BridgeMD
New treatment option for CRPS (Complex Regional Pain Syndromes)
Official title Perineural Incobotulinumtoxin-A for Complex Regional Pain Syndrome - An Open-label Feasibility Study
ClinicalTrials.gov ID: NCT07473635
What this study is testing
What is Perineural Incobotulinumtoxin-A 200 U?
Perineural Incobotulinumtoxin-A 200 U is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for crps (complex regional pain syndromes).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Complex Regional Pain Syndrome (CRPS) is a chronic pain condition characterized by severe regional pain, sensory disturbances, and functional impairment. Current treatment options are limited, and many patients experience substantial pain-related disability and symptom fluctuations, including flare-ups triggered by invasive procedures.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Are over the age of 18
- Have a diagnosis of CRPS type 1 or 2 in either one upper or one lower extremity which fulfils the Budapest research criteria
- Have had the condition for at least 6 months
- Rate CRPS as their primary pain condition
- Have been on a stable analgesic regimen, including any rescue medications, for at least 1 month prior to the study and intend to maintain this...
You likely can't join if
- Are allergic to botulinum toxin A
- Have been treated with botulinum toxin A for any indication within 3 months prior to study start
- Are diagnosed with myasthenia, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other condition which makes differentiation of...
- Have an ongoing infection in the affected limb
- Do not intend to start physical therapy, psychotherapy, or any other non-pharmaceutical intervention aimed at reducing pain
- Have used a topical analgesic treatment such as lidocaine patches within 1 week prior to study start or have been treated with capsaicin patches in...
See the full eligibility criteria
- Are over the age of 18
- Have a diagnosis of CRPS type 1 or 2 in either one upper or one lower extremity which fulfils the Budapest research criteria
- Have had the condition for at least 6 months
- Rate CRPS as their primary pain condition
- Have been on a stable analgesic regimen, including any rescue medications, for at least 1 month prior to the study and intend to maintain this regimen throughout the study
- For pre-menopausal females: are using a safe and approved contraceptive
- Speak, read, and understand Danish
- Are allergic to botulinum toxin A
- Have been treated with botulinum toxin A for any indication within 3 months prior to study start
- Are diagnosed with myasthenia, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other condition which makes differentiation of CRPS-specific pain difficult
- Have an ongoing infection in the affected limb
- Do not intend to start physical therapy, psychotherapy, or any other non-pharmaceutical intervention aimed at reducing pain
- Have used a topical analgesic treatment such as lidocaine patches within 1 week prior to study start or have been treated with capsaicin patches in the affected area within 3 months prior to study start
- Have psychiatric comorbidities which are considered by the investigators to impact their ability to participate
- Consume alcohol in excess of what is recommended by the Danish Health Ministry
- Are active abusers of illicit narcotics
- Are pregnant, lactating, or plan on becoming pregnant during the study period
- Have any other condition or circumstance that, in the investigators' opinion, will hinder safe and timely participation and completion of the study
The study team makes the final eligibility decision.
Where it's taking place
- Glostrup, Region Sjælland, Denmark
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Glostrup, Region Sjælland, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.