Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
High-Dose BTX	BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
High-Dose Placebo	Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
Low-Dose BTX	BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
Low-Dose Placebo	Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
DB High-Dose BTX + OL High-Dose BTX	BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present 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 wrist >=2 and at least 12 weeks (84 days) since the last injection])
DB High-Dose Placebo + OL High-Dose BTX	Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX 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 wrist >=2 and at least 12 weeks (84 days) since the last injection])
DB Low-Dose BTX + OL High-Dose BTX	BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX 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 wrist >=2 and at least 12 weeks (84 days) since the last injection])
DB Low-Dose Placebo + OL High-Dose BTX	Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX 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 wrist >=2 and at least 12 weeks (84 days) since the last injection])

Participant Flow for 2 periods

Period 1:   Double-Blind Phase (12 Weeks)

	High-Dose BTX	High-Dose Placebo	Low-Dose BTX	Low-Dose Placebo	DB High-Dose BTX + OL High-Dose BTX	DB High-Dose Placebo + OL High-Dose BTX	DB Low-Dose BTX + OL High-Dose BTX	DB Low-Dose Placebo + OL High-Dose BTX
STARTED	51	26	21	11	0	0	0	0
COMPLETED	47	25	21	11	0	0	0	0
NOT COMPLETED	4	1	0	0	0	0	0	0
Adverse Event	3	1	0	0	0	0	0	0
Withdrawal by Subject	1	0	0	0	0	0	0	0

Period 2:   Open-Label Phase (36 Weeks)

	High-Dose BTX	High-Dose Placebo	Low-Dose BTX	Low-Dose Placebo	DB High-Dose BTX + OL High-Dose BTX	DB High-Dose Placebo + OL High-Dose BTX	DB Low-Dose BTX + OL High-Dose BTX	DB Low-Dose Placebo + OL High-Dose BTX
STARTED	0	0	0	0	47	25	21	11
COMPLETED	0	0	0	0	38	19	19	11
NOT COMPLETED	0	0	0	0	9	6	2	0
Adverse Event	0	0	0	0	3	5	2	0
Withdrawal by Subject	0	0	0	0	5	1	0	0
Concentrate on Treatment of Diabetes	0	0	0	0	1	0	0	0

Reporting Groups

	Description
High-Dose BTX	BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
High-Dose Placebo	Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
Low-Dose BTX	BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
Low-Dose Placebo	Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)

Baseline Measures

	High-Dose BTX	High-Dose Placebo	Low-Dose BTX	Low-Dose Placebo	Total
Number of Participants   [units: participants]	51	26	21	11	109
Age   [units: years] Mean ± Standard Deviation	63.5  ± 9.32	63.6  ± 11.03	62.7  ± 9.74	62.3  ± 9.61	63.2  ± 9.73
Gender   [units: participants]
Female	15	12	2	6	35
Male	36	14	19	5	74
Race/Ethnicity, Customized   [units: participants]
Asian-Japanese	51	26	21	11	109

1.  Primary:

Area Under the Curve (AUC) for the Change From Baseline in Modified Ashworth Scale (MAS) Wrist Score to the End of the DB Phase (Week 12) in the High-dose Groups   [ Time Frame: Baseline, Week 12 ]

2.  Secondary:

Area Under the Curve (AUC) for the Change From Baseline in Modified Ashworth Scale (MAS) Wrist Score to the End of the DB Phase (Week 12) in the Low-dose Groups   [ Time Frame: Baseline, Week 12 ]

3.  Secondary:

Mean Change From Baseline in MAS Wrist Score From Baseline to Week 12 of the Double-blind Phase   [ Time Frame: Baseline; Weeks 1, 4, 6, 8, and 12 ]

4.  Secondary:

Mean Change From Baseline in MAS Finger Score From Baseline to Week 12 of the Double-blind Phase   [ Time Frame: Baseline; Weeks 1, 4, 6, 8, and 12 ]

5.  Secondary:

Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Principal Measure From Baseline to Week 12 of the Double-blind Phase   [ Time Frame: Baseline; Weeks 1, 4, 6, 8, and 12 ]

6.  Secondary:

Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Hygiene From Baseline to week12 of the Double-blind Phase   [ Time Frame: Baseline; Weeks 1, 4, 6, 8, and 12 ]

7.  Secondary:

Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Pain From Baseline to Week 12 of the Double-blind Phase   [ Time Frame: Baseline; Weeks 1, 4, 6, 8, and 12 ]

8.  Secondary:

Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Dressing From Baseline to Week 12 of the Double-blind Phase   [ Time Frame: Baseline; Weeks 1, 4, 6, 8, and 12 ]

9.  Secondary:

Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Limb Posture From Baseline to Week 12 of the Double-blind Phase   [ Time Frame: Baseline; Weeks 1, 4, 6, 8, and 12 ]

10.  Secondary:

Mean Change From Baseline in Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Investigator From Baseline to Week 12 of the Double-blind Phase   [ Time Frame: Baseline; Weeks 1, 4, 6, 8, and 12 ]

11.  Secondary:

Mean Change From Baseline in Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Participant From Baseline to Week 12 of the Double-blind Phase   [ Time Frame: Baseline; Weeks 1, 4, 6, 8, and 12 ]

12.  Secondary:

Mean Change From Baseline in Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Physiotherapist/Occupational Therapist From Baseline to Week 12 of the Double-blind Phase   [ Time Frame: Baseline; Weeks 1, 4, 6, 8, and 12 ]

13.  Secondary:

Mean Change From Baseline (at the Start of the Double-blind Phase) in the MAS Wrist Score at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase   [ Time Frame: Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36) ]

14.  Secondary:

Mean Change From Baseline (at the Start of the Double-blind Phase) in the MAS Finger Score From at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase   [ Time Frame: Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36) ]

15.  Secondary:

Mean Change From Baseline (at the Start of the Double-blind Phase) in the Disability Assessment Scale (DAS) Score of Principal Measure at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase   [ Time Frame: Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36) ]

16.  Secondary:

Mean Change From Baseline (at the Start of the Double-blind Phase) in the Disability Assessment Scale (DAS) Score of Hygiene at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase   [ Time Frame: Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36) ]

17.  Secondary:

Mean Change From Baseline (at the Start of the Double-blind Phase) in the Disability Assessment Scale (DAS) Score of Pain at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase   [ Time Frame: Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36) ]

18.  Secondary:

Mean Change From Baseline (at the Start of the Double-blind Phase) in the Disability Assessment Scale (DAS) Score of Dressing at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase   [ Time Frame: Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36) ]

19.  Secondary:

Mean Change From Baseline (at the Start of the Double-blind Phase) in the Disability Assessment Scale (DAS) Score of Limb Posture at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase   [ Time Frame: Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36) ]

20.  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   [ Time Frame: Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36) ]

21.  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   [ Time Frame: Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36) ]

22.  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   [ Time Frame: Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36) ]