Phase 3
N=345
Dysport® Adult Lower Limb Spasticity Follow-on Study
Post-stroke Spasticity · Spasticity Post-Traumatic Brain Injury
Bottom Line
View on ClinicalTrials.gov: NCT01251367 ↗Enrolled (actual)
345
Serious AEs
12.5%
Results posted
Nov 2017
Primary outcome: Primary: Assessment of the Long-Term Safety of Dysport® Through the Collection of Treatment Emergent Adverse Events (TEAEs) — 140; 97; 47; 21 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Botulinum toxin type A (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ipsen
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessment of the Long-Term Safety of Dysport® Through the Collection of Treatment Emergent Adverse Events (TEAEs) |
140; 97; 47; 21; 43; 23 | — |
| PRIMARY Mean Change From Baseline to Week 4 in Systolic and Diastolic Blood Pressure (BP) |
-0.7; -1.9; -2.4; -5.1; 0.3; -0.2 | — |
| PRIMARY Mean Change From Baseline to Week 4 in Heart Rate (HR) |
3.7; 4.9; 3.9; 4.5 | — |
| PRIMARY Mean Change From Baseline to Week 4 in Red Blood Cell (RBC) Count |
0.049; 0.074; 0.046; 0.028 | — |
| PRIMARY Mean Change From Baseline to Week 4 in Haemoglobin and Mean Corpuscular Haemoglobin Concentration (MCHC) |
1.2; 1.5; 1.5; 1.2; 1.9; 1.3 | — |
| PRIMARY Mean Change From Baseline to Week 4 in Haematocrit |
0.001; 0.003; -0.001; -0.009 | — |
| PRIMARY Mean Change From Baseline to Week 4 in Mean Corpuscular Haemoglobin (MCH) |
-0.06; -0.17; 0.00; 0.05 | — |
| PRIMARY Mean Change From Baseline to Week 4 in Mean Corpuscular Volume (MCV) |
-0.74; -0.9; -1.02; -2.44 | — |
| PRIMARY Mean Change From Baseline to Week 4 in White Blood Cell (WBC) Count, Neutrophils, Lymphocytes and Platelets |
-0.21; -0.32; -0.26; -0.02; -0.17; -0.27 | — |
| PRIMARY Mean Change From Baseline to Week 4 in Alkaline Phosphatase (ALP), Gamma Glutamyl Transferase (GGT), Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT) |
-1.2; -2.9; -5.2; -3.2; 2.7; 3 | — |
| PRIMARY Mean Change From Baseline to Week 4 in Total Bilirubin and Creatinine |
0.13; 0.14; 0.03; -0.05; -2; -5.3 | — |
| PRIMARY Mean Change From Baseline to Week 4 in Blood Urea Nitrogen (BUN) and Fasting Blood Glucose |
0.14; -0.05; -0.19; -0.37; -0.046; 0.009 | — |
| PRIMARY Presence of Botulinum Toxin Type A (BTX-A) Neutralising Putative Antibodies (NAbs) Following Injection of Dysport® |
3; 0 | — |
| PRIMARY Mean Change From Baseline to Week 4 in 12-Lead Electrocardiogram (ECG) |
-10.1; -12.2; -13.6; -16.5; -0.6; -1.9 | — |
| SECONDARY Mean Change From Baseline to Week 4 in the Modified Ashworth Scale (MAS) Score Measured in the Gastrocnemius-soleus Complex (GSC) (Knee Extended) |
-0.8; -0.9; -1; -1 | — |
| SECONDARY Mean Change From Baseline to Week 4 in the MAS Measured in the Soleus Muscle (Knee Flexed) |
-1; -1.1; -1.2; -1.1 | — |
| SECONDARY Percentage of Subjects With At Least a 1 or 2 Grade Reduction in the MAS Measured in the GSC (Knee Extended) at Week 4 |
56.2; 57.6; 60.7; 66.9; 18.3; 23.2 | — |
| SECONDARY Percentage of Subjects With At Least a 1 or 2 Grade Reduction in the MAS Measured in the Soleus Muscle (Knee Flexed) at Week 4 |
61.4; 68.4; 72.3; 71.9; 28.4; 30.6 | — |
| SECONDARY Physician's Global Assessment (PGA) of Treatment Response at Week 4 |
1.4; 1.6; 1.8; 1.9 | — |
| SECONDARY Percentage of Subjects With a Score of at Least +1 on the PGA Scale at Week 4 |
83.8; 86.2; 89.3; 89.9 | — |
| SECONDARY Mean Change From Baseline to Week 4 in the Range of Active Ankle Dorsiflexion Both With the Knee Flexed and With the Knee Extended |
4.1; 4.4; 6; 6.5; 4.1; 5 | — |
| SECONDARY Mean Change From Baseline to Week 4 in Lower Limb Pain |
-0.7; -0.8; -0.9; -0.9 | — |
| SECONDARY Mean Change From Baseline to Week 4 in Short Form (36) Health Survey (SF-36) Quality of Life (QoL) |
1.05; 1.43; 1.85; 2.8; -1.13; -0.82 | — |
| SECONDARY Mean Change From Baseline in European Quality of Life - 5 Dimensions, 5 Level (EQ-5D-5L) QoL |
-0.1; -0.2; -0.2; -0.4; 2.8; 3.8 | — |
| SECONDARY Mean Change From Baseline to Week 4 in Walking Speed (WS) |
0.07; 0.08; 0.08; 0.09; 0.06; 0.07 | — |
| SECONDARY Mean Change From Baseline to Week 4 in Step Length |
0.03; 0.03; 0.03; 0.05; 0.03; 0.03 | — |
| SECONDARY Mean Change From Baseline to Week 4 in Cadence |
0.08; 0.08; 0.08; 0.07; 0.07; 0.08 | — |
| SECONDARY Mean Change From Baseline to Week 4 in Angle of Arrest (XV1), Angle of Catch (XV3) and Spasticity Angle (X) in the GSC (Knee Extended) |
2.7; 2.4; 2.6; 2.7; 7.1; 7.3 | — |
| SECONDARY Mean Change From Baseline to Week 4 in Spasticity Grade (Y) in the GSC (Knee Extended) |
-0.5; -0.5; -0.5; -0.5 | — |
| SECONDARY Mean Change From Baseline to Week 4 in Angle of Arrest (XV1), Angle of Catch (XV3) and Spasticity Angle (X) in the Soleus Muscle (Knee Flexed) |
1.9; 2.8; 2.6; 2.4; 6.9; 7.5 | — |
| SECONDARY Mean Change From Baseline to Week 4 in Spasticity Grade (Y) in the Soleus Muscle (Knee Flexed) |
-0.6; -0.6; -0.7; -0.7 | — |
| SECONDARY Use of Walking Aids/Orthoses at Baseline and Week 4 |
101; 244; 99; 242; 84; 213 | — |
Summary
The purpose of this research study is to assess the long term safety of Dysport® in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury over repeated treatment cycles.
Eligibility Criteria
Inclusion Criteria
- Completion of Dysport® Adult Lower Limb Spasticity Double Blind study Y-55-52120-140 (NCT01249404)
Exclusion Criteria
- Fixed contractures in lower limb
Data sourced from ClinicalTrials.gov (NCT01251367). 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.