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Clinical Trials in the EU / 2025-524042-99-00
Authorised, not yet recruiting Phase III

Optimizing treatment for chronic exertional compartment syndrome of the lower extremities: the Botox study, a double-blind randomized placebo controlled trial.

2025-524042-99-00 · tracked via the Priya Life Science EU tracker
Sponsor
Universitair Medisch Centrum Utrecht
Sponsor type
Hospital/Clinic/Other health care facility
Therapeutic area
Musculoskeletal Diseases
Decision date
15/10/2026
Enrollment target
108
Sites
Netherlands

Condition studied

Chronic exertional compartment syndrome (CECS) of the leg

Investigational medicinal product(s)

Sodium Chloride 0.9%Solution for InjectionBOTULINUM TOXIN TYPE A

Every trial of Botulinum toxin type A across our registers →

Eligibility

Age group
0-17 years, 18-64 years
Sex
Female, Male

Primary endpoint

Primary outcome measure is a patient reported functioning based on Single Assessment Numeric Evaluation (SANE) score in patients receiving BoNT-A injections compared to placebo using multilevel evaluation.

Endpoint detail

Secondary outcome is the number of prevented surgical interventions in patients with ant-CECS in patients receiving BoNT-A injection compared to placebo.

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-524042-99-00 on CTIS ↗ ← All trials in the EU