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:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT03821402
Eligibility Criteria:
Inclusion Criteria:
* 18 to 75 years of age
* Written informed consent including authorization to release health information
* Focal upper limb spasticity (ULS) after a stroke (as defined by WHO criteria) or traumatic brain injury (TBI), last stroke or TBI \> 24 weeks prior to Screening
* ULS with the primary aggregate posture
* Moderate to severe ULS with a MAS score ≥ 2 at the elbow, wrist, and finger flexors
* Moderate to severe functional disability (Disability Assessment Score \[DAS\] score ≥2) on the principal target of treatment
* Has sufficient cognitive and communication ability to be able to give informed consent
Exclusion Criteria:
* Upper limb spasticity attributable to an etiology other than stroke or TBI.
* Bilateral upper limb paresis or quadriplegia.
* Initiated in physiotherapy of the upper extremities ≤ 30 days prior to Screening or planned to start physiotherapy of the upper extremities during the course of the study.
* Previous or planned treatment of the spastic upper limb with phenol, alcohol injection, or surgery
* Profound muscular atrophy or fixed contracture leading to marked limitation on range of motion
* Prior treatment with intrathecal baclofen
* Any neuromuscular neurologic conditions (amyotrophic lateral sclerosis, Lambert- Eaton, myasthenia gravis)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03821402
Study Brief:
Protocol Section:
NCT03821402