Botox for the Treatment of Recurrent Chronic Exertional Compartment Syndrome

NCT05006417 | Terminated Phase 4 Results FDA Drug

• 4 other identifiers: 2020-1375Protocol Version 8/4/2021A536120SMPH/ORTHO&REHAB/REHAB MED
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Compartment Syndrome of Leg

Outcome Measures

Primary Outcomes (3)

• Change in Pain Score

  Change in pain score (0-10, where 10 is increased pain) will be assessed at each time point will be assessed at each time point (2, 4, 6 months) using Friedman's ANOVA.

  2 months, 4 months, 6 months

• Number of Participants With Lower Extremity Weakness

  A primary safety endpoint is incidence of lower extremity weakness, measured by

  up to 6 months

• Incidence of Adverse Events

  A primary safety endpoint is the incidence of adverse events, such as bruising, bleeding, pain, redness, or swelling where the injection was given.

  one study visit (within 2 hours)

Secondary Outcomes (12)

• Change in Ankle Dorsiflexion Strength Using Kiio Force Sensor

  baseline and month 2

• Change in Ankle Plantarflexion Strength Using Kiio Force Sensor

  baseline and month 2

• Change in Ankle Inversion Strength Using Kiio Force Sensor

  baseline and month 2

• Change in Ankle Eversion Strength Using Kiio Force Sensor

  baseline and month 2

• Change in Ability to Perform Activities of Daily Living

  baseline, 2 months, 4 months, 6 months

Study Arms (1)

Participants with R-CECS

EXPERIMENTAL

Botox to be injected under standard palpatory technique into the affected lower leg compartment.

Drug: Botox

Interventions

Botox DRUG

reconstituted at 100 units/mL, dosage will be based upon the affected muscles

Also known as: OnabotulinumtoxinA

Participants with R-CECS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Michael Suer, MD
• Organization: UW School of Medicine and Public Health

suer@rehab.wisc.edu

(608) 265-3207

Study Officials

• Michael Suer, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 16, 2021
• Study Start: November 23, 2022
• Primary Completion: November 23, 2022
• Study Completion: November 23, 2022
• Last Updated: July 18, 2024
• Results First Posted: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)