Phase 3
N=155
Efficacy and Safety Dose Titration Study of Botulinum Toxin Type A to Treat Spasticity in the Leg and Arm
Spasticity of the Upper and Lower Limb Due to Cerebral Causes
Bottom Line
View on ClinicalTrials.gov: NCT01603459 ↗Enrolled (actual)
155
Serious AEs
11.0%
Results posted
Feb 2017
Primary outcome: Primary: Occurrence of Treatment-Emergent Adverse Events (AEs), AEs of Special Interest (AESIs), and Serious AEs (SAEs) by Injection Cycle, Overall and Related to the Administration of Study Medication — 56; 57; 36; 7 subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- IncobotulinumtoxinA (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merz Pharmaceuticals GmbH
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Occurrence of Treatment-Emergent Adverse Events (AEs), AEs of Special Interest (AESIs), and Serious AEs (SAEs) by Injection Cycle, Overall and Related to the Administration of Study Medication |
56; 57; 36; 7; 8; 4 | — |
| PRIMARY Investigator's Global Assessment of Tolerability in Subjects |
121; 111; 117; 29; 26; 20 | — |
| SECONDARY Ashworth Scale (AS) Scores of the Target Joint Selected at Study Baseline Visit |
3.0; 2.1; 2.7; 2.0; 2.6; 1.7 | — |
| SECONDARY Change of Ashworth Scale (AS) Score of the Target Joint Selected at Study Baseline Visit From Injection Cycle Baseline Visits to Respective Control Visits |
-0.8; -0.8; -0.9 | — |
| SECONDARY Change of Ashworth Scale (AS) Score of the Target Joint Selected at Study Baseline Visit From Study Baseline Visit to Control Visits of Injection Cycles |
-0.8; -1.0; -1.3 | — |
| SECONDARY Change of Ashworth Scale (AS) Score of the Target Joint Selected at Study Baseline Visit From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit |
-0.2; -0.3; -0.7 | — |
| SECONDARY Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity |
2.7; 2.2; 2.5; 2.0; 2.5; 1.9 | — |
| SECONDARY Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits |
-0.5; -0.6; -0.5; -0.7; -0.7; -0.9 | — |
| SECONDARY Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles |
-0.5; -0.6; -0.5; -0.7; -0.9; -1.2 | — |
| SECONDARY Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit |
-0.0; 0.0; -0.3; -0.2; -0.3; -0.8 | — |
| SECONDARY Resistance to Passive Movement Scale (REPAS) Scores of Treated Side |
24.8; 20.2; 24.0; 18.1; 22.9; 15.7 | — |
| SECONDARY Change of Resistance to Passive Movement Scale (REPAS) Score of Treated Side From Injection Cycle Baseline Visits to Respective Control Visits |
-4.6; -5.9; -7.1 | — |
| SECONDARY Change of Resistance to Passive Movement Scale (REPAS) Score of Treated Side From Study Baseline Visit to Control Visits of Injection Cycles |
-4.6; -6.7; -9.0 | — |
| SECONDARY Change of Resistance to Passive Movement Scale (REPAS) Score of Treated Side From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit |
-0.8; -1.9; -5.5 | — |
| SECONDARY Functional Ambulation Classification (FAC) Scale Scores |
3.5; 3.7; 3.7; 3.8; 3.8; 3.9 | — |
| SECONDARY Change of Functional Ambulation Classification (FAC) Score From Injection Cycle Baseline Visits to Respective Control Visits |
0.1; 0.1; 0.1 | — |
| SECONDARY Change of Functional Ambulation Classification (FAC) Score From Study Baseline Visit to Control Visits of Injection Cycles |
0.1; 0.3; 0.4 | — |
| SECONDARY Change of Functional Ambulation Classification (FAC) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit |
0.2; 0.3; 0.4 | — |
| SECONDARY Goal Attainment Scale (GAS) Scores for Upper and Lower Limb, Respectively |
7.178; 10.601; 13.028; 8.222; 10.914; 13.579 | — |
| SECONDARY Disability Assessment Scale (DAS) Scores in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb |
2.6; 2.0; 2.4; 1.7; 2.2; 1.5 | — |
| SECONDARY Change of Disability Assessment Scale (DAS) Score in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb From Injection Cycle Baseline Visits to Respective Control Visits |
-0.6; -0.7; -0.7 | — |
| SECONDARY Change of Disability Assessment Scale (DAS) Score in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb From Study Baseline Visit to Control Visits of Injection Cycles |
-0.6; -0.9; -1.0 | — |
| SECONDARY Change of Disability Assessment Scale (DAS) Score in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit. |
-0.2; -0.3; -0.9 | — |
| SECONDARY Global Assessment of Efficacy Scores |
7; 21; 38; 79; 89; 87 | — |
| SECONDARY EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores |
12; 27; 14; 24; 19; 20 | — |
| SECONDARY Visual Analogue Scale (VAS) of EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores |
59.9; 66.7; 67.2; 69.9; 67.1; 68.9 | — |
| SECONDARY Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits |
18; 11; 6; 135; 136; 128 | — |
| SECONDARY Change in Visual Analogue Scale of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits |
6.7; 2.4; 1.7 | — |
| SECONDARY Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles |
18; 16; 14; 135; 127; 118 | — |
| SECONDARY Change in Visual Analogue Scale of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles |
6.7; 9.6; 8.6 | — |
| SECONDARY Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit |
10; 13; 16; 137; 121; 116 | — |
| SECONDARY Change in Visual Analogue Scale of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit |
7.1; 6.9; 10.5 | — |
Summary
The purpose of this study is to determine whether injections with increasing doses (up to 800 units) of Botulinum toxin type A into muscles of the leg and/or arm are safe and effective in treating patients with spasticity on one body side due to cerebral causes.
Eligibility Criteria
Inclusion Criteria
- Upper and lower limb spasticity of the same body side due to cerebral causes
- Time since event leading to spasticity in the target body side greater than 12 weeks
- Need for 800 units Botulinum toxin type A
Exclusion Criteria
- Body weight below 50kg
- Fixed contractures of the target joint
- 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 (NCT01603459). 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.