severe depression or other significant psychiatric disease, alcohol or drug abuse.
- Pregnancy or lactation.
- Women of child-bearing potential unless they use an acceptable effective contraception measure during the study and at least 6 months after or their male partner is vasectomized and their sole partner.
- Known allergy to any component of fremanezumab.
- Planned surgery.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.