N/A
N=108
Observational Study of Botox® Treatment for Patients With Upper Limb Adult Spasticity
Muscle Spasticity
Bottom Line
View on ClinicalTrials.gov: NCT01387074 ↗Enrolled (actual)
108
Serious AEs
0.9%
Results posted
Feb 2014
Primary outcome: Primary: Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Baseline — 2; 6; 18; 39 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- botulinum toxin Type A (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Baseline |
2; 6; 18; 39; 30; 6 | — |
| PRIMARY Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Week 24 |
2; 26; 43; 12; 5; 1 | — |
| PRIMARY Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Baseline |
3; 9; 16; 29; 35; 9 | — |
| PRIMARY Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Week 24 |
5; 31; 31; 15; 6; 1 | — |
| PRIMARY Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Baseline |
0; 5; 15; 20; 47; 14 | — |
| PRIMARY Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Week 24 |
4; 34; 27; 17; 5; 2 | — |
| PRIMARY Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Baseline |
1; 13; 19; 19; 36; 13 | — |
| PRIMARY Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Week 24 |
19; 29; 18; 11; 11; 1 | — |
Summary
This is a prospective, non-interventional, observational study to collect data on the use of botulinum toxin Type A in a routine setting in patients with upper limb adult spasticity.
Eligibility Criteria
Inclusion Criteria
- Adult patients with upper limb spasticity following a stroke
- Eligible to receive botulinum toxin Type A
- No previous botulinum toxin Type A therapy
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT01387074). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.