Phase 3
Completed N=192
IncobotulinumtoxinA (Xeomin) for Upper Limb Spasticity
Upper Limb Spasticity
Source: ClinicalTrials.gov NCT00465738 ↗
Enrolled (actual)
192
Serious AEs
6.3%
Results posted
Dec 2010
Primary outcomePrimary: Responder in Disability Assessment Scale (DAS) at Week 4 - Per Protocol Set — 51; 44 participants
Summary
This study will investigate the efficacy and safety of incobotulinumtoxinA (Xeomin) in the treatment of arm tightness (upper limb spasticity) using two different dilutions of incobotulinumtoxinA (Xeomin).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Responder in Disability Assessment Scale (DAS) at Week 4 - Per Protocol Set |
51; 44 | — |
| SECONDARY Responder in DAS at Week 4 - Full Analysis Set |
59; 49 | — |
| SECONDARY Responder in DAS at Week 12 - Full Analysis Set |
46; 38 | — |
| SECONDARY Responder in DAS at Follow up - Full Analysis Set |
40; 33 | — |
| SECONDARY Responder in Frenchay Arm Test (FAT) at Week 4 - Full Analysis Set |
17; 24 | — |
| SECONDARY Responder in FAT at Week 12 - Full Analysis Set |
20; 22 | — |
| SECONDARY Responder in FAT at Follow up - Full Analysis Set |
12; 15 | — |
| SECONDARY Responder in Ashworth Scale (Elbow Flexors) at Week 4 - Full Analysis Set |
47; 50 | — |
| SECONDARY Responder in Ashworth Scale (Elbow Flexors) at Week 12 - Full Analysis Set |
37; 40 | — |
| SECONDARY Responder in Ashworth Scale (Elbow Flexors) at Follow up - Full Analysis Set |
30; 21 | — |
| SECONDARY Responder in Ashworth Scale (Wrist Flexors) at Week 4 - Full Analysis Set |
68; 63 | — |
| SECONDARY Responder in Ashworth Scale (Wrist Flexors) at Week 12 - Full Analysis Set |
43; 46 | — |
| SECONDARY Responder in Ashworth Scale (Wrist Flexors) at Follow up - Full Analysis Set |
31; 28 | — |
| SECONDARY Responder in Ashworth Scale (Thumb Flexors) at Week 4 - Full Analysis Set |
29; 19 | — |
| SECONDARY Responder in Ashworth Scale (Thumb Flexors) at Week 12 - Full Analysis Set |
21; 13 | — |
| SECONDARY Responder in Ashworth Scale (Thumb Flexors) at Follow up - Full Analysis Set |
18; 9 | — |
| SECONDARY Responder in Ashworth Scale (Fingers Flexors) at Week 4 - Full Analysis Set |
57; 48 | — |
| SECONDARY Responder in Ashworth Scale (Fingers Flexors) at Week 12 - Full Analysis Set |
35; 35 | — |
| SECONDARY Responder in Ashworth Scale (Fingers Flexors) at Follow up - Full Analysis Set |
17; 20 | — |
| SECONDARY Responder in Ashworth Scale (Forearm Pronators) at Week 4 - Full Analysis Set |
32; 30 | — |
| SECONDARY Responder in Ashworth Scale (Forearm Pronators) at Week 12 - Full Analysis Set |
28; 22 | — |
| SECONDARY Responder in Ashworth Scale (Forearm Pronators) at Follow up - Full Analysis Set |
18; 16 | — |
| SECONDARY Change From Baseline in Passive Range of Motion (PROM) - Wrist Extension |
14.8; 15.7; 7.3; 10.4; 8.2; 10.4 | — |
| SECONDARY Change From Baseline in Passive Range of Motion (PROM) - Elbow Extension |
8.0; 5.8; 6.1; 2.1; 3.9; 4.1 | — |
| SECONDARY Change From Baseline in Passive Range of Motion (PROM) - Wrist Maximum Flexion |
-1.2; 5.2; -1.3; 2.9; -1.3; 3.8 | — |
| SECONDARY Change From Baseline in Passive Range of Motion (PROM) - Elbow Maximum Flexion |
0.1; 2.7; -0.7; 2.6; -1.9; 1.0 | — |
| SECONDARY Investigator's Global Assessment of Treatment Response (GATR) - Full Analysis Set |
1.66; 1.59 | — |
| SECONDARY Patient's Global Assessment of Treatment Response (GATR) - Full Analysis Set |
1.41; 1.48 | — |
| SECONDARY Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Feeding |
7; 5 | — |
| SECONDARY Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Feeding |
8; 6 | — |
| SECONDARY Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Feeding |
7; 5 | — |
| SECONDARY Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Grooming |
5; 6 | — |
| SECONDARY Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Grooming |
7; 10 | — |
| SECONDARY Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Grooming |
7; 6 | — |
| SECONDARY Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Toilet Use |
7; 6 | — |
| SECONDARY Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Toilet Use |
11; 7 | — |
| SECONDARY Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Toilet Use |
11; 5 | — |
| SECONDARY Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Bathing/Showering |
1; 7 | — |
| SECONDARY Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Bathing/Showering |
4; 6 | — |
| SECONDARY Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Bathing/Showering |
2; 4 | — |
| SECONDARY Response Rates in Activity of Daily Living (Barthel Index) at Week 4 - Item Dressing |
9; 6 | — |
| SECONDARY Response Rates in Activity of Daily Living (Barthel Index) at Week 12 - Item Dressing |
10; 8 | — |
| SECONDARY Response Rates in Activity of Daily Living (Barthel Index) at Follow up - Item Dressing |
8; 7 | — |
Eligibility Criteria
Main Inclusion Criteria:
- Female or male patients ≥ 18 years
- Stable upper limb spasticity of diverse etiology
- Focal spasticity with equal or more than 2 points on the Ashworth scale in the wrist flexors
- Disability Assessment Scale (DAS) ≥ 2 points for primary therapeutic target at both screening and baseline visits
Main Exclusion Criteria:
- Fixed contracture
- Bilateral upper limb paresis/paralysis
- Previous treatment with BoNT of any serotype and for any body region within the 4 months prior to screening
- Previous or planned treatment with phenol- or alcohol-injection in the target limb
- Other muscle hypertonia (e.g. rigidity)
- Diagnosis of myasthenia gravis, Lambert-Eaton-Syndrome, amyotrophic lateral sclerosis, or any other significant neuromuscular disease which might interfere with the study
- Severe atrophy of the target limb muscles
Data sourced from ClinicalTrials.gov (NCT00465738). 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. Informational only — not medical advice.