OnabotulinumtoxinA (Botox) Effect on Pain and Function in Recurrent Chronic Exertional Compartment Syndrome: a Pilot Study

2020-1375

10 participants with Recurrent Chronic Exertional Compartment Syndrome (R-CECS) will be enrolled in a 6 month study at the University of Wisconsin Hospitals and Clinics to test the hypothesis that injection of Botox into the affected muscle group will alleviate pain associated with R-CECS.

2022-11-23

2022-11-23

2022-11-23

Terminated

Early phase I

1

Inclusion Criteria: * Willing to provide written informed consent * Willing to comply with all study procedures and be available for the duration of the study * Documented diagnosis of R-CECS determined with elevated compartmental pressure testing following lower extremity fascia release (fasciotomy or fasciectomy) * Females of childbearing potential must have a negative urine pregnancy test prior to enrollment and agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to randomization, for the duration of study participation, and for 7 days following completion of therapy. * A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy; or * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). Exclusion Criteria: * History of hypersensitivity or allergy to any of the study drugs or drugs of similar chemical classes * Known neuromuscular disease * Known pulmonary disease including but not limited to asthma, pneumonia, or upper respiratory tract infection * Dysphagia * Known cardiac disease including but not limited to congestive heart failure, arrhythmia, or history of myocardial infarction * Enrolled in another clinical trial or has used of any investigational drugs, biologics, or devices within 30 days prior to enrollment * Currently or have taken in the past medications that affect neuromuscular function, aminoglycosides, muscle relaxants, or other botulinum neurotoxin agents. Currently taking any blood-thinning medications including, but not limited to Plavix, Coumadin, Eliquis, Xarelto * Women who are pregnant or breast-feeding * Vulnerable populations * Not suitable for study participation due to other reasons at the discretion of the investigator

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 1, 'type': 'ACTUAL'}}

2024-05-16