Phase 3
N=258
Dysport® Adult Upper Limb Spasticity Extension Study
Nervous System Disorders
Bottom Line
View on ClinicalTrials.gov: NCT01313312 ↗Enrolled (actual)
258
Serious AEs
8.3%
Results posted
Jun 2017
Primary outcome: Primary: Assessment of the Long-term Safety of Dysport® Through the Collection of Treatment Emergent Adverse Events (TEAEs) — 102; 62; 47; 11 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
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessment of the Long-term Safety of Dysport® Through the Collection of Treatment Emergent Adverse Events (TEAEs) |
102; 62; 47; 11; 2; 18 | — |
| PRIMARY Mean Change From Baseline to End of Study/Early Withdrawal in Diastolic and Systolic Blood Pressure (BP) |
0; -2.8 | — |
| PRIMARY Mean Change From Baseline to End of Study/Early Withdrawal in Heart Rate (HR) |
2.5 | — |
| PRIMARY Mean Change From Baseline to End of Study/Early Withdrawal in Red Blood Cell (RBC) Count |
0.03 | — |
| PRIMARY Mean Change From Baseline to End of Study/Early Withdrawal in Haemoglobin and Mean Corpuscular Haemoglobin Concentration (MCHC) |
-0.7; -0.8 | — |
| PRIMARY Mean Change From Baseline to End of Study/Early Withdrawal in Haematocrit |
-0.0011 | — |
| PRIMARY Mean Change From Baseline to End of Study/Early Withdrawal in Mean Corpuscular Haemoglobin (MCH) |
-0.33 | — |
| PRIMARY Mean Change From Baseline to End of Study/Early Withdrawal in Mean Corpuscular Volume (MCV) |
-0.77 | — |
| PRIMARY Mean Change From Baseline to End of Study/Early Withdrawal in White Blood Cell (WBC) Count, Neutrophils, Lymphocytes and Platelets |
0.04; 0; 0.01; 3.2 | — |
| PRIMARY Mean Change From Baseline to End of Study/Early Withdrawal in 12-Lead Electrocardiogram (ECG) |
403.6; -6.3; 417.8; -1; 425.6; 1.9 | — |
| PRIMARY Mean Change From Baseline to End of Study/Early Withdrawal in Alkaline Phosphatase (ALP), Gamma Glutamyl Transferase (GGT), Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT) |
-0.6; 1.4; 1.2; 1.5 | — |
| PRIMARY Mean Change From Baseline to End of Study/Early Withdrawal in Total Bilirubin and Creatinine |
-0.27; -3.7 | — |
| PRIMARY Mean Change From Baseline to End of Study/Early Withdrawal in Blood Urea Nitrogen (BUN) and Fasting Blood Glucose |
-0.033; 0.132 | — |
| PRIMARY Mean Change From Baseline to End of Study/Early Withdrawal in 12 Lead ECG - HR |
68.2; 2.7 | — |
| PRIMARY Number of Subjects With Botulinum Toxin A Binding and Neutralising Putative Antibodies |
5; 20; 4; 11 | — |
| SECONDARY Mean Change From Baseline Modified Ashworth Scale (MAS) in the Overall Primary Targeted Muscle Group (PTMG) for Upper Limb at Week 4 |
-1.4; -1.6; -1.5; -1.4 | — |
| SECONDARY Percentage of Subjects With at Least 1 or 2 Grade Reduction in MAS for Overall PTMG |
77.6; 79.5; 77.1; 75.3; 42.1; 48.0 | — |
| SECONDARY Mean Change From Baseline MAS in the Extrinsic Finger Flexors at Week 4 |
-1.3; -1.5; -1.5; -1.3 | — |
| SECONDARY Percentage of Subjects With at Least 1 or 2 Grade Reduction in MAS for Extrinsic Finger Flexors at Week 4 |
78.6; 81.3; 80; 80.4; 44.1; 49.3 | — |
| SECONDARY Mean Change From Baseline MAS in the Wrist Flexors at Week 4 |
-1.5; -1.6; -1.6; -1.5 | — |
| SECONDARY Percentage of Subjects With at Least 1 or 2 Grade Reduction in MAS for Wrist Flexors at Week 4 |
62.5; 74.3; 73.9; 50; 47.5; 54.3 | — |
| SECONDARY Mean Change From Baseline MAS in the Elbow Flexors at Week 4 |
-1.0; -1.1; -1.1; -0.8 | — |
| SECONDARY Percentage of Subjects With at Least 1 or 2 Grade Reduction in MAS for Elbow Flexors at Week 4 |
84.1; 78.3; 75.6; 73.3; 34.8; 41.7 | — |
| SECONDARY Mean Change From Baseline MAS in the Shoulder Extensors at Week 4 |
-0.9; -0.7; -0.6; -0.6 | — |
| SECONDARY Physician's Global Assessment (PGA) of Treatment Response at Week 4 |
1.7; 1.9; 1.9; 2 | — |
| SECONDARY Mean Change From Baseline in Disability Assessment Scale (DAS) Score for the Principal Target of Treatment (PTT) at Week 4 |
-0.9; -1.1; -1.1; -1.1 | — |
| SECONDARY Percentage of Subjects With at Least 1 Grade Reduction in DAS for PTT at Week 4 |
68.5; 75.1; 73.7; 74.1 | — |
| SECONDARY Percentage of Subjects With at Least One Grade Reduction in DAS for Individual Domains at Week 4 |
40.9; 45.4; 44.6; 46.9; 40.9; 47.2 | — |
| SECONDARY Mean Change From Baseline to Week 4 for Angle of Arrest (XV1), Angle of Catch (XV3) and Angle of Spasticity (X) in Extrinsic Finger Flexors as PTMG |
-33.5; -33.9; -43.3; -35.9; 24.3; 25.9 | — |
| SECONDARY Mean Change From Baseline to Week 4 for Spasticity Grade (Y) in Extrinsic Finger Flexors as PTMG |
-0.6; -0.6; -0.6; -0.5 | — |
| SECONDARY Mean Change From Baseline to Week 4 for Angle of Arrest (XV1), Angle of Catch (XV3) and Angle of Spasticity (X) in Elbow Flexors as PTMG |
-26.4; -31; -33.3; -46.4; -0.4; 1.3 | — |
| SECONDARY Mean Change From Baseline to Week 4 for Spasticity Grade (Y) in Elbow Flexors as PTMG |
-0.3; -0.4; -0.5; -0.6 | — |
| SECONDARY Mean Change From Baseline to Week 4 for Angle of Arrest (XV1), Angle of Catch (XV3) and Angle of Spasticity (X) in Wrist Flexors as PTMG |
-23.3; -28.8; -21.7; -13.5; 12.6; 16.4 | — |
| SECONDARY Mean Change From Baseline to Week 4 for Spasticity Grade (Y) in Wrist Flexors as PTMG |
-0.7; -0.9; -0.6; -0.3 | — |
| SECONDARY Mean Change From Baseline to Week 4 for Angle of Arrest (XV1), Angle of Catch (XV3) and Angle of Spasticity (X) in Shoulder Extensors |
-13.3; -10.8; -6.4; -7.2; 7.2; 6.4 | — |
| SECONDARY Mean Change From Baseline to Week 4 for Spasticity Grade (Y) in Shoulder Extensors |
-0.1; -0.1; -0.2; -0.2 | — |
| SECONDARY Mean Change From Baseline in Active Range of Motion (AROM) at Week 4 in the 3 Possible PTMGs |
31.3; 34.4; 33.5; 38; 10.7; 17.6 | — |
| SECONDARY Mean Change From Baseline at Week 4 in Ease of Applying a Splint |
-0.4; -0.4; -0.4; -0.4 | — |
| SECONDARY Mean Change From Baseline in Modified Frenchay Scale (MFS) at Week 4 |
0.4; 0.51; 0.44; 0.4 | — |
| SECONDARY Mean Change From Baseline in Short Form (36) Health Survey (SF-36) Quality of Life (QoL) at End of Study/Early Withdrawal Visit |
37.49; 1.07; 46.88; 0.96 | — |
| SECONDARY Mean Change From Baseline in European 5 Dimensions, 5 Level (EQ-5D-5L) QoL at End of Study/Early Withdrawal Visit |
1.9; -0.1; 2.8; 0; 2.1; -0.2 | — |
Summary
The purpose of this research study is to assess the long term safety of Dysport® in hemiparetic subjects with upper limb spasticity due to stroke or traumatic brain injury over repeated treatment cycles.
Eligibility Criteria
Inclusion Criteria
- Completion of the double blind study, Y-52-52120-145
Exclusion Criteria
- Major limitation in the passive range of motion in upper limb
Data sourced from ClinicalTrials.gov (NCT01313312). 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.