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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Assessment of the Long-Term Safety of Dysport® Through the Collection of Treatment Emergent Adverse Events (TEAEs)
Timeframe: Up to EOS (maximum duration of 52 weeks).
Mean Change From Baseline to Week 4 in Systolic and Diastolic Blood Pressure (BP)
Timeframe: Baseline and Week 4 of each cycle
Mean Change From Baseline to Week 4 in Heart Rate (HR)
Timeframe: Baseline and Week 4 of each cycle
Mean Change From Baseline to Week 4 in Red Blood Cell (RBC) Count
Timeframe: Baseline and Week 4 of each cycle
Mean Change From Baseline to Week 4 in Haemoglobin and Mean Corpuscular Haemoglobin Concentration (MCHC)
Timeframe: Baseline and Week 4 of each cycle
Mean Change From Baseline to Week 4 in Haematocrit
Timeframe: Baseline and Week 4 of each cycle
Mean Change From Baseline to Week 4 in Mean Corpuscular Haemoglobin (MCH)
Timeframe: Baseline and Week 4 of each cycle
Mean Change From Baseline to Week 4 in Mean Corpuscular Volume (MCV)
Timeframe: Baseline and Week 4 of each cycle
Mean Change From Baseline to Week 4 in White Blood Cell (WBC) Count, Neutrophils, Lymphocytes and Platelets
Timeframe: Baseline and Week 4 of each cycle
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)
Timeframe: Baseline and Week 4 of each cycle
Mean Change From Baseline to Week 4 in Total Bilirubin and Creatinine
Timeframe: Baseline and Week 4 of each cycle
Mean Change From Baseline to Week 4 in Blood Urea Nitrogen (BUN) and Fasting Blood Glucose
Timeframe: Baseline and Week 4 of each cycle
Presence of Botulinum Toxin Type A (BTX-A) Neutralising Putative Antibodies (NAbs) Following Injection of Dysport®
Timeframe: At Week 4
Mean Change From Baseline to Week 4 in 12-Lead Electrocardiogram (ECG)
Timeframe: Baseline and Week 4 of each cycle