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:
2025-12-24 @ 2:04 PM
Ignite Modification Date:
2025-12-24 @ 2:04 PM
NCT ID:
NCT00945295
Eligibility Criteria:
Inclusion Criteria:
* Adults 18 years of age or older
* Stroke (ischemic or hemorrhagic) diagnosed by a neurologist at least 6 months prior to enrollment
* Focal spasticity in upper limb measured at the elbow, wrist, fingers and thumb with a Modified Ashworth Scale (MAS) of 3 or greater in the wrist and/or fingers
* Functional impairment secondary to spasticity such as difficulty with hygiene, dressing, posture or pain
* Minimum weight of 44 kg (88 lbs) in order to tolerate the minimum required dosage of 200 U
* Written informed consent has been obtained
* Written authorization for Use and Release of Health and Research Study Information has been obtained
* Laboratory findings required (if applicable)
* Ability to follow study instructions and likely to complete all required visits
* Negative urine pregnancy test on the day of treatment prior to the administration of study medication (for females of childbearing potential). (If applicable.)
Exclusion Criteria:
* Uncontrolled clinically significant medical condition other than the condition under evaluation
* Known allergy or sensitivity to any of the components in the study medication
* Females who are pregnant, breast-feeding, or planning a pregnancy during the study or who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study
* Concurrent participation in another investigational drug or device study or participation in the 30 days immediately prior to study enrollment
* Fixed contracture or profound atrophy in the spastic limb
* Prior or current treatment with neurolytic agents such as phenol or surgery; any version of botulinum toxin (other than BoNT-A more than 6 months prior to enrollment)
* Current rehabilitation therapy that cannot be altered to the treatment plan in the study
* Unable or unwilling to participate in a weekly rehab program
* Any medical condition that may put the subject at increased risk with exposure to BOTOX including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function
* Current treatment with agents affecting neuromuscular transmission
* Evidence of recent alcohol or drug abuse
* Infection or skin disorder at an anticipated injection site (if applicable)
* Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00945295
Study Brief:
Protocol Section:
NCT00945295