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CompletedNCT01205451Updated Feb 28, 2017Results posted

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 interventional study of Botulinum toxin type A in Spasticity, Post-Stroke, sponsored by GlaxoSmithKline. Completed at 13 sites in China. Open to participants aged 18 Years to 76 Years. Per ClinicalTrials.gov, last updated 2017-02-28.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
109
Allocation
Not applicable
Ages
18 Years to 76 Years
Sex
All
01

Study 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. 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).

02

Conditions studied

  • Spasticity, Post-Stroke

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Keywords

  • GSK1358820
  • upper limb
  • spasticity
  • post-stroke
03

In context

Muscle Spasticity

713 studies on the registry are indexed under Muscle Spasticity; 148 are open to participants now.

This study's enrollment of 109 is above the median of 36 across 532 interventional studies indexed under Muscle Spasticity.

Browse Muscle Spasticity studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,647 studies on the registry; 118 are open to participants now.

Of its 264 completed or terminated interventional studies of FDA-regulated products, 239 (91%) have results posted.

Browse GlaxoSmithKline studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 76 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
109 participants (actual)

Study arms

  • Experimental
    BTX-A

    Botulinum toxin type A

    Drug: Botulinum toxin type A

Interventions

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline (Day 0), Week 6, and Week 12

Secondary outcomes

  1. 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).

    Time frame: Baseline (Day 0), Week 6, and Week 12

  2. 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.

    Time frame: Baseline (Day 0), Week 6, and Week 12

  3. 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.

    Time frame: Baseline (Day 0), Week 6, and Week 12

  4. 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.

    Time frame: Baseline (Day 0), Week 6, and Week 12

  5. 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.

    Time frame: Week 6 and Week 12

  6. 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.

    Time frame: Week 6 and Week 12

  7. 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.

    Time frame: Baseline (Day 0) and exit visit (Week 12 or earlier)

  8. 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.

    Time frame: Baseline (Day 0) and the exit visit (Week 12 or earlier)

  9. 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.

    Time frame: Baseline (Day 0) and the exit visit (Week 12 or earlier)

  10. 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.

    Time frame: Baseline (Day 0) and the exit visit (Week 12 or earlier)

  11. 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.

    Time frame: Baseline (Day 0) and the exit visit (Week 12 or earlier)

  12. 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.

    Time frame: Baseline (Day 0) and the exit visit (Week 12 or earlier)

  13. 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.

    Time frame: Baseline (Day 0) and the exit visit (Week 12 or earlier)

  14. 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.

    Time frame: Baseline (Day 0) and the exit visit (Week 12 or earlier)

  15. 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.

    Time frame: Baseline (Day 0) and the exit visit (Week 12 or earlier)

  16. 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.

    Time frame: Screening visit (-Week 1) and the exit visit (Week 12 or earlier)

  17. 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.

    Time frame: Baseline (Day 0) and the exit visit (Week 12 or earlier)

  18. 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.

    Time frame: Baseline (Screening) and the exit visit (Week 12 or earlier)

07

Results

Posted Sep 24, 2012

Participant flow

Participant flow — Overall Study
MilestoneBOTOX in Original DB Study; BOTOX in OL StudyPlacebo in Original DB Study; BOTOX in OL Study
Started5356
Completed4746
Not completed610
Withdrew: Lost to follow-up11
Withdrew: Withdrawal by subject59

Outcome measures

PrimaryChange 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.

Time frame:
Baseline (Day 0), Week 6, and Week 12
Reported as:
Mean · scores on a scale
Change From Baseline at Week 6 and Week 12 for Wrist Flexor Muscle Tone as Measured on the Modified Ashworth Scale (MAS)
scores on a scaleBOTOX in Original DB Study; BOTOX in OL StudyPlacebo in Original DB Study; BOTOX in OL Study
Week 6-1.21 ± 0.616-1.33 ± 0.753
Week 12-0.88 ± 0.589-1.12 ± 0.752
Statistical analysis
  • BOTOX in Original DB Study; BOTOX in OL Study · Wilcoxon signed-rank test · p = <0.0001 (The P-value for change from Baseline indicates the comparision of the Week 6 value against the Baseline value.) · T-distribution: -1.21 · 95% CI -1.38 to -1.04Confidence intervals for means were based on the t-distribution.
  • Placebo in Original DB Study; BOTOX in OL Study · Wilcoxon signed-rank test · p = <0.0001 (The P-value for change from Baseline indicates the comparision of the Week 6 value against the Baseline value.) · T-distribution: -1.33 · 95% CI -1.54 to -1.12Confidence intervals for means were based on the t-distribution.
  • BOTOX in Original DB Study; BOTOX in OL Study · Wilcoxon signed-rank test · p = <0.0001 (The P-value for change from Baseline indicates the comparision of the Week 12 value against the Baseline value.) · T-distribution: -0.88 · 95% CI -1.04 to -0.72Confidence intervals for means were based on the t-distribution.
  • Placebo in Original DB Study; BOTOX in OL Study · Wilcoxon signed-rank test · p = <0.0001 (The P-value for change from Baseline indicates the comparision of the Week 12 value against the Baseline value.) · T-distribution: -1.12 · 95% CI -1.33 to -0.91Confidence intervals for means were based on the t-distribution.
SecondaryNumber 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).

Time frame:
Baseline (Day 0), Week 6, and Week 12
Reported as:
Number · participants
Number of Participants Classified as Wrist Treatment Responders at Week 6 and Week 12
participantsBOTOX in Original DB Study; BOTOX in OL StudyPlacebo in Original DB Study; BOTOX in OL Study
Week 64342
Week 123539
SecondaryChange 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.

Time frame:
Baseline (Day 0), Week 6, and Week 12
Reported as:
Mean · scores on a scale
Change From Baseline at Week 6 and Week 12 for Finger Flexor Muscle Tone as Measured on the MAS
scores on a scaleBOTOX in Original DB Study; BOTOX in OL StudyPlacebo in Original DB Study; BOTOX in OL Study
Week 6-1.14 ± 0.716-1.29 ± 0.769
Week 12-0.72 ± 0.607-0.96 ± 0.805
SecondaryChange 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.

Time frame:
Baseline (Day 0), Week 6, and Week 12
Reported as:
Mean · scores on a scale
Change From Baseline at Week 6 and Week 12 for Thumb Flexor Muscle Tone as Measured on the MAS
scores on a scaleBOTOX in Original DB Study; BOTOX in OL StudyPlacebo in Original DB Study; BOTOX in OL Study
Week 6-1.02 ± 0.642-1.22 ± 0.721
Week 12-0.80 ± 0.631-0.92 ± 0.716
SecondaryChange 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.

Time frame:
Baseline (Day 0), Week 6, and Week 12
Reported as:
Mean · scores on a scale
Change From Baseline at Week 6 and Week 12 for the Principal Measure as Assessed on the Disability Assessment Scale (DAS)
scores on a scaleBOTOX in Original DB Study; BOTOX in OL StudyPlacebo in Original DB Study; BOTOX in OL Study
Week 6-0.64 ± 0.591-0.72 ± 0.662
Week 12-0.59 ± 0.570-0.57 ± 0.665
SecondaryGlobal 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.

Time frame:
Week 6 and Week 12
Reported as:
Mean · scores on a scale
Global Assessment Scale (GAS) Score as Evaluated by the Physician at Week 6 and Week 12
scores on a scaleBOTOX in Original DB Study; BOTOX in OL StudyPlacebo in Original DB Study; BOTOX in OL Study
Week 61.9 ± 0.912.2 ± 0.84
Week 121.6 ± 0.821.9 ± 0.93
SecondaryGAS 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.

Time frame:
Week 6 and Week 12
Reported as:
Mean · scores on a scale
GAS Score as Evaluated by the Care Giver or the Participant at Week 6 and Week 12
scores on a scaleBOTOX in Original DB Study; BOTOX in OL StudyPlacebo in Original DB Study; BOTOX in OL Study
Week 61.8 ± 0.912.1 ± 0.85
Week 121.6 ± 0.811.7 ± 0.91
SecondaryMean 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.

Time frame:
Baseline (Day 0) and exit visit (Week 12 or earlier)
Reported as:
Mean · 10^12 cells per Liter
Mean Change From Baseline in Red Blood Cell (RBC) Count at the Exit Visit
10^12 cells per LiterBOTOX in Original DB Study; BOTOX in OL StudyPlacebo in Original DB Study; BOTOX in OL Study
Mean Change From Baseline in Red Blood Cell (RBC) Count at the Exit Visit-0.050 ± 0.3682-0.039 ± 0.3087
SecondaryMean 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.

Time frame:
Baseline (Day 0) and the exit visit (Week 12 or earlier)
Reported as:
Mean · 10^9 cells per Liter
Mean Change From Baseline in White Blood Cell (WBC) and Platelet Count at the Exit Visit
10^9 cells per LiterBOTOX in Original DB Study; BOTOX in OL StudyPlacebo in Original DB Study; BOTOX in OL Study
WBCs0.111 ± 1.3340-0.273 ± 2.1714
Platelets-10.660 ± 38.8734-1.386 ± 41.5828
SecondaryMean 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.

Time frame:
Baseline (Day 0) and the exit visit (Week 12 or earlier)
Reported as:
Mean · Percentage of the total WBC
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
Percentage of the total WBCBOTOX in Original DB Study; BOTOX in OL StudyPlacebo in Original DB Study; BOTOX in OL Study
Neutrophils-0.009 ± 6.3905-0.757 ± 7.8585
Lymphocytes0.118 ± 6.46130.734 ± 6.7396
Monocytes-0.217 ± 1.65700.55 ± 2.7845
Eosinophils0.094 ± 1.30670.49 ± 2.3799
Basophils0.032 ± 0.29200.010 ± 0.2185
SecondaryMean 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.

Time frame:
Baseline (Day 0) and the exit visit (Week 12 or earlier)
Reported as:
Mean · Grams per Liter (grams/L)
Mean Change From Baseline in Hemoglobin Content at the Exit Visit
Grams per Liter (grams/L)BOTOX in Original DB Study; BOTOX in OL StudyPlacebo in Original DB Study; BOTOX in OL Study
Mean Change From Baseline in Hemoglobin Content at the Exit Visit-0.255 ± 10.9989-1.409 ± 8.7559
SecondaryMean 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.

Time frame:
Baseline (Day 0) and the exit visit (Week 12 or earlier)
Reported as:
Mean · percentage
Mean Change From Baseline in Hematocrit Value at the Exit Visit
percentageBOTOX in Original DB Study; BOTOX in OL StudyPlacebo in Original DB Study; BOTOX in OL Study
Mean Change From Baseline in Hematocrit Value at the Exit Visit-0.003 ± 0.0254-0.007 ± 0.0257
SecondaryMean 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.

Time frame:
Baseline (Day 0) and the exit visit (Week 12 or earlier)
Reported as:
Mean · grams/L
Mean Change From Baseline in Total Protein and Albumin Values at the Exit Visit
grams/LBOTOX in Original DB Study; BOTOX in OL StudyPlacebo in Original DB Study; BOTOX in OL Study
Total Protein-0.711 ± 5.8908-1.484 ± 6.0077
Albumin-0.400 ± 3.5067-0.236 ± 4.4753
SecondaryMean 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.

Time frame:
Baseline (Day 0) and the exit visit (Week 12 or earlier)
Reported as:
Mean · International Units per Liter (IU/L)
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
International Units per Liter (IU/L)BOTOX in Original DB Study; BOTOX in OL StudyPlacebo in Original DB Study; BOTOX in OL Study
ALT, n=47, 44-1.100 ± 10.9938-0.005 ± 13.6079
AST, n=47, 44-0.153 ± 9.3633-0.302 ± 8.2277
y-GT, n=47, 44-1.098 ± 14.00990.316 ± 17.4397
ALP, n=46, 44-3.087 ± 10.4821-4.225 ± 17.2055
SecondaryMean 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.

Time frame:
Baseline (Day 0) and the exit visit (Week 12 or earlier)
Reported as:
Mean · Micromoles per Liter (μmol/L)
Mean Change From Baseline in Serum Creatinine, Uric Acid, and Total Bilirubin Values at the Exit Visit
Micromoles per Liter (μmol/L)BOTOX in Original DB Study; BOTOX in OL StudyPlacebo in Original DB Study; BOTOX in OL Study
Creatinine-1.509 ± 9.8783-0.984 ± 20.1303
Uric Acid-3.670 ± 61.1350-16.198 ± 67.7636
Total Bilirubin0.249 ± 4.6873-0.293 ± 3.6399
SecondaryMean 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.

Time frame:
Baseline (Day 0) and the exit visit (Week 12 or earlier)
Reported as:
Mean · Millimoles per Liter (mmol/L)
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
Millimoles per Liter (mmol/L)BOTOX in Original DB Study; BOTOX in OL StudyPlacebo in Original DB Study; BOTOX in OL Study
BUN, n=47, 44-0.292 ± 1.18550.226 ± 2.9929
FBG, n=47, 430.209 ± 1.3513-0.081 ± 0.8000
Sodium, n=47, 440.423 ± 3.5990-0.034 ± 2.7857
Potassium, n=47, 44-0.008 ± 0.4014-0.060 ± 0.5128
Chloride, n=47, 441.077 ± 4.0509-0.143 ± 3.4336
Total cholesterol, n=47, 43-0.057 ± 0.84100.282 ± 0.9535
Triglycerides, n=47, 43-0.039 ± 0.65250.119 ± 0.5698
SecondaryNumber 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.

Time frame:
Screening visit (-Week 1) and the exit visit (Week 12 or earlier)
Reported as:
Number · participants
Number of Participants With Clinically Significant Abnormalities of Urinalysis at the Screening and Exit Visits
participantsBOTOX in Original DB Study; BOTOX in OL StudyPlacebo in Original DB Study; BOTOX in OL Study
Urine protein, Screening00
Urine protein, Exit visit00
Blood, Screening03
Blood, Exit visit01
Leukocytes, Screening13
Leukocytes, Exit visit10
Urine glucose, Screeing23
Urine glucose, Exit visit02
Urobilinogen, Screening00
Urobilinogen, Exit visit00
SecondaryMean 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.

Time frame:
Baseline (Day 0) and the exit visit (Week 12 or earlier)
Reported as:
Mean · Millimeters of mercury (mmHg)
Mean Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at the Exit Visit
Millimeters of mercury (mmHg)BOTOX in Original DB Study; BOTOX in OL StudyPlacebo in Original DB Study; BOTOX in OL Study
Systolic BP-3.1 ± 8.96-2.3 ± 10.02
Diastolic BP-1.4 ± 6.27-2.5 ± 7.79
SecondaryMean 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.

Time frame:
Baseline (Screening) and the exit visit (Week 12 or earlier)
Reported as:
Mean · beats per minute
Mean Change From Baseline in Pulse Rate at the Exit Visit
beats per minuteBOTOX in Original DB Study; BOTOX in OL StudyPlacebo in Original DB Study; BOTOX in OL Study
Mean Change From Baseline in Pulse Rate at the Exit Visit-3.0 ± 9.271.0 ± 8.49

Adverse events

Collected over Serious and non-serious adverse events were collected from the Screening visit (-1 Week) until the end of study visit (Week 12) or earlier, in case of early withdrawal.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
BOTOX in Original DB Study; BOTOX in OL Study—1/53 (1.9%)4/53 (7.5%)
Placebo in Original DB Study; BOTOX in OL Study—0/56 (0%)7/56 (12.5%)
Most frequent serious events
Most frequent serious events
EventBOTOX in Original DB Study; BOTOX in OL StudyPlacebo in Original DB Study; BOTOX in OL Study
Cerebral arteriovenous malformation haemorrhagicCongenital, familial and genetic disorders1/530/56
Most frequent other events
Showing 10 of 14
Most frequent other events
EventBOTOX in Original DB Study; BOTOX in OL StudyPlacebo in Original DB Study; BOTOX in OL Study
HyperlipidaemiaMetabolism and nutrition disorders2/533/56
Aspartate aminotransferase increasedInvestigations1/530/56
Blood bilirubin increasedInvestigations1/530/56
Blood glucose increasedInvestigations1/530/56
Blood potassium increasedInvestigations1/530/56
LeukopeniaBlood and lymphatic system disorders1/530/56
EpilepsyNervous system disorders1/530/56
DyslipidaemiaMetabolism and nutrition disorders0/531/56
HyperuricaemiaMetabolism and nutrition disorders0/531/56
HypokalaemiaMetabolism and nutrition disorders0/531/56

Baseline characteristics

Age, Continuous
Age, Continuous(Years)BOTOX in Original DB Study; BOTOX in OL StudyPlacebo in Original DB Study; BOTOX in OL StudyTotal
Mean54.4 ± 10.9055.4 ± 12.5354.9 ± 11.70
Gender
Gender(Participants)BOTOX in Original DB Study; BOTOX in OL StudyPlacebo in Original DB Study; BOTOX in OL StudyTotal
Female101020
Male434386
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)BOTOX in Original DB Study; BOTOX in OL StudyPlacebo in Original DB Study; BOTOX in OL StudyTotal
Chinese5353106
Number of participants with the absence or presence of thumb spasticity
Number of participants with the absence or presence of thumb spasticity(participants)BOTOX in Original DB Study; BOTOX in OL StudyPlacebo in Original DB Study; BOTOX in OL StudyTotal
Absence6612
Presence474794
08

Study locations

13 sites
  • GSK Investigational Site
    Guangzhou, Guangdong, China
  • GSK Investigational Site
    Haerbin, Heilongjiang 150001, China
  • GSK Investigational Site
    Wuhan, Hubei 430060, China
  • GSK Investigational Site
    Nanjing, Jiangsu 210029, China
  • GSK Investigational Site
    Suzhou, Jiangsu 215004, China
  • GSK Investigational Site
    Shenyang, Liaoning 110001, China
  • GSK Investigational Site
    Chengdu, Sichuan 610041, China
  • GSK Investigational Site
    Beijing, 100050, China
  • GSK Investigational Site
    Beijing, 100068, China
  • GSK Investigational Site
    Beijing, 100730, China
  • GSK Investigational Site
    Hangzhou, 310016, China
  • GSK Investigational Site
    Shanghai, 200025, China
  • GSK Investigational Site
    Shanghai, 200040, China
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2010, a primary completion of Dec 2011 and a completion of Mar 2012. It does not say whether these dates are actual or estimated.

Results were first posted in Sep 2012, 9 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 3, 2010
First posted
Sep 20, 2010
Start
Sep 2010
Primary completionActual
Dec 2011
CompletionActual
Mar 2012
Results first posted
Sep 24, 2012
Last update
Feb 28, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01205451
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Sep 20, 2010
Start date
Sep 2010
Primary completion
Dec 2011
Completion
Mar 2012
Results posted
Sep 24, 2012
Last update
Feb 28, 2017

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

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