Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-26 @ 11:14 AM
NCT ID:
NCT01603628
Eligibility Criteria:
Inclusion Criteria:
* Minimum weight of 10 kg/22 lb
* Cerebral palsy with dynamic muscle contracture /spasticity of the ankle
Exclusion Criteria:
* Muscular dystrophy, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or mitochondrial disease
* Uncontrolled epilepsy
* Botulinum Toxin therapy of any serotype for any condition within the last 6 months
* History of surgical intervention of the lower study leg or planned surgery of any limb during the study
* Previous casting of the study limb for spasticity within 6 months or with a dynamic splint within 3 months, or planned casting or dynamic splinting for spasticity of the study limb or affected upper limb during the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
16 Years
Study:
NCT01603628
Study Brief:
Protocol Section:
NCT01603628