| Primary | 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. | Full Analysis Set (FAS) Population: all randomized and treated participants with at least one post-treatment MAS wrist score. The missing data imputation method was used for analysis. For each participant, missing data points were replaced by the mean of the non-missing scores from both treatment groups for that variable at the specific visit. | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline (Day 0), Week 6, and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | BOTOX in Original DB Study; BOTOX in OL Study | Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). | | OG001 | Placebo in Original DB Study; BOTOX in OL Study | Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). |
| | | Title | Denominators | Categories |
|---|
| Week 6 | | | Title | Measurements |
|---|
| - OG000-1.21± 0.616
- OG001-1.33± 0.753
|
| | Week 12 | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Wilcoxon signed-rank test | | <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 | | | 2-Sided | 95 | -1.38 | -1.04 | | | Confidence intervals for means were based on the t-distribution. | No | Superiority or Other | | | | |
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| Secondary | 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). | FAS Population. The missing data imputation method was used for analysis. | Posted | | Number | | participants | | Baseline (Day 0), Week 6, and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | BOTOX in Original DB Study; BOTOX in OL Study | Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). | | OG001 | Placebo in Original DB Study; BOTOX in OL Study | Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). |
|
| Secondary | 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. | FAS Population. The missing data imputation method was used for analysis. | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline (Day 0), Week 6, and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | BOTOX in Original DB Study; BOTOX in OL Study | Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). | | OG001 | Placebo in Original DB Study; BOTOX in OL Study | Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). |
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| Secondary | 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. | FAS Population. Only those participants who had thumb spasticity were analyzed. The missing data imputation method was used for analysis. | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline (Day 0), Week 6, and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | BOTOX in Original DB Study; BOTOX in OL Study | Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). | | OG001 | Placebo in Original DB Study; BOTOX in OL Study | Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). |
|
| Secondary | 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. | FAS Population. The missing data imputation method was used for analysis. | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline (Day 0), Week 6, and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | BOTOX in Original DB Study; BOTOX in OL Study | Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). | | OG001 | Placebo in Original DB Study; BOTOX in OL Study | Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). |
|
| Secondary | 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. | FAS Population. The missing data imputation method was used for analysis. | Posted | | Mean | Standard Deviation | scores on a scale | | Week 6 and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | BOTOX in Original DB Study; BOTOX in OL Study | Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). | | OG001 | Placebo in Original DB Study; BOTOX in OL Study | Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). |
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| Secondary | 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. | FAS Population. The missing data imputation method was used for analysis. | Posted | | Mean | Standard Deviation | scores on a scale | | Week 6 and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | BOTOX in Original DB Study; BOTOX in OL Study | Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). | | OG001 | Placebo in Original DB Study; BOTOX in OL Study | Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). |
|
| Secondary | 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. | Safety Set Population: all enrolled and treated participants. Only those participants for whom data were available for both the Baseline and exit visits were analyzed. | Posted | | Mean | Standard Deviation | 10^12 cells per Liter | | Baseline (Day 0) and exit visit (Week 12 or earlier) | | | | ID | Title | Description |
|---|
| OG000 | BOTOX in Original DB Study; BOTOX in OL Study | Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). | | OG001 | Placebo in Original DB Study; BOTOX in OL Study | Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). |
|
| Secondary | 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. | Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed. | Posted | | Mean | Standard Deviation | 10^9 cells per Liter | | Baseline (Day 0) and the exit visit (Week 12 or earlier) | | | | ID | Title | Description |
|---|
| OG000 | BOTOX in Original DB Study; BOTOX in OL Study | Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). | | OG001 | Placebo in Original DB Study; BOTOX in OL Study | Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). |
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| Secondary | 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. | Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed. | Posted | | Mean | Standard Deviation | Percentage of the total WBC | | Baseline (Day 0) and the exit visit (Week 12 or earlier) | | | | ID | Title | Description |
|---|
| OG000 | BOTOX in Original DB Study; BOTOX in OL Study | Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). | | OG001 | Placebo in Original DB Study; BOTOX in OL Study | Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). |
|
| Secondary | 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. | Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed. | Posted | | Mean | Standard Deviation | Grams per Liter (grams/L) | | Baseline (Day 0) and the exit visit (Week 12 or earlier) | | | | ID | Title | Description |
|---|
| OG000 | BOTOX in Original DB Study; BOTOX in OL Study | Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). | | OG001 | Placebo in Original DB Study; BOTOX in OL Study | Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). |
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| Secondary | 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. | Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed. | Posted | | Mean | Standard Deviation | percentage | | Baseline (Day 0) and the exit visit (Week 12 or earlier) | | | | ID | Title | Description |
|---|
| OG000 | BOTOX in Original DB Study; BOTOX in OL Study | Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). | | OG001 | Placebo in Original DB Study; BOTOX in OL Study | Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). |
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| Secondary | 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. | Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed. | Posted | | Mean | Standard Deviation | grams/L | | Baseline (Day 0) and the exit visit (Week 12 or earlier) | | | | ID | Title | Description |
|---|
| OG000 | BOTOX in Original DB Study; BOTOX in OL Study | Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). | | OG001 | Placebo in Original DB Study; BOTOX in OL Study | Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). |
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| Secondary | 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. | Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed. | Posted | | Mean | Standard Deviation | International Units per Liter (IU/L) | | Baseline (Day 0) and the exit visit (Week 12 or earlier) | | | | ID | Title | Description |
|---|
| OG000 | BOTOX in Original DB Study; BOTOX in OL Study | Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). | | OG001 | Placebo in Original DB Study; BOTOX in OL Study | Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). |
|
| Secondary | 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. | Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed. | Posted | | Mean | Standard Deviation | Micromoles per Liter (μmol/L) | | Baseline (Day 0) and the exit visit (Week 12 or earlier) | | | | ID | Title | Description |
|---|
| OG000 | BOTOX in Original DB Study; BOTOX in OL Study | Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). | | OG001 | Placebo in Original DB Study; BOTOX in OL Study | Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). |
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| Secondary | 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. | Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed. | Posted | | Mean | Standard Deviation | Millimoles per Liter (mmol/L) | | Baseline (Day 0) and the exit visit (Week 12 or earlier) | | | | ID | Title | Description |
|---|
| OG000 | BOTOX in Original DB Study; BOTOX in OL Study | Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). | | OG001 | Placebo in Original DB Study; BOTOX in OL Study | Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). |
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| Secondary | 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. | Safety Set Population. Only those participants for whom data were available for both the Screening and exit visits were analyzed. | Posted | | Number | | participants | | Screening visit (-Week 1) and the exit visit (Week 12 or earlier) | | | | ID | Title | Description |
|---|
| OG000 | BOTOX in Original DB Study; BOTOX in OL Study | Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). | | OG001 | Placebo in Original DB Study; BOTOX in OL Study | Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). |
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| Secondary | 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. | Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed. | Posted | | Mean | Standard Deviation | Millimeters of mercury (mmHg) | | Baseline (Day 0) and the exit visit (Week 12 or earlier) | | | | ID | Title | Description |
|---|
| OG000 | BOTOX in Original DB Study; BOTOX in OL Study | Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). | | OG001 | Placebo in Original DB Study; BOTOX in OL Study | Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). |
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| Secondary | 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. | Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed. | Posted | | Mean | Standard Deviation | beats per minute | | Baseline (Screening) and the exit visit (Week 12 or earlier) | | | | ID | Title | Description |
|---|
| OG000 | BOTOX in Original DB Study; BOTOX in OL Study | Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). | | OG001 | Placebo in Original DB Study; BOTOX in OL Study | Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0). |
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