Phase
Condition
N/ATreatment
Placebo
AbobotulinumtoxinA
Clinical Study ID
Ages 18-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Baseline Comparator Group:
Inclusion Criteria:
Adult male and female runners aged 18-65 years
Group providing normative values for SWE and needle manometry - ICP assessments
Exclusion
Exclusion Criteria:
- History of Neuromuscular disease, serious soft-tissue injury, fractures, and surgeryto the lower limb(s).
Treatment Groups:
Inclusion Criteria:
Confirmatory pressure values at diagnosis: Pre-exercise > 15 mmHg; 1-min. post > 30mmHg; or 5-min. post > 20mmHg
Ages 18-65 years inclusive at study onset.
Ability to adhere to protocol.
Botulinum toxin naïve (lower extremity). Others previously treated, > than 6 mos.before study entry.
Exclusion Criteria:
Diagnosis of comorbid pain conditions, including claudication and/or poplitealartery entrapment syndrome.
Serious soft tissue injury, fractures, or surgery in the lower limb(s) < than 12months before study entry.
Current need for surgery at any level of the lower extremity.
Treatment with any drug known to interfere with neuromuscular function (e.g.,aminoglycoside antibiotics or neuromuscular blocking agents).
Any other medical condition, laboratory, or diagnostic procedure finding that mightpreclude the administration of aboBoNTA (Dysport®).
Ongoing infection at the injection sites.
Diagnosed as either resistant or sensitive to botulinum toxin treatment of any typeor to any components of Dysport®
Cow milk protein allergy.
Vulnerable patient populations such as adults unable to consent, pregnant women,prisoners, persons who have not obtained the legal age for consent to treatment orprocedures
Study Design
Study Description
Connect with a study center
Emory Sports Medicine-Dunwoody
Atlanta, Georgia 30338
United StatesSite Not Available
Emory Hawks Sports Medicine Center
Brookhaven, Georgia 30329
United StatesSite Not Available
Emory Sports Medicine-Dunwoody
Atlanta 4180439, Georgia 4197000 30338
United StatesSite Not Available
Emory Hawks Sports Medicine Center
Brookhaven 4184530, Georgia 4197000 30329
United StatesSite Not Available
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