Phase 3
N=317
Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Arm After a Stroke
Post-stroke Spasticity of the Upper Limb
Bottom Line
View on ClinicalTrials.gov: NCT01392300 ↗Enrolled (actual)
317
Serious AEs
5.1%
Results posted
Feb 2016
Primary outcome: Primary: Change From Baseline in Ashworth Scale (AS) Score of Primary Target Clinical Pattern — -0.9; -0.5 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- IncobotulinumtoxinA (400 Units) (Drug); Placebo Comparator (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merz Pharmaceuticals GmbH
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Ashworth Scale (AS) Score of Primary Target Clinical Pattern |
-0.9; -0.5 | <0.001 sig |
| PRIMARY Investigator's Global Impression of Change |
1.2; 0.9 | 0.003 sig |
| SECONDARY Response Rates on the Ashworth Scale at Week 4 Calculated for the Primary Target Clinical Pattern |
119; 33 | <0.001 sig |
| SECONDARY Response Rates on the Ashworth Scale at Week 8 Calculated for the Primary Target Clinical Pattern |
104; 34 | <0.001 sig |
| SECONDARY Response Rates on the Ashworth Scale at Week 12 Calculated for the Primary Target Clinical Pattern |
68; 22 | 0.004 sig |
| SECONDARY Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Wrist |
102; 31 | <0.001 sig |
| SECONDARY Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Wrist |
90; 33 | 0.021 sig |
| SECONDARY Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Wrist |
59; 17 | 0.006 sig |
| SECONDARY Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Elbow |
99; 28 | <0.001 sig |
| SECONDARY Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Elbow |
85; 28 | 0.002 sig |
| SECONDARY Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Elbow |
52; 21 | 0.102 |
| SECONDARY Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Clenched Fist |
90; 26 | <0.001 sig |
| SECONDARY Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Clenched Fist |
82; 27 | 0.002 sig |
| SECONDARY Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Clenched Fist |
49; 19 | 0.069 |
| SECONDARY Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Thumb-in-palm |
56; 21 | 0.034 sig |
| SECONDARY Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Thumb-in-palm |
52; 23 | 0.169 |
| SECONDARY Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Thumb-in-palm |
35; 20 | 0.920 |
| SECONDARY Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Pronated Forearm |
73; 19 | <0.001 sig |
| SECONDARY Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Pronated Forearm |
64; 20 | 0.007 sig |
| SECONDARY Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Pronated Forearm |
51; 15 | 0.018 sig |
| SECONDARY Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist. |
-0.8; -0.5 | <0.001 sig |
| SECONDARY Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist. |
-0.6; -0.4 | 0.011 sig |
| SECONDARY Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist. |
-0.3; -0.1 | 0.032 sig |
| SECONDARY Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow. |
-0.7; -0.3 | <0.001 sig |
| SECONDARY Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow. |
-0.6; -0.3 | <0.001 sig |
| SECONDARY Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow. |
-0.4; -0.2 | 0.029 sig |
| SECONDARY Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Clenched Fist. |
-0.7; -0.3 | <0.001 sig |
| SECONDARY Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Clenched Fist. |
-0.6; -0.4 | 0.019 sig |
| SECONDARY Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Clenched Fist. |
-0.3; -0.1 | 0.137 |
| SECONDARY Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm. |
-0.4; -0.2 | 0.013 sig |
| SECONDARY Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm. |
-0.3; -0.2 | 0.131 |
| SECONDARY Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm. |
-0.2; -0.1 | 0.714 |
| SECONDARY Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm. |
-0.5; -0.2 | <0.001 sig |
| SECONDARY Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm. |
-0.4; -0.2 | 0.008 sig |
| SECONDARY Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm. |
-0.3; -0.1 | 0.062 |
| SECONDARY Changes From Baseline to Week 4 in Disability Assessment Scale - Principal Therapeutic Target Domain |
-0.5; -0.3 | 0.006 sig |
| SECONDARY Changes From Baseline to Week 8 in Disability Assessment Scale - Principal Therapeutic Target Domain |
-0.5; -0.3 | 0.076 |
| SECONDARY Changes From Baseline to Week 12 in Disability Assessment Scale - Principal Therapeutic Target Domain |
-0.4; -0.4 | 0.416 |
| SECONDARY Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Hygiene |
-0.4; -0.1 | <0.001 sig |
| SECONDARY Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Hygiene |
-0.4; -0.2 | 0.175 |
| SECONDARY Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Hygiene |
-0.3; -0.1 | 0.140 |
| SECONDARY Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Dressing |
-0.4; -0.2 | 0.007 sig |
| SECONDARY Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Dressing |
-0.4; -0.2 | 0.018 sig |
| SECONDARY Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Dressing |
-0.3; -0.1 | 0.105 |
| SECONDARY Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Limb Position |
-0.5; -0.3 | 0.016 sig |
| SECONDARY Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Limb Position |
-0.4; -0.2 | 0.014 sig |
| SECONDARY Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Limb Position |
-0.4; -0.3 | 0.220 |
| SECONDARY Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Pain |
-0.2; -0.2 | 0.429 |
| SECONDARY Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Pain |
-0.2; -0.2 | 0.884 |
| SECONDARY Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Pain |
-0.3; -0.2 | 0.844 |
Summary
The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the upper limb are effective in treating spasticity in patients after stroke.
Eligibility Criteria
Inclusion Criteria
- Upper limb spasticity
- Time since stroke greater than 3 months
- Need for 400 U Botulinum toxin type A
Exclusion Criteria
- Body weight below 50kg
- Fixed contractures of the upper limb
- Generalized disorders of muscle activity like Myasthenia gravis that preclude use of Botulinum toxin Type A
- Infection at the injection site
Data sourced from ClinicalTrials.gov (NCT01392300). 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.