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Neurotoxin
Botox for the Treatment of Recurrent Chronic Exertional Compartment Syndrome
Phase 4
Waitlist Available
Led By Michael Suer, MD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months, 4 months, 6 months
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group
Summary
This trial tests whether Botox injections can reduce pain in patients with R-CECS who still have pain after surgery. Botox works by stopping the muscles from contracting too much, which helps to lower pain and pressure.
Eligible Conditions
- Compartment Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 months, 4 months, 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months, 4 months, 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Pain Score
Incidence of Adverse Events
Number of Participants With Lower Extremity Weakness
Secondary study objectives
Change in Ability to Perform Activities of Daily Living
Change in Ankle Dorsiflexion Strength Using Kiio Force Sensor
Change in Ankle Eversion Strength Using Kiio Force Sensor
+9 moreSide effects data
From 2010 Phase 4 trial • 33 Patients • NCT001786468%
Foot pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Low Volume, High Dose
High Volume, High Dose
Low Volume, Low Dose
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Participants with R-CECSExperimental Treatment1 Intervention
Botox to be injected under standard palpatory technique into the affected lower leg compartment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Botox
2014
Completed Phase 4
~1180
Find a Location
Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,234 Previous Clinical Trials
3,200,290 Total Patients Enrolled
Michael Suer, MDPrincipal InvestigatorUniversity of Wisconsin, Madison
1 Previous Clinical Trials
7 Total Patients Enrolled