Trial Outcomes & Findings for Study Of GSK1358820 In Patients With Post-Stroke Upper Limb Spasticity (NCT NCT00460564)

Last Updated: 2017-05-30

Results Overview

Change from baseline in MAS wrist 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 wrist score change curve and the horizontal axis was calculated and used as a summary index (AUC) for assessment of the MAS wrist score. Negative changes from baseline indicate improvement, and the AUC has a negative sign.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

109 participants

Primary outcome timeframe

Baseline, Week 12

Results posted on

2017-05-30

Participant Flow

Participant milestones

Participant milestones
Measure	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 \[Modified Ashworth Scale (MAS) score of wrist \>=2 and at least 12 weeks (84 days) since the last injection\])
Double-Blind Phase (12 Weeks) STARTED	51	26	21	11	0	0	0	0
Double-Blind Phase (12 Weeks) COMPLETED	47	25	21	11	0	0	0	0
Double-Blind Phase (12 Weeks) NOT COMPLETED	4	1	0	0	0	0	0	0
Open-Label Phase (36 Weeks) STARTED	0	0	0	0	47	25	21	11
Open-Label Phase (36 Weeks) COMPLETED	0	0	0	0	38	19	19	11
Open-Label Phase (36 Weeks) NOT COMPLETED	0	0	0	0	9	6	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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)	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 \[Modified Ashworth Scale (MAS) score of wrist \>=2 and at least 12 weeks (84 days) since the last injection\])
Double-Blind Phase (12 Weeks) Adverse Event	3	1	0	0	0
Double-Blind Phase (12 Weeks) Withdrawal by Subject	1	0	0	0	0
Open-Label Phase (36 Weeks) Adverse Event	0	0	3	5	2
Open-Label Phase (36 Weeks) Withdrawal by Subject	0	0	5	1	0
Open-Label Phase (36 Weeks) Concentrate on Treatment of Diabetes	0	0	1	0	0

Baseline Characteristics

Study Of GSK1358820 In Patients With Post-Stroke Upper Limb Spasticity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High-Dose BTX n=51 Participants 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 n=26 Participants 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 n=21 Participants 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 n=11 Participants 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)	Total n=109 Participants Total of all reporting groups
Age, Continuous	63.5 years STANDARD_DEVIATION 9.32 • n=5 Participants	63.6 years STANDARD_DEVIATION 11.03 • n=7 Participants	62.7 years STANDARD_DEVIATION 9.74 • n=5 Participants	62.3 years STANDARD_DEVIATION 9.61 • n=4 Participants	63.2 years STANDARD_DEVIATION 9.73 • n=21 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	12 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants	35 Participants n=21 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	14 Participants n=7 Participants	19 Participants n=5 Participants	5 Participants n=4 Participants	74 Participants n=21 Participants
Race/Ethnicity, Customized Asian-Japanese	51 participants n=5 Participants	26 participants n=7 Participants	21 participants n=5 Participants	11 participants n=4 Participants	109 participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: 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 wrist score

Outcome measures

Outcome measures
Measure	High-Dose BTX n=51 Participants 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 n=26 Participants 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)
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	-10.397 Score*week Standard Deviation 8.9313	-3.567 Score*week Standard Deviation 4.7189	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Change from baseline in MAS wrist 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 (HA) and changes from baseline on the vertical axis, the area surrounded by the MAS wrist score change curve and the HA was calculated and used as a summary index (AUC) for assessment of the MAS wrist score. Negative changes from baseline indicate improvement, and the area under the AUC has a negative sign.

Outcome measures

Outcome measures
Measure	High-Dose BTX n=21 Participants 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 n=11 Participants 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)
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	-10.036 Score*week Standard Deviation 7.7743	-6.227 Score*week Standard Deviation 8.6584	—	—

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 4, 6, 8, and 12

The investigator assessed MAS wrist 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.

Outcome measures

Outcome measures
Measure	High-Dose BTX n=51 Participants 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 n=26 Participants 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 n=21 Participants 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 n=11 Participants 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)
Mean Change From Baseline in MAS Wrist Score From Baseline to Week 12 of the Double-blind Phase Week 1	-0.66 Points on a scale Standard Deviation 0.745	-0.23 Points on a scale Standard Deviation 0.430	-0.86 Points on a scale Standard Deviation 0.777	-0.50 Points on a scale Standard Deviation 0.742
Mean Change From Baseline in MAS Wrist Score From Baseline to Week 12 of the Double-blind Phase Week 4	-1.05 Points on a scale Standard Deviation 0.912	-0.48 Points on a scale Standard Deviation 0.671	-0.88 Points on a scale Standard Deviation 0.740	-0.73 Points on a scale Standard Deviation 1.009
Mean Change From Baseline in MAS Wrist Score From Baseline to Week 12 of the Double-blind Phase Week 6	-1.15 Points on a scale Standard Deviation 0.931	-0.29 Points on a scale Standard Deviation 0.569	-0.95 Points on a scale Standard Deviation 0.789	-0.68 Points on a scale Standard Deviation 0.956
Mean Change From Baseline in MAS Wrist Score From Baseline to Week 12 of the Double-blind Phase Week 8	-1.01 Points on a scale Standard Deviation 0.970	-0.35 Points on a scale Standard Deviation 0.599	-0.93 Points on a scale Standard Deviation 0.884	-0.50 Points on a scale Standard Deviation 0.742
Mean Change From Baseline in MAS Wrist Score From Baseline to Week 12 of the Double-blind Phase Week 12	-0.83 Points on a scale Standard Deviation 0.842	-0.20 Points on a scale Standard Deviation 0.408	-0.71 Points on a scale Standard Deviation 0.845	-0.27 Points on a scale Standard Deviation 0.647

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 4, 6, 8, and 12

The investigator assessed MAS finger 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.

Outcome measures

Outcome measures
Measure	High-Dose BTX n=51 Participants 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 n=26 Participants 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 n=21 Participants 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 n=11 Participants 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)
Mean Change From Baseline in MAS Finger Score From Baseline to Week 12 of the Double-blind Phase Week 1	-0.60 Points on a scale Standard Deviation 0.671	-0.19 Points on a scale Standard Deviation 0.402	-0.69 Points on a scale Standard Deviation 0.733	-0.23 Points on a scale Standard Deviation 0.684
Mean Change From Baseline in MAS Finger Score From Baseline to Week 12 of the Double-blind Phase Week 4	-0.92 Points on a scale Standard Deviation 0.821	-0.37 Points on a scale Standard Deviation 0.657	-0.95 Points on a scale Standard Deviation 0.757	-0.55 Points on a scale Standard Deviation 0.688
Mean Change From Baseline in MAS Finger Score From Baseline to Week 12 of the Double-blind Phase Week 6	-0.97 Points on a scale Standard Deviation 0.800	-0.33 Points on a scale Standard Deviation 0.734	-0.98 Points on a scale Standard Deviation 0.782	-0.23 Points on a scale Standard Deviation 0.684
Mean Change From Baseline in MAS Finger Score From Baseline to Week 12 of the Double-blind Phase Week 8	-0.86 Points on a scale Standard Deviation 0.790	-0.35 Points on a scale Standard Deviation 0.759	-0.69 Points on a scale Standard Deviation 0.750	-0.27 Points on a scale Standard Deviation 0.518
Mean Change From Baseline in MAS Finger Score From Baseline to Week 12 of the Double-blind Phase Week 12	-0.67 Points on a scale Standard Deviation 0.709	-0.26 Points on a scale Standard Deviation 0.597	-0.45 Points on a scale Standard Deviation 0.947	-0.14 Points on a scale Standard Deviation 0.323

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 4, 6, 8, and 12

DAS scores of Hygiene, Pain, Dressing, and Limb posture were assessed using a 4-point scale (0=No functional disability to 3=Severe disability). Prior to the first injection, the investigator, in consultation with the participant, selected one functional disability item and assessed it as a principal measure at each time point in the double-blind phase.

Outcome measures

Outcome measures
Measure	High-Dose BTX n=51 Participants 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 n=26 Participants 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 n=21 Participants 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 n=11 Participants 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)
Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Principal Measure From Baseline to Week 12 of the Double-blind Phase Week 1	-0.49 Points on a scale Standard Deviation 0.612	-0.15 Points on a scale Standard Deviation 0.368	-0.67 Points on a scale Standard Deviation 0.658	0.00 Points on a scale Standard Deviation 0.000
Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Principal Measure From Baseline to Week 12 of the Double-blind Phase Week 4	-0.82 Points on a scale Standard Deviation 0.748	-0.31 Points on a scale Standard Deviation 0.618	-0.67 Points on a scale Standard Deviation 0.577	0.00 Points on a scale Standard Deviation 0.000
Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Principal Measure From Baseline to Week 12 of the Double-blind Phase Week 6	-0.86 Points on a scale Standard Deviation 0.764	-0.35 Points on a scale Standard Deviation 0.629	-0.67 Points on a scale Standard Deviation 0.577	-0.09 Points on a scale Standard Deviation 0.302
Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Principal Measure From Baseline to Week 12 of the Double-blind Phase Week 8	-0.79 Points on a scale Standard Deviation 0.771	-0.38 Points on a scale Standard Deviation 0.647	-0.71 Points on a scale Standard Deviation 0.561	0.00 Points on a scale Standard Deviation 0.447
Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Principal Measure From Baseline to Week 12 of the Double-blind Phase Week 12	-0.70 Points on a scale Standard Deviation 0.689	-0.32 Points on a scale Standard Deviation 0.557	-0.57 Points on a scale Standard Deviation 0.598	0.09 Points on a scale Standard Deviation 0.302

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 4, 6, 8, and 12

DAS score of Hygiene was assessed using a 4-point scale (0=No functional disability to 3=Severe disability) at each time point in double-blind phase.

Outcome measures

Outcome measures
Measure	High-Dose BTX n=51 Participants 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 n=26 Participants 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 n=21 Participants 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 n=11 Participants 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)
Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Hygiene From Baseline to week12 of the Double-blind Phase Week 1	-0.27 Points on a scale Standard Deviation 0.532	-0.12 Points on a scale Standard Deviation 0.431	-0.43 Points on a scale Standard Deviation 0.746	-0.18 Points on a scale Standard Deviation 0.405
Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Hygiene From Baseline to week12 of the Double-blind Phase Week 4	-0.39 Points on a scale Standard Deviation 0.603	-0.23 Points on a scale Standard Deviation 0.587	-0.38 Points on a scale Standard Deviation 0.669	-0.36 Points on a scale Standard Deviation 0.674
Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Hygiene From Baseline to week12 of the Double-blind Phase Week 6	-0.43 Points on a scale Standard Deviation 0.612	-0.31 Points on a scale Standard Deviation 0.618	-0.43 Points on a scale Standard Deviation 0.746	-0.27 Points on a scale Standard Deviation 0.467
Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Hygiene From Baseline to week12 of the Double-blind Phase Week 8	-0.40 Points on a scale Standard Deviation 0.676	-0.29 Points on a scale Standard Deviation 0.624	-0.43 Points on a scale Standard Deviation 0.746	-0.18 Points on a scale Standard Deviation 0.405
Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Hygiene From Baseline to week12 of the Double-blind Phase Week 12	-0.34 Points on a scale Standard Deviation 0.600	-0.28 Points on a scale Standard Deviation 0.678	-0.33 Points on a scale Standard Deviation 0.658	-0.09 Points on a scale Standard Deviation 0.539

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 4, 6, 8, and 12

DAS score of pain was assessed using a 4-point scale (0=No functional disability to 3=Severe disability) at each time point in the double-blind phase.

Outcome measures

Outcome measures
Measure	High-Dose BTX n=51 Participants 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 n=26 Participants 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 n=21 Participants 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 n=11 Participants 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)
Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Pain From Baseline to Week 12 of the Double-blind Phase Week 1	-0.10 Points on a scale Standard Deviation 0.608	0.04 Points on a scale Standard Deviation 0.344	-0.14 Points on a scale Standard Deviation 0.359	0.00 Points on a scale Standard Deviation 0.000
Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Pain From Baseline to Week 12 of the Double-blind Phase Week 4	-0.20 Points on a scale Standard Deviation 0.749	0.04 Points on a scale Standard Deviation 0.445	-0.10 Points on a scale Standard Deviation 0.436	0.00 Points on a scale Standard Deviation 0.000
Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Pain From Baseline to Week 12 of the Double-blind Phase Week 6	-0.20 Points on a scale Standard Deviation 0.676	-0.12 Points on a scale Standard Deviation 0.588	-0.10 Points on a scale Standard Deviation 0.436	-0.09 Points on a scale Standard Deviation 0.302
Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Pain From Baseline to Week 12 of the Double-blind Phase Week 8	-0.19 Points on a scale Standard Deviation 0.673	-0.04 Points on a scale Standard Deviation 0.751	-0.14 Points on a scale Standard Deviation 0.478	-0.09 Points on a scale Standard Deviation 0.302
Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Pain From Baseline to Week 12 of the Double-blind Phase Week 12	-0.09 Points on a scale Standard Deviation 0.747	0.00 Points on a scale Standard Deviation 0.645	-0.14 Points on a scale Standard Deviation 0.359	-0.18 Points on a scale Standard Deviation 0.405

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 4, 6, 8, and 12

DAS score of Dressing was assessed using a 4-point scale (0=No functional disability to 3=Severe disability) at each time point in the double-blind phase.

Outcome measures

Outcome measures
Measure	High-Dose BTX n=51 Participants 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 n=26 Participants 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 n=21 Participants 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 n=11 Participants 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)
Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Dressing From Baseline to Week 12 of the Double-blind Phase Week 4	-0.24 Points on a scale Standard Deviation 0.687	0.04 Points on a scale Standard Deviation 0.662	-0.33 Points on a scale Standard Deviation 0.483	0.00 Points on a scale Standard Deviation 0.000
Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Dressing From Baseline to Week 12 of the Double-blind Phase Week 6	-0.27 Points on a scale Standard Deviation 0.785	0.04 Points on a scale Standard Deviation 0.662	-0.24 Points on a scale Standard Deviation 0.436	-0.09 Points on a scale Standard Deviation 0.302
Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Dressing From Baseline to Week 12 of the Double-blind Phase Week 8	-0.21 Points on a scale Standard Deviation 0.713	0.08 Points on a scale Standard Deviation 0.717	-0.38 Points on a scale Standard Deviation 0.498	-0.09 Points on a scale Standard Deviation 0.302
Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Dressing From Baseline to Week 12 of the Double-blind Phase Week 12	-0.23 Points on a scale Standard Deviation 0.633	0.12 Points on a scale Standard Deviation 0.600	-0.24 Points on a scale Standard Deviation 0.436	0.00 Points on a scale Standard Deviation 0.000
Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Dressing From Baseline to Week 12 of the Double-blind Phase Week 1	-0.24 Points on a scale Standard Deviation 0.586	-0.04 Points on a scale Standard Deviation 0.344	-0.24 Points on a scale Standard Deviation 0.436	0.00 Points on a scale Standard Deviation 0.000

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 4, 6, 8, and 12

DAS score of Limb Posture was assessed using a 4-point scale (0=No functional disability to 3=Severe disability) at each time point in the double-blind phase.

Outcome measures

Outcome measures
Measure	High-Dose BTX n=51 Participants 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 n=26 Participants 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 n=21 Participants 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 n=11 Participants 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)
Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Limb Posture From Baseline to Week 12 of the Double-blind Phase Week 1	-0.43 Points on a scale Standard Deviation 0.539	-0.15 Points on a scale Standard Deviation 0.368	-0.33 Points on a scale Standard Deviation 0.483	-0.09 Points on a scale Standard Deviation 0.302
Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Limb Posture From Baseline to Week 12 of the Double-blind Phase Week 4	-0.62 Points on a scale Standard Deviation 0.602	-0.12 Points on a scale Standard Deviation 0.326	-0.48 Points on a scale Standard Deviation 0.602	-0.09 Points on a scale Standard Deviation 0.302
Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Limb Posture From Baseline to Week 12 of the Double-blind Phase Week 6	-0.69 Points on a scale Standard Deviation 0.683	-0.15 Points on a scale Standard Deviation 0.464	-0.67 Points on a scale Standard Deviation 0.796	-0.09 Points on a scale Standard Deviation 0.302
Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Limb Posture From Baseline to Week 12 of the Double-blind Phase Week 8	-0.67 Points on a scale Standard Deviation 0.694	-0.21 Points on a scale Standard Deviation 0.509	-0.52 Points on a scale Standard Deviation 0.680	0.00 Points on a scale Standard Deviation 0.447
Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Limb Posture From Baseline to Week 12 of the Double-blind Phase Week 12	-0.57 Points on a scale Standard Deviation 0.651	-0.16 Points on a scale Standard Deviation 0.473	-0.43 Points on a scale Standard Deviation 0.811	-0.09 Points on a scale Standard Deviation 0.539

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 4, 6, 8, and 12

The CGI score 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.

Outcome measures

Outcome measures
Measure	High-Dose BTX n=51 Participants 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 n=26 Participants 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 n=21 Participants 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 n=11 Participants 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)
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 Week 1	1.14 Points on a scale Standard Deviation 1.132	0.31 Points on a scale Standard Deviation 0.838	0.86 Points on a scale Standard Deviation 0.854	0.91 Points on a scale Standard Deviation 1.044
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 Week 4	1.80 Points on a scale Standard Deviation 1.456	0.50 Points on a scale Standard Deviation 1.175	1.10 Points on a scale Standard Deviation 1.044	0.45 Points on a scale Standard Deviation 0.820
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 Week 6	1.61 Points on a scale Standard Deviation 1.935	0.54 Points on a scale Standard Deviation 1.208	1.00 Points on a scale Standard Deviation 1.049	0.27 Points on a scale Standard Deviation 0.905
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 Week 8	1.33 Points on a scale Standard Deviation 1.950	0.42 Points on a scale Standard Deviation 1.139	0.86 Points on a scale Standard Deviation 1.108	0.27 Points on a scale Standard Deviation 0.905
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 Week 12	0.94 Points on a scale Standard Deviation 1.949	0.32 Points on a scale Standard Deviation 1.108	0.10 Points on a scale Standard Deviation 1.300	0.00 Points on a scale Standard Deviation 0.894

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 4, 6, 8, and 12

The CGI score 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.

Outcome measures

Outcome measures
Measure	High-Dose BTX n=51 Participants 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 n=26 Participants 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 n=21 Participants 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 n=11 Participants 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)
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 Week 1	1.14 Points on a scale Standard Deviation 1.296	0.73 Points on a scale Standard Deviation 1.343	1.29 Points on a scale Standard Deviation 1.231	0.36 Points on a scale Standard Deviation 1.120
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 Week 4	1.53 Points on a scale Standard Deviation 1.793	0.65 Points on a scale Standard Deviation 1.938	1.48 Points on a scale Standard Deviation 1.167	0.45 Points on a scale Standard Deviation 2.252
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 Week 6	1.78 Points on a scale Standard Deviation 1.918	0.73 Points on a scale Standard Deviation 1.614	1.24 Points on a scale Standard Deviation 1.411	0.55 Points on a scale Standard Deviation 2.382
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 Week 8	1.52 Points on a scale Standard Deviation 1.571	0.54 Points on a scale Standard Deviation 1.318	1.19 Points on a scale Standard Deviation 1.250	0.64 Points on a scale Standard Deviation 2.461
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 Week 12	1.32 Points on a scale Standard Deviation 1.733	0.92 Points on a scale Standard Deviation 1.956	0.90 Points on a scale Standard Deviation 1.136	0.18 Points on a scale Standard Deviation 2.442

SECONDARY outcome

Timeframe: Baseline; Weeks 1, 4, 6, 8, and 12

The CGI score 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.