Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Non-Surgical Treatment Options for CECS
NCT04409600Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2020
- Primary completion
- Dec 2024
- Countries
- 1
- Sponsor
- Walter Reed National Military Medical Center
- Modality
- Recombinant Proteins and Enzymes
- Drugs
- neuronox
- Conditions
- Chronic Exertional Compartment Syndrome (CECS)
01
Overview
Phase 2, randomised trial of neuronox in Chronic Exertional Compartment Syndrome (CECS) (4 arms), sponsored by Walter Reed National Military Medical Center. Primary endpoints: University of Wisconsin Running Injury and Recovery Index at 24 months, Single Assessment Numerical Evaluation at 24 months and 6 more. Started Nov 2020; status: completed.
02
Design
4 arms- Study design
- Randomized
Home Based Gait Retraining + Saline Injection
1 clinic session for home-based gait retraining program + saline injection.
Home Based Gait Retraining + Botulinum Toxin Injection
1 clinic session for home-based gait retraining program + botulinum toxin injection.
Supervised Gait Retraining + Saline Injection
8 clinic sessions over 6 weeks for supervised gait retraining + saline injection.
Supervised Gait Retraining + Botulinum Toxin Injection
8 clinic sessions over 6 weeks for supervised gait retraining + botulinum toxin injection.
03
Who it enrols
Active duty service members fluent in English with a clinical diagnosis of CECS of the anterior or lateral compartment, unable to run 2 miles without pain, and no prior botulinum injection or compartment release in the affected leg.
04
Endpoints
Primary
University of Wisconsin Running Injury and Recovery Index
Single Assessment Numerical Evaluation
Global Rate of Change
Duty Status
Patient Specific Functional Scale
Secondary
Ability to Perform Service Specific Job Tasks
Pain Running 2 Miles
Patient Satisfaction of Treatment
Beyond the preview
Go deeper on NCT04409600.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT04409600.