Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07473635
Eligibility Criteria:
Inclusion 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
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07473635
Study Brief:
Protocol Section:
NCT07473635