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This is a study to confirm the superior efficacy of GSK1358820 over placebo in patients with equinus deformity associated with post-stroke lower limb spasticity using the Modified Ashworth Scale (MAS) ankle score.
This is a study to confirm the superior efficacy of GSK1358820 over placebo in patients with equinus deformity associated with post-stroke lower limb spasticity using the Modified Ashworth Scale (MAS) ankle score.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BTX | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK1358820 | Drug | botulinum toxin type A |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (AUC) for the Change From Baseline in Modified Ashworth Scale (MAS) Ankle Score to the End of the DB Phase (Week 12) | Change from baseline in MAS ankle score using a 6-point scale (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) to each time point in the DB phase was calculated. In the graph plotting time points on the horizontal axis and changes from baseline on the vertical axis, the area surrounded by the MAS ankle score change curve and the horizontal axis was calculated and used as a summary index (AUC) for assessment of the MAS ankle score. Negative changes from baseline indicate improvement, and the AUC has a negative sign. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in the MAS Ankle Score From Baseline to Week 12 of the Double-blind Phase | The investigator assessed Modified Ashworth Scale (MAS) ankle score using a 6-point scale (0, 1, 1+, 2, 3, and 4; 0=No increase in muscle tone to 4=Affected part[s] rigid in flexion or extension) at each time point in the double-blind phase. The "+1" (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder [less than half] of ROM [range of motion]) of MAS score is regarded as score 1.5. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Fukuoka | 811-0213 | Japan | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20358216 | Derived | Kaji R, Osako Y, Suyama K, Maeda T, Uechi Y, Iwasaki M; GSK1358820 Spasticity Study Group. Botulinum toxin type A in post-stroke lower limb spasticity: a multicenter, double-blind, placebo-controlled trial. J Neurol. 2010 Aug;257(8):1330-7. doi: 10.1007/s00415-010-5526-3. Epub 2010 Apr 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | BTX 300U | BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) |
| FG001 | Placebo | Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) |
| FG002 | DB BTX + OL BTX | BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection]) |
| FG003 | DB Placebo + OL BTX | Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus BTX (GSK1358820) 300U in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection]) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Double-Blind Phase (12 Weeks) |
|
| ||||||||||||||||||
| Open-Label Phase (36 Weeks) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BTX 300U | BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) |
| BG001 | Placebo | Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Curve (AUC) for the Change From Baseline in Modified Ashworth Scale (MAS) Ankle Score to the End of the DB Phase (Week 12) | Change from baseline in MAS ankle score using a 6-point scale (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) to each time point in the DB phase was calculated. In the graph plotting time points on the horizontal axis and changes from baseline on the vertical axis, the area surrounded by the MAS ankle score change curve and the horizontal axis was calculated and used as a summary index (AUC) for assessment of the MAS ankle score. Negative changes from baseline indicate improvement, and the AUC has a negative sign. | Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score | Posted | Mean | Standard Deviation | Score*week | Baseline, Week 12 |
|
Adverse Events (AEs) were classified by onset time because the study consists of the double-blind (DB) and open-label (OL) phases.
AEs in the double-blind (DB) phase (Arms 1-2), AEs occurring after the start (injection) of the DB phase (Week 0), but before the first injection day in the open-label (OL) phase; AEs in the OL phase (Arms 3-4), AEs occurring after the first injection day in the OL phase. SAEs and AEs were analyzed in the Full Analysis Set.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BTX 300U | BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Placebo |
|
| Baseline; Weeks 1, 4, 6, 8, and 12 |
| Mean Change From Baseline in the Physician's Rating Score (PRS) From Baseline to Week 12 of the Double-blind Phase | The investigator assessed the PRS of gait pattern consisting of 3 parameters. Affected limb was scored on a scale of -1 (worst) to 9 (best) based on 3 parameters (initial foot contact, foot contact at midstance, gait assistive devices) at each time point in double-blind phase. | Baseline; Weeks 1, 4, 6, 8, and 12 |
| Mean Change From Baseline in the Time (Seconds) to Walk 10 Meters From Baseline to Week 12 of the Double-blind Phase | The time (seconds) required to walk 10 meters was measured at each time point in the double-blind phase. | Baseline; Weeks 1, 4, 6, 8, and 12 |
| Mean Change From Baseline in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Investigator From Baseline to Week 12 of the Double-blind Phase | The CGI of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point in the double-blind phase. | Baseline; Weeks 1, 4, 6, 8, and 12 |
| Mean Change From Baseline in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Participant From Baseline to Week 12 of the Double-blind Phase | The CGI of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point in the double-blind phase | Baseline; Weeks 1, 4, 6, 8, and 12 |
| Mean Change From Baseline in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Physiotherapist/Occupational Therapist From Baseline to Week 12 of the Double-blind Phase | The CGI of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point in the double-blind phase | Baseline; Weeks 1, 4, 6, 8, and 12 |
| Mean Change From Baseline (at the Start of the Double-blind Phase) in the MAS Ankle Score at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase | The investigator assessed Modified Ashworth Scale (MAS) ankle score using a 6-point scale (0, 1, 1+, 2, 3, and 4; 0=No increase in muscle tone to 4=Affected part[s] rigid in flexion or extension) at each time point from baseline (at the start of the double-blind phase) to Week 48. The "+1" (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder [less than half] of ROM [range of motion]) of MAS score is regarded as score 1.5. | Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36) |
| Mean Change From Baseline (at the Start of the Double-blind Phase) in the Physician's Rating Score (PRS) at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase | The investigator assessed the PRS of gait pattern consisting of 3 parameters. Affected limb was scored on a scale of -1 (worst) to 9 (best) based on 3 parameters (initial foot contact, foot contact at midstance, gait assistive devices) at each time point from baseline (at the start of the double-blind phase) to Week 48. | Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36) |
| Mean Change From Baseline (at the Start of the Double-blind Phase) in the Time (Seconds) to Walk 10 Meters at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase | The time (seconds) required to walk 10 meters was measured at each time point from baseline (at the start of the double-blind phase) to Week 48. | Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36) |
| Mean Change From Baseline (at the Start of the Double-blind Phase) in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Investigator at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase | The CGI of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point from baseline (at the start of the double-blind phase) to Week 48. | Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36) |
| Mean Change From Baseline (at the Start of the Double-blind Phase) in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Participant at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase | The CGI of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point from baseline (at the start of the double-blind phase) to Week 48. | Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36) |
| Mean Change From Baseline (at the Start of the DB Phase) in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Physiotherapist/Occupational Therapist at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase | The CGI of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point from baseline (at the start of the double-blind phase) to Week 48. | Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36) |
| Hiroshima |
| 720-0825 |
| Japan |
| GSK Investigational Site | Hiroshima | 728-0001 | Japan |
| GSK Investigational Site | Hokkaido | 005-0802 | Japan |
| GSK Investigational Site | Hokkaido | 005-8555 | Japan |
| GSK Investigational Site | Hokkaido | 006-0805 | Japan |
| GSK Investigational Site | Hokkaido | 053-0803 | Japan |
| GSK Investigational Site | Ibaraki | 302-0112 | Japan |
| GSK Investigational Site | Kanagawa | 227-8518 | Japan |
| GSK Investigational Site | Kanagawa | 247-8533 | Japan |
| GSK Investigational Site | Kanagawa | 253-8558 | Japan |
| GSK Investigational Site | Kanagawa | 257-0001 | Japan |
| GSK Investigational Site | Kumamoto | 860-8518 | Japan |
| GSK Investigational Site | Shizuoka | 410-1128 | Japan |
| GSK Investigational Site | Shizuoka | 410-2507 | Japan |
| GSK Investigational Site | Shizuoka | 410-3293 | Japan |
| GSK Investigational Site | Tokyo | 105-8471 | Japan |
| GSK Investigational Site | Tokyo | 140-0001 | Japan |
| GSK Investigational Site | Tokyo | 142-8666 | Japan |
| GSK Investigational Site | Yamaguchi | 740-0021 | Japan |
| Withdrawal by Subject |
|
| Protocol Violation |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| BTX 300U |
BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) |
| OG001 | Placebo | Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) |
|
|
|
| Secondary | Mean Change From Baseline in the MAS Ankle Score From Baseline to Week 12 of the Double-blind Phase | The investigator assessed Modified Ashworth Scale (MAS) ankle score using a 6-point scale (0, 1, 1+, 2, 3, and 4; 0=No increase in muscle tone to 4=Affected part[s] rigid in flexion or extension) at each time point in the double-blind phase. The "+1" (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder [less than half] of ROM [range of motion]) of MAS score is regarded as score 1.5. | Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score | Posted | Mean | Standard Deviation | Points on a scale | Baseline; Weeks 1, 4, 6, 8, and 12 |
|
|
|
| Secondary | Mean Change From Baseline in the Physician's Rating Score (PRS) From Baseline to Week 12 of the Double-blind Phase | The investigator assessed the PRS of gait pattern consisting of 3 parameters. Affected limb was scored on a scale of -1 (worst) to 9 (best) based on 3 parameters (initial foot contact, foot contact at midstance, gait assistive devices) at each time point in double-blind phase. | Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score | Posted | Mean | Standard Deviation | Points on a scale | Baseline; Weeks 1, 4, 6, 8, and 12 |
|
|
|
| Secondary | Mean Change From Baseline in the Time (Seconds) to Walk 10 Meters From Baseline to Week 12 of the Double-blind Phase | The time (seconds) required to walk 10 meters was measured at each time point in the double-blind phase. | Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score | Posted | Mean | Standard Deviation | seconds | Baseline; Weeks 1, 4, 6, 8, and 12 |
|
|
|
| Secondary | Mean Change From Baseline in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Investigator From Baseline to Week 12 of the Double-blind Phase | The CGI of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point in the double-blind phase. | Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score | Posted | Mean | Standard Deviation | Points on a scale | Baseline; Weeks 1, 4, 6, 8, and 12 |
|
|
|
| Secondary | Mean Change From Baseline in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Participant From Baseline to Week 12 of the Double-blind Phase | The CGI of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point in the double-blind phase | Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score | Posted | Mean | Standard Deviation | Points on a scale | Baseline; Weeks 1, 4, 6, 8, and 12 |
|
|
|
| Secondary | Mean Change From Baseline in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Physiotherapist/Occupational Therapist From Baseline to Week 12 of the Double-blind Phase | The CGI of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point in the double-blind phase | Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score | Posted | Mean | Standard Deviation | Points on a scale | Baseline; Weeks 1, 4, 6, 8, and 12 |
|
|
|
| Secondary | Mean Change From Baseline (at the Start of the Double-blind Phase) in the MAS Ankle Score at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase | The investigator assessed Modified Ashworth Scale (MAS) ankle score using a 6-point scale (0, 1, 1+, 2, 3, and 4; 0=No increase in muscle tone to 4=Affected part[s] rigid in flexion or extension) at each time point from baseline (at the start of the double-blind phase) to Week 48. The "+1" (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder [less than half] of ROM [range of motion]) of MAS score is regarded as score 1.5. | Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score | Posted | Mean | Standard Deviation | Points on a scale | Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36) |
|
|
|
| Secondary | Mean Change From Baseline (at the Start of the Double-blind Phase) in the Physician's Rating Score (PRS) at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase | The investigator assessed the PRS of gait pattern consisting of 3 parameters. Affected limb was scored on a scale of -1 (worst) to 9 (best) based on 3 parameters (initial foot contact, foot contact at midstance, gait assistive devices) at each time point from baseline (at the start of the double-blind phase) to Week 48. | Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score | Posted | Mean | Standard Deviation | Points on a scale | Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36) |
|
|
|
| Secondary | Mean Change From Baseline (at the Start of the Double-blind Phase) in the Time (Seconds) to Walk 10 Meters at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase | The time (seconds) required to walk 10 meters was measured at each time point from baseline (at the start of the double-blind phase) to Week 48. | Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score | Posted | Mean | Standard Deviation | seconds | Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36) |
|
|
|
| Secondary | Mean Change From Baseline (at the Start of the Double-blind Phase) in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Investigator at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase | The CGI of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point from baseline (at the start of the double-blind phase) to Week 48. | Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score | Posted | Mean | Standard Deviation | Points on a scale | Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36) |
|
|
|
| Secondary | Mean Change From Baseline (at the Start of the Double-blind Phase) in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Participant at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase | The CGI of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point from baseline (at the start of the double-blind phase) to Week 48. | Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score | Posted | Mean | Standard Deviation | Points on a scale | Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36) |
|
|
|
| Secondary | Mean Change From Baseline (at the Start of the DB Phase) in the Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Physiotherapist/Occupational Therapist at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase | The CGI of functional disability was assessed at each visit using the 11-point Numeric Rating Scale (NRS) (-5=Worst Possible to 5=Best Possible) at each time point from baseline (at the start of the double-blind phase) to Week 48. | Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score | Posted | Mean | Standard Deviation | Points on a scale | Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36) |
|
|
|
| 5 |
| 58 |
| 16 |
| 58 |
| EG001 | Placebo | Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) | 1 | 62 | 16 | 62 |
| EG002 | DB BTX + OL BTX | BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection]) | 3 | 50 | 23 | 50 |
| EG003 | DB Placebo + OL BTX | Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus BTX (GSK1358820) 300U in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection]) | 8 | 57 | 16 | 57 |
| Gastric ulcer hemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Mania | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastric polyps | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Calculus ureteric | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA | Systematic Assessment |
|
| Tinea pedis | Infections and infestations | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Muscle spasm | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Week 6 |
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| Week 8 |
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| Week 12 |
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| Week 6 |
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| Week 8 |
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| Week 12 |
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| Week 6 |
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| Week 8 |
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| Week 12 |
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| Week 6 |
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| Week 8 |
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| Week 12 |
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| Week 6 |
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| Week 8 |
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| Week 12 |
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| Week 6 |
|
| Week 8 |
|
| Week 12 |
|
| Week 12 after first injection in OL |
|
| Week 4 after second injection in OL |
|
| Week 8 after second injection in OL |
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| Week 12 after second injection in OL |
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| Week 4 after third injection in OL |
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| Week 8 after third injection in OL |
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| Week 12 after third injection in OL |
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| Week 12 after first injection in OL |
|
| Week 4 after second injection in OL |
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| Week 8 after second injection in OL |
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| Week 12 after second injection in OL |
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| Week 4 after third injection in OL |
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| Week 8 after third injection in OL |
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| Week 12 after third injection in OL |
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| Week 12 after first injection in OL |
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| Week 4 after second injection in OL |
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| Week 8 after second injection in OL |
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| Week 12 after second injection in OL |
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| Week 4 after third injection in OL |
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| Week 8 after third injection in OL |
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| Week 12 after third injection in OL |
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| Week 12 after first injection in OL |
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| Week 4 after second injection in OL |
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| Week 8 after second injection in OL |
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| Week 12 after second injection in OL |
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| Week 4 after third injection in OL |
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| Week 8 after third injection in OL |
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| Week 12 after third injection in OL |
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| Week 12 after first injection in OL |
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| Week 4 after second injection in OL |
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| Week 8 after second injection in OL |
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| Week 12 after second injection in OL |
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| Week 4 after third injection in OL |
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| Week 8 after third injection in OL |
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| Week 12 after third injection in OL |
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| Week 12 after first injection in OL |
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| Week 4 after second injection in OL |
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| Week 8 after second injection in OL |
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| Week 12 after second injection in OL |
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| Week 4 after third injection in OL |
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| Week 8 after third injection in OL |
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| Week 12 after third injection in OL |
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