Spasticity, Post-StrokePhase 3NCT01205451
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
A Phase 3 study testing Botulinum toxin type A in people with Spasticity, Post-Stroke, run by GlaxoSmithKline at 13 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Spasticity, Post-Stroke
- What is being tested?
- Botulinum toxin type A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 13 sitesChina
- Study dates
- Sep 2010to Mar 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Within 3 months after completion of the GSK/Allergan study 112958.
- Wrist flexor muscle tone of 2 or greater and finger flexor muscle tone of 1 or greater as measured on MAS (0 to 4).
- 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).
- If using physical therapy, must be stable for at least 1 month prior to study enrolment in study 112958.
- >=40kg in weight.
- 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.
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- 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%).
- 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.
- Informed consent has been obtained
Who cannot join
- Presence of fixed contracture of the study limb (absence of passive range of motion).
- Profound atrophy of muscles to be injected (in the investigators opinion).
- Infection or dermatological condition at the injection sites.
- Significant inflammation in the study limb limiting joint movement.
- History of or planned treatment for spasticity with phenol or alcohol block in the study limb.
- History of or planned surgical intervention for spasticity of the study limb.
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- History (within 3 months of qualification) of or planned (during study period) casting of the study limb.
- Participation in another clinical study (with the exception of study 112958) , within the 30 days immediately prior to enrolment.
- Planned or anticipated initiation of new antispasticity medications during the clinical study.
- 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.
- 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.
- Current treatment for spasticity with an intrathecal baclofen.
- 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.
- Known allergy or sensitivity to study medication or its components.
- Bedridden subjects.
- 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).
- Presence of clinically unstable severe cardiovascular, renal or respiratory disease.
- 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 locations and contacts
13 sites in 1 country.
13 sites in 1 country
China13 sites
GSK Investigational Site
Beijing, 100050
GSK Investigational Site
Beijing, 100068
GSK Investigational Site
Beijing, 100730
GSK Investigational Site
Chengdu, Sichuan, 610041
GSK Investigational Site
Guangzhou, Guangdong
GSK Investigational Site
Haerbin, Heilongjiang, 150001
GSK Investigational Site
Hangzhou, 310016
GSK Investigational Site
Nanjing, Jiangsu, 210029
GSK Investigational Site
Shanghai, 200025
GSK Investigational Site
Shanghai, 200040
GSK Investigational Site
Shenyang, Liaoning, 110001
GSK Investigational Site
Suzhou, Jiangsu, 215004
GSK Investigational Site
Wuhan, Hubei, 430060
About this study
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).
Read the detailed description
This trial is a multicenter, open-label study to evaluate the safety and efficacy of GSK1358820 for the treatment of patients with focal wrist, finger and in some cases, thumb spasticity post-stroke. Qualified patients will be eligible for enrollment upon completion of double-blind study 112958. Patients will receive a single treatment session with intramuscular injections of GSK1358820 "200U or 240U (if thumb spasticity is present)".The subjects will be observed for 12 weeks post injection.
Each completed subject will attend 4 clinic visits. The maximum study duration is 13 weeks. The study includes a 1 week pretreatment period, during which the screening visit (visit 1 could be the last visit of previous double-blind study 112958 or any time within 3 months after completion of previous study) is to take place. Only one upper limb (meeting inclusion/exclusion criteria) will be evaluated and treated in the study. Subjects will receive a single intramuscular treatment with investigated drug at day 0 (visit 2). There will be two post-injection follow-up visits at week 6 and 12 (visits 3 to 4).
- Conditions
- Spasticity, Post-Stroke
- Being tested
- Botulinum toxin type A
- Keywords
- GSK1358820, upper limb, spasticity, post-stroke
- Medical subject headings
- Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin type ADrug
Botulinum toxin type A
| Study group | Role | What they receive |
|---|---|---|
| BTX-A | Experimental | Botulinum toxin type A Receives: Drug: Botulinum toxin type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline at Week 6 and Week 12 for Wrist Flexor Muscle Tone as Measured on the Modified Ashworth Scale (MAS)
The investigator or assessor extended the participant's wrist as quickly as possible to grade flexor muscle tone. The MAS wrist score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Change from Baseline at Week 6 or Week 12 was calculated as the value at Week 6 or Week 12 minus the value at Baseline.
Measured: Baseline (Day 0), Week 6, and Week 12
Secondary outcomes (18)
Number of Participants Classified as Wrist Treatment Responders at Week 6 and Week 12
Wrist treatment responders are defined as participants with a decrease in wrist flexor muscle tone of at least one point on the MAS from Baseline. The MAS wrist score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension).
Measured: 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
The investigator or assessor extended the participant's finger as quickly as possible to grade the flexor muscle tone. The MAS finger score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Change from Baseline at Week 6 or Week 12 was calculated as the value at Week 6 or Week 12 minus the value at Baseline.
Measured: 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
The investigator or assessor extended the participant's thumb as quickly as possible to grade the flexor muscle tone. The MAS thumb score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Change from Baseline at Week 6 or Week 12 was calculated as the value at Week 6 or Week 12 minus the value at Baseline.
Measured: 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)
The investigator assessed 4 areas of disability, hygiene, pain, dressing, and limb posture, using the 4-point DAS (0=No functional disability to 3=Severe disability). Prior to the first dose, the investigator, in consultation with the participant, selected 1functional disability item (which had to have a score of 2 or greater as measured on the DAS, indicating moderate to severe disability) from the 4 areas of disability and assessed it as a principal measure. Change from Baseline at Week 6 or Week 12 was calculated as the value at Week 6 or Week 12 minus the value at Baseline.
Measured: Baseline (Day 0), Week 6, and Week 12
Global Assessment Scale (GAS) Score as Evaluated by the Physician at Week 6 and Week 12
The physician used the GAS to assess response to treatment at each visit after injection. The assessor was the same throughout the study period. GAS scores were assessed by using the 9-point GAS (-4, -3, -2, -1, -0, +1, +2, +3, +4; -4=very marked worsening, -0=unchanged, +4=very marked improvement) at Week 6 and Week 12.
Measured: Week 6 and Week 12
GAS Score as Evaluated by the Care Giver or the Participant at Week 6 and Week 12
The care giver or participant used the GAS to assess response to treatment at each visit after injection. The assessor was the same throughout the study period. GAS scores were assessed by using the 9-point GAS (-4, -3, -2, -1, -0, +1, +2, +3, +4; -4=very marked worsening, 0=unchanged, +4=very marked improvement) at Week 6 and Week 12.
Measured: Week 6 and Week 12
Mean Change From Baseline in Red Blood Cell (RBC) Count at the Exit Visit
Blood samples of participants were collected and evaluated for RBC count at Baseline and at the exit visit. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.
Measured: 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
Blood samples of participants were collected and evaluated for WBC count and platelet count at Baseline and at the exit visit. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.
Measured: 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
Blood samples of participants were collected and evaluated for the percentage of neutrophils, lymphocytes, monocytes, eosinophils, and basophils comprising the total WBC count in the blood at Baseline and at the exit visit. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.
Measured: Baseline (Day 0) and the exit visit (Week 12 or earlier)
Mean Change From Baseline in Hemoglobin Content at the Exit Visit
Blood samples of participants were collected and evaluated for hemoglobin at Baseline and at the exit visit. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.
Measured: Baseline (Day 0) and the exit visit (Week 12 or earlier)
Mean Change From Baseline in Hematocrit Value at the Exit Visit
The hematocrit, also called packed cell volume or erythrocyte volume fraction, is the volume percentage of red blood cells in the blood. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.
Measured: 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
Blood samples of participants were collected for a biochemical test of total protein and albumin, at Baseline and at the exit visit. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.
Measured: 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
Blood samples of participants were collected and evaluated for liver function, including measuring ALT, AST, y-GT, and ALP. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.
Measured: 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
Blood samples of participants were collected for a biochemical test of creatine, uric acid, and total bilirubin. Creatine and uric acid are evaluated for kidney function. The liver function test includes total bilirubin. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.
Measured: 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
Blood samples of participants were collected for biochemical tests of BUN, FBG, electrolytes, cholesterol, and triglycerides. The BUN test is primarily used to evaluate kidney function. Electrolytes include sodium, potassium, and chloride. Change from Baseline was calculated as the value at the exit visit minus the value at Baseline.
Measured: 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
Urine samples of participants were collected for urinalysis, including measuring protein, blood, leukocyte, glucose, and urobilinogen. All values out of the normal range were evaluated by the investigator. Classification of clinically significant and not clinically significant was based on the investigator's clinical judgment; no specific criteria were used.
Measured: 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
Systolic blood pressure (SBP) and diastolic BP of participants were measured in the sitting position. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.
Measured: Baseline (Day 0) and the exit visit (Week 12 or earlier)
Mean Change From Baseline in Pulse Rate at the Exit Visit
The pulse rate of participants was recorded. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.
Measured: Baseline (Screening) and the exit visit (Week 12 or earlier)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionDec 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spasticity, Post-StrokeStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01205451
- Sponsor's protocol ID
- 114609
- Status last verified
- Jan 2017
- First submitted
- 3 Sep 2010
- Last updated
- 28 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01205451
- Acronym / sponsor ID
- 114609
- Conditions
- Spasticity, Post-Stroke
- Keywords
- GSK1358820, upper limb, spasticity, post-stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 20 Sep 2010 (estimated)
- Results
- Posted 24 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This trial is a multicenter, open-label study to evaluate the safety and efficacy of GSK1358820 for the treatment of patients with focal wrist, finger and in some cases, thumb spasticity post-stroke. Qualified patients will be eligible for enrollment upon completion of double-blind study 112958. Patients will receive a single treatment session with intramuscular injections of GSK1358820 "200U or 240U (if thumb spasticity is present)".The subjects will be observed for 12 weeks post injection.
Each completed subject will attend 4 clinic visits. The maximum study duration is 13 weeks. The study includes a 1 week pretreatment period, during which the screening visit (visit 1 could be the last visit of previous double-blind study 112958 or any time within 3 months after completion of previous study) is to take place. Only one upper limb (meeting inclusion/exclusion criteria) will be evaluated and treated in the study. Subjects will receive a single intramuscular treatment with investigated drug at day 0 (visit 2). There will be two post-injection follow-up visits at week 6 and 12 (visits 3 to 4).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BTX-A | Experimental | Drug: Botulinum toxin type ABotulinum toxin type A |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Within 3 months after completion of the GSK/Allergan study 112958.
- Wrist flexor muscle tone of 2 or greater and finger flexor muscle tone of 1 or greater as measured on MAS (0 to 4).
- 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).
- If using physical therapy, must be stable for at least 1 month prior to study enrolment in study 112958.
- >=40kg in weight.
Key exclusion criteria (18 listed)
- Presence of fixed contracture of the study limb (absence of passive range of motion).
- Profound atrophy of muscles to be injected (in the investigators opinion).
- Infection or dermatological condition at the injection sites.
- Significant inflammation in the study limb limiting joint movement.
- History of or planned treatment for spasticity with phenol or alcohol block in the study limb.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin type ABotulinum toxin type A | Drug | BTX-A |
Primary outcome
Change From Baseline at Week 6 and Week 12 for Wrist Flexor Muscle Tone as Measured on the Modified Ashworth Scale (MAS)
Time frame: Baseline (Day 0), Week 6, and Week 12
The investigator or assessor extended the participant's wrist as quickly as possible to grade flexor muscle tone. The MAS wrist score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Change from Baseline at Week 6 or Week 12 was calculated as the value at Week 6 or Week 12 minus the value at Baseline.
18 secondary outcomes
Number of Participants Classified as Wrist Treatment Responders at Week 6 and Week 12
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Baseline (Day 0), Week 6, and Week 12
Global Assessment Scale (GAS) Score as Evaluated by the Physician at Week 6 and Week 12
Time frame: Week 6 and Week 12
GAS Score as Evaluated by the Care Giver or the Participant at Week 6 and Week 12
Time frame: Week 6 and Week 12
Mean Change From Baseline in Red Blood Cell (RBC) Count at the Exit Visit
Time frame: 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
Time frame: 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
Time frame: Baseline (Day 0) and the exit visit (Week 12 or earlier)
Mean Change From Baseline in Hemoglobin Content at the Exit Visit
Time frame: Baseline (Day 0) and the exit visit (Week 12 or earlier)
Mean Change From Baseline in Hematocrit Value at the Exit Visit
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline (Day 0) and the exit visit (Week 12 or earlier)
Mean Change From Baseline in Pulse Rate at the Exit Visit
Time frame: Baseline (Screening) and the exit visit (Week 12 or earlier)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botulinum toxin type A in people with Spasticity, Post-Stroke, run by GlaxoSmithKline at 13 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline at Week 6 and Week 12 for Wrist Flexor Muscle Tone as Measured on the Modified Ashworth Scale (MAS) (time frame: Baseline (Day 0), Week 6, and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2017; AzTrials last refreshed its copy on 26 Oct 2026.