A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GSK1358820 (Botulinum Toxin Type A) in Chinese Subjects With Post-stroke Upper Limb Spasticity

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT01153815

First received: June 17, 2010

Last updated: October 4, 2012

Last verified: May 2012

History of Changes

Results First Received: April 19, 2012

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
Condition:	Cerebrovascular Accident
Interventions:	Drug: GSK1358820(Botulinum toxin type A) Drug: placebo

Participant Flow

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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
Placebo	Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
BTX 200 U	Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).

Participant Flow: Overall Study

	Placebo	BTX 200 U
STARTED	83	87
COMPLETED	74	82
NOT COMPLETED	9	5
Adverse Event	3	1
Withdrawal by Subject	6	4

Baseline Characteristics

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Reporting Groups

	Description
Placebo	Matching placebo 4 milliliters (mL) was injected into the wrist and finger muscles. 0.8 mL was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
BTX 200 U	Botulinum Toxin Type A (BTX or GSK1358820) 200 Units (U) (4 mL) was injected into the wrist and finger muscles. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
Total	Total of all reporting groups

Baseline Measures

	Placebo	BTX 200 U	Total
Number of Participants [units: participants]	83	87	170
Age [units: Years] Mean ± Standard Deviation	56.3 ± 12.23	55.4 ± 10.69	55.8 ± 11.44
Gender [units: Participants]
Female	18	23	41
Male	65	64	129
Race/Ethnicity, Customized [units: Participants]
Chinese	83	87	170

Outcome Measures

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1. Primary:

Change From Baseline at Week 6 for Wrist Flexor Muscle Tone as Measured on the Modified Ashworth Scale (MAS) [ Time Frame: Baseline (Day 0) and Week 6 ]

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2. Secondary:

Area Under the Curve (AUC) for the Change From Baseline at Weeks 6 and 12 for MAS Wrist Score [ Time Frame: Baseline (Day 0), Week 6, and Week 12 ]

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3. Secondary:

Change From Baseline at Weeks 1, 4, 8, and 12 for Wrist Flexor Muscle Tone as Measured on the MAS [ Time Frame: Baseline (Day 0) and Weeks 1, 4, 8, and 12 ]

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4. Secondary:

Number of Participants Classified as Wrist Treatment Responders at All Post-injection Visits [ Time Frame: Weeks 1, 4, 6, 8, and 12 ]

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5. Secondary:

Change From Baseline at Weeks 1, 4, 6, 8, and 12 for Finger Flexor Muscle Tone as Measured on the MAS [ Time Frame: Baseline (Day 0) and Weeks 1, 4, 6, 8, and 12 ]

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6. Secondary:

Change From Baseline at Weeks 1, 4, 6, 8 and 12 for Thumb Flexor Muscle Tone as Measured on the MAS [ Time Frame: Baseline (Day 0) and Weeks 1, 4, 6, 8, and 12 ]

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7. Secondary:

Change From Baseline at Weeks 1, 4, 6, 8, and 12 for Principal Measure as Assessed on the Disability Assessment Scale (DAS) [ Time Frame: Baseline (Day 0) and Weeks 1, 4, 6, 8, and 12 ]

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8. Secondary:

Global Assessment Scale (GAS) Score as Evaluated by the Physician at the Indicated Time Points [ Time Frame: Weeks 1, 4, 6, 8, and 12 ]

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9. Secondary:

GAS Score as Evaluated by the Care Giver or the Participants at the Indicated Time Points [ Time Frame: Weeks 1, 4, 6, 8, and 12 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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
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Results Point of Contact:

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

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01153815 History of Changes
Other Study ID Numbers:	112958
Study First Received:	June 17, 2010
Results First Received:	April 19, 2012
Last Updated:	October 4, 2012
Health Authority:	China: Food and Drug Administration

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