Study of GSK1358820 In Patients With Post-Stroke Lower Limb Spasticity

This study has been completed.

Sponsor:

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00460655

First received: April 13, 2007

Last updated: August 30, 2010

Last verified: August 2010

History of Changes

Results First Received: September 2, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Post-Stroke Spasticity Cerebrovascular Accident
Interventions:	Drug: GSK1358820 Drug: Placebo

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
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)
Placebo	Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
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])
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])

Participant Flow for 2 periods

Period 1: Double-Blind Phase (12 Weeks)

	BTX 300U	Placebo
STARTED	58	62
COMPLETED	52	61
NOT COMPLETED	6	1
Adverse Event	3	0
Withdrawal by Subject	3	0
Protocol Violation	0	1

Period 2: Open-Label Phase (36 Weeks)

	DB BTX + OL BTX	DB Placebo + OL BTX
STARTED	52	61
COMPLETED	45	52
NOT COMPLETED	7	9
Adverse Event	1	6
Withdrawal by Subject	6	2
Meeting the Exclusion Criteria	0	1

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
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)
Placebo	Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
Total	Total of all reporting groups

Baseline Measures

	BTX 300U	Placebo	Total
Number of Participants [units: participants]	58	62	120
Age [units: years] Mean ± Standard Deviation	62.4 ± 8.66	62.5 ± 9.32	62.5 ± 8.97
Gender [units: participants]
Female	8	16	24
Male	50	46	96
Race/Ethnicity, Customized [units: participants]
Asian-Japanese	58	62	120

Outcome Measures

Show All Outcome Measures

1. 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) [ Time Frame: Baseline, Week 12 ]

Show Outcome Measure 1

2. Secondary:

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

Show Outcome Measure 2

3. Secondary:

Mean Change From Baseline in the Physician's Rating Score (PRS) From Baseline to Week 12 of the Double-blind Phase [ Time Frame: Baseline; Weeks 1, 4, 6, 8, and 12 ]

Show Outcome Measure 3

4. Secondary:

Mean Change From Baseline in the Time (Seconds) to Walk 10 Meters From Baseline to Week 12 of the Double-blind Phase [ Time Frame: Baseline; Weeks 1, 4, 6, 8, and 12 ]

Show Outcome Measure 4

5. 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 [ Time Frame: Baseline; Weeks 1, 4, 6, 8, and 12 ]

Show Outcome Measure 5

6. 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 [ Time Frame: Baseline; Weeks 1, 4, 6, 8, and 12 ]

Show Outcome Measure 6

7. 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 [ Time Frame: Baseline; Weeks 1, 4, 6, 8, and 12 ]

Show Outcome Measure 7

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

Show Outcome Measure 8

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

Show Outcome Measure 9

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

Show Outcome Measure 10

11. 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) ]

Hide Outcome Measure 11

Measure Type	Secondary
Measure Title	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
Measure Description	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.
Time Frame	Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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

Reporting Groups

	Description
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])
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])

Measured Values

	DB BTX + OL BTX	DB Placebo + OL BTX
Number of Participants Analyzed [units: participants]	50	57
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 [units: Points on a scale] Mean ± Standard Deviation
Week 4 after first injection in OL	1.43 ± 1.443	1.43 ± 1.463
Week 8 after first injection in OL	1.40 ± 1.393	1.54 ± 1.513
Week 12 after first injection in OL	1.11 ± 1.387	1.21 ± 1.589
Week 4 after second injection in OL	1.93 ± 1.639	2.02 ± 1.550
Week 8 after second injection in OL	1.70 ± 1.670	1.89 ± 1.676
Week 12 after second injection in OL	1.55 ± 1.611	1.52 ± 1.683
Week 4 after third injection in OL	2.07 ± 1.387	1.59 ± 1.476
Week 8 after third injection in OL	2.04 ± 1.224	1.82 ± 1.389
Week 12 after third injection in OL	2.00 ± 1.177	1.68 ± 1.416

No statistical analysis provided for 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

12. 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) ]

Show Outcome Measure 12

13. 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) ]

Show Outcome Measure 13

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:

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. Epub 2010 Apr 1.

ClinicalTrials.gov Identifier:	NCT00460655 History of Changes
Other Study ID Numbers:	BTX108512
Study First Received:	April 13, 2007
Results First Received:	September 2, 2009
Last Updated:	August 30, 2010
Health Authority:	Japan: Ministry of Health, Labor and Welfare

To Top