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 @ 4:17 PM
Ignite Modification Date:
2025-12-24 @ 4:17 PM
NCT ID:
NCT00432666
Eligibility Criteria:
Main Inclusion Criteria:
* Female or male patients ≥ 18 years
* ≥ 6 months since the last stroke, diagnosed by an appropriate health care professional (e.g., neurologist)
* Focal spasticity with ≥ 2 points on the Ashworth Scale in the wrist flexors with clinical pattern Flexed Wrist
* Focal spasticity with ≥ 2 points on the Ashworth Scale in the fingers flexors with clinical pattern Clenched Fist
* For pre-treated patients only: source documentation of the most recent injection session with Botulinum Toxin and sufficient therapeutic response for Flexed Wrist and Clenched Fist
* For pre-treated patients only: the most recent injection with Botulinum Toxin must have been maximal 50 Units BOTOX® or 200 Units Dysport® or 2000 Units Neurobloc® (type B preparation) per each of these flexors: carpi ulnaris, digitorum superficialis, digitorum profundus
* For pre-treated patients only: the most recent injection with Botulinum Toxin must have been maximal 60 Units BOTOX® or 240 Units Dysport® or 2400 Units Neurobloc® (type B preparation) for flexor carpi radialis
Main Exclusion Criteria:
* Spasticity of any other origin than stroke
* Previous treatment with Botulinum Toxin of any serotype and for any body region within the 4 months prior to Screening (Visit 1, Day -7)
* Planned concomitant treatment with Botulinum Toxin of any serotype and for any body region
* Previous or planned treatment with phenol- or alcohol-injection in the target limb
* Previous surgical treatment of spasticity in the target muscle(s)
* Fixed contracture, defined as severe restriction of the range of joint movement on passive stretch
* Severe atrophy of the target limb muscles
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00432666
Study Brief:
Protocol Section:
NCT00432666