Botox for the Treatment of Chronic Exertional Compartment Syndrome

NCT03922139 | Terminated Phase 1 Results FDA Drug

• 5 other identifiers: 2017-1061Ortho RehabProtocol Version 6/15/2020A536760SMPH\PEDIATRICS\GPAM
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

After diagnosis of Chronic Exertional Compartment Syndrome (CECS), the participants will be referred to both physical therapy and Botox injection. In physical therapy, the therapist will perform strength measurements of the lower leg (ankle plantarflexion and dorsiflexion) which will be repeated 2 months following the injection. An ultrasound-guided injection of 50 units of Botox will be administered into the tibialis anterior. 25 units will be injected into two different spots in the muscle one being more proximal and the other distal. This will be a one-time injection and will be observed as to how it effects participant symptoms over the next 6 months at either a clinic visit (at 2 months) or telephone call (at 4 and 6 months after injection) via the University of Wisconsin Running Index. Two months following the injection, the participant will undergo repeat measurements of strength using the Kiio Force Sensor. Should potential participants of childbearing potential wish to enroll in the study, a urine pregnancy test will be performed prior to enrollment; participants will not be enrolled if test is positive.

Conditions

Compartment Syndrome of Leg

Outcome Measures

Primary Outcomes (3)

• Percentage of Relief of Pain

  Percentage of Relief of Pain will be assessed at each time point (2,4,6 months) using Friedman's ANOVA.

  Baseline, 2 months, 4 months and 6 months

• Number of Participants With Lower Extremity Weakness

  A primary safety endpoint is the incidence of lower extremity weakness

  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.

  up to 6 months

Secondary Outcomes (12)

• Change in Ankle Dorisflexsion 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)

Botox

EXPERIMENTAL

Ultrasound guided 1 mg/1 mL injection. 25 units of Botox will be injected 2 cm proximal and 2 cm distal to the midpoint of the tibialis anterior muscle.

Drug: OnabotulinumtoxinA Injection

Interventions

OnabotulinumtoxinA Injection DRUG

Ultrasound guided 1 mg/1 mL injection. 25 units of Botox will be injected 2 cm proximal and 2 cm distal to the midpoint of the tibialis anterior muscle.

Also known as: Botox

Botox

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 including reliable use of telephone for communication
• Male or female, at least 18 years of age
• Documented diagnosis of CECS
• 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 enrollment and for the duration of study participation. 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).
• Be involved, either competitively or non-competitively, in an activity requiring significant running as determined by the PI

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
• History of lower extremity fasciotomy
• Enrolled in another clinical trial or has used 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
• 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)

Pain Management Clinic

Madison, Wisconsin, 53715, 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

  UW Madison - SMPH, Department of Orthopedics and Rehabilitation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 19, 2019
• Study Start: October 8, 2019
• Primary Completion: December 15, 2021
• Study Completion: December 15, 2021
• Last Updated: February 14, 2023
• Results First Posted: February 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)