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Perineural incobotulinumtoxin-A for Complex Regional Pain Syndrome - An open-label feasibility study (PINCom)
EU CTIS ID: 2024-519832-17-00
What this study is testing
To evaluate the feasibility and safety of perineural administration of incobotulinumtoxinA (Xeomin) in patients with unilateral CRPS type I or II, in preparation for a future controlled efficacy trial.
- 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
- Participant is 18 years of age or older.
- Participant has a diagnosis of CRPS type I or II affecting one upper or one lower limb which 1) meets the Budapest Research Criteria and 2) has been present for at least 6 months
- CRPS is rated by the participant as their primary pain condition.
- Analgesic treatment, including rescue medications, has been stable for at least one month prior to study entry and will be maintained throughout the study.
- Female participants of childbearing potential agree to use an effective and approved method of contraception during the study period.
- Participant can speak, read, and understand Danish.
You likely can't join if
- Participant has a known allergy to incobotulinumtoxinA (BoNT-A).
- Participant is actively using illicit drugs.
- Participant is pregnant, breastfeeding, or planning pregnancy during the study period.
- Participant has any other condition or circumstance that the investigator considers incompatible with safe and complete study participation.
- Participant has received any BoNT-A treatment within 3 months prior to study start.
- Participant has a diagnosis of myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or other conditions that impair accurate pain assessment.
See the full eligibility criteria
- Participant is 18 years of age or older.
- Participant has a diagnosis of CRPS type I or II affecting one upper or one lower limb which 1) meets the Budapest Research Criteria and 2) has been present for at least 6 months
- CRPS is rated by the participant as their primary pain condition.
- Analgesic treatment, including rescue medications, has been stable for at least one month prior to study entry and will be maintained throughout the study.
- Female participants of childbearing potential agree to use an effective and approved method of contraception during the study period.
- Participant can speak, read, and understand Danish.
- Participant has a known allergy to incobotulinumtoxinA (BoNT-A).
- Participant is actively using illicit drugs.
- Participant is pregnant, breastfeeding, or planning pregnancy during the study period.
- Participant has any other condition or circumstance that the investigator considers incompatible with safe and complete study participation.
- Participant has received any BoNT-A treatment within 3 months prior to study start.
- Participant has a diagnosis of myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or other conditions that impair accurate pain assessment.
- Participant has an active infection in the affected limb.
- Participant plans to initiate physical therapy, psychotherapy, or other non-pharmaceutical pain treatments during the study.
- Participant has used topical analgesics (e.g. lidocaine patches) on the affected area within 1 week of study start.
- Participant has been treated with capsaicin patches on the affected area within 3 months of study start.
- Participant has psychiatric comorbidities that, in the investigator’s opinion, may interfere with participation.
- Participant consumes alcohol above the recommended limits set by the Danish Health Authority.
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, 65+ years, 18-64 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.