Last updated: 11/03/2018 16:55:50
A Multicenter, Open-label, Single Dose Study of the Safety and Efficacy of GSK1358820 (Botulinum Toxin Type A) in Chinese Subjects with post-stroke focal upper limb spasticityN/A
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Multicenter, Open-label, Single Dose Study of the Safety and Efficacy of GSK1358820 (Botulinum Toxin Type A) in Chinese Subjects with post-stroke focal upper limb spasticity
Trial description: This trial is a multicenter, open-label study to evaluate the safety and efficacy of GSK1358820 for treatment in post-stroke subjects with focal wrist, finger and in some cases, thumb spasticity. Qualified patients who complete GSK double-blind study 112958 will be enrolled. Subjects will receive a single treatment session of intramuscular GSK1358820 "200U or 240U (if thumb spasticity is present)". The subjects will be observed until 12 weeks post injection. Outcome measures include changes from baseline at every post injection visit as measured on the Modified Ashworth Scale (MAS), Disability Assessment Scale (DAS) and Global Assessment Scale. Safety parameters will be measured including adverse events, vital signs (pulse and blood pressure) and clinical laboratory tests (haematology, serum chemistry and urinanalysis).
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Change from Baseline at Week 6 and Week 12 for wrist flexor muscle tone as measured on the Modified Ashworth Scale (MAS)
Timeframe: Baseline (Day 0), Week 6, and Week 12
Secondary outcomes:
Number of participants classified as wrist treatment responders at Week 6 and Week 12
Timeframe: Baseline (Day 0), Week 6, and Week 12
Change from Baseline at Week 6 and Week 12 for finger flexor muscle tone as measured on the MAS
Timeframe: Baseline (Day 0), Week 6, and Week 12
Change from Baseline at Week 6 and Week 12 for thumb flexor muscle tone as measured on the MAS
Timeframe: Baseline (Day 0), Week 6, and Week 12
Change from Baseline at Week 6 and Week 12 for the principal measure as assessed on the Disability Assessment Scale (DAS)
Timeframe: Baseline (Day 0), Week 6, and Week 12
Global Assessment Scale (GAS) score as evaluated by the physician at Week 6 and Week 12
Timeframe: Week 6 and Week 12
GAS score as evaluated by the care giver or the participant at Week 6 and Week 12
Timeframe: Week 6 and Week 12
Mean change from Baseline in red blood cell (RBC) count at the exit visit
Timeframe: Baseline (Day 0) and exit visit (Week 12 or earlier)
Mean change from Baseline in white blood cell (WBC) and platelet count at the exit visit
Timeframe: Baseline (Day 0) and the exit visit (Week 12 or earlier)
Mean change from Baseline in the percentage of neutrophils, the percentage of lymphocytes, the percentage of monocytes, the percentage of eosinophils, and the percentage of basophils at the exit visit
Timeframe: Baseline (Day 0) and the exit visit (Week 12 or earlier)
Mean change from Baseline in hemoglobin content at the exit visit
Timeframe: Baseline (Day 0) and the exit visit (Week 12 or earlier)
Mean change from Baseline in hematocrit value at the exit visit
Timeframe: Baseline (Day 0) and the exit visit (Week 12 or earlier)
Mean change from Baseline in total protein and albumin values at the exit visit
Timeframe: Baseline (Day 0) and the exit visit (Week 12 or earlier)
Mean change from Baseline in serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (y-GT), and alkaline phosphatase (ALP) values at the exit visit
Timeframe: Baseline (Day 0) and the exit visit (Week 12 or earlier)
Mean change from Baseline in serum creatinine, uric acid, and total bilirubin values at the exit visit
Timeframe: Baseline (Day 0) and the exit visit (Week 12 or earlier)
Mean change from Baseline in serum blood urea nitrogen (BUN), fasting blood glucose (FBG), sodium, potassium, chloride, total cholesterol, and triglyceride values at the exit visit
Timeframe: Baseline (Day 0) and the exit visit (Week 12 or earlier)
Number of participants with clinically significant abnormalities of urinalysis at the Screening and exit visits
Timeframe: Screening visit (-Week 1) and the exit visit (Week 12 or earlier)
Mean change from Baseline in systolic blood pressure (BP) and diastolic BP at the exit visit
Timeframe: Baseline (Day 0) and the exit visit (Week 12 or earlier)
Mean change from Baseline in pulse rate at the exit visit
Timeframe: Baseline (Screening) and the exit visit (Week 12 or earlier)
Interventions:
Drug: Botulinum toxin type A
Enrollment:
109
Observational study model:
Not applicable
Primary completion date:
2012-19-03
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Spasticity, Post-Stroke
Product
OnabotulinumtoxinA
Collaborators
GSK
Study date(s)
September 2010 to March 2012
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 76 years
Accepts healthy volunteers
No
- 1. Within 3 months after completion of the GSK/Allergan study 112958.
- 2. Wrist flexor muscle tone of 2 or greater and finger flexor muscle tone of 1 or greater as measured on MAS (0 to 4).
- 1. Presence of fixed contracture of the study limb (absence of passive range of motion).
- 2. Profound atrophy of muscles to be injected (in the investigators opinion).
Inclusion and exclusion criteria
Inclusion criteria:
- 1. Within 3 months after completion of the GSK/Allergan study 112958. 2. Wrist flexor muscle tone of 2 or greater and finger flexor muscle tone of 1 or greater as measured on MAS (0 to 4). 3. At least one functional disability item (i.e., hygiene, dressing, pain, or cosmesis) with a rating of 2 or greater on DAS (0 to 3). 4. If using physical therapy, must be stable for at least 1 month prior to study enrolment in study 112958. 5. >=40kg in weight. 6. QTc criteria: (either QTcb or QTcf, machine or manual overread, males or females); include the following details as appropriate: QTc<450 millisecond (msec) or <480msec for subjects with Bundle Branch Block – values based on either single electrocardiogram (ECG) values or triplicate ECG averaged QTc values obtained over a brief recording period. 7. Liver function tests: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2xULN; alkaline phosphatase and bilirubin ≤1.5xULN (isolated bilirubin >1.5ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). 8. In the opinion of the investigator, subject must clearly understand the intent of the study and be willing and able to comply with study instructions and complete the entire study. 9. Informed consent has been obtained
Exclusion criteria:
- 1. Presence of fixed contracture of the study limb (absence of passive range of motion). 2. Profound atrophy of muscles to be injected (in the investigators opinion). 3. Infection or dermatological condition at the injection sites. 4. Significant inflammation in the study limb limiting joint movement. 5. History of or planned treatment for spasticity with phenol or alcohol block in the study limb. 6. History of or planned surgical intervention for spasticity of the study limb. 7. History (within 3 months of qualification) of or planned (during study period) casting of the study limb. 8. Participation in another clinical study (with the exception of study 112958) , within the 30 days immediately prior to enrolment. 9. Planned or anticipated initiation of new antispasticity medications during the clinical study. 10. Any medical condition that may put the subject at increased risk with exposure to GSK1358820, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other disorder that might have interfered with neuromuscular function. 11. Concurrent use of aminoglycoside antibiotics or other agents that might interfere with neuromuscular function. A full list of prohibited medications that interfere with neuromuscular transmission is provided as Appendix 1. 12. Current treatment for spasticity with an intrathecal baclofen. 13. Females who are pregnant, nursing, or planning a pregnancy during the study period, or females of childbearing potential, not using a reliable means of contraception. 14. Known allergy or sensitivity to study medication or its components. 15. Bedridden subjects. 16. Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). 17. Presence of clinically unstable severe cardiovascular, renal or respiratory disease. 18. Investigator's opinion that the subject has a concurrent condition(s) that may put the subject at significant risk, may confound the study results, or may interfere significantly with the conduct of the study.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2012-19-03
Actual study completion date
2012-19-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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