Post-Stroke SpasticityPhase 3NCT00460564
Study Of GSK1358820 In Patients With Post-Stroke Upper Limb Spasticity
A Phase 3 study testing GSK1358820 in people with Post-Stroke Spasticity and Cerebrovascular Accident, run by GlaxoSmithKline at 18 sites in Japan.
Trial summary
This is a study to confirm the superior efficacy of a single treatment of GSK1358820 over placebo in patients with post-stroke upper limb spasticity of both the wrist and finger flexors using the Modified Ashworth Scale (MAS) wrist score. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Post-Stroke Spasticity, Cerebrovascular Accident
- What is being tested?
- GSK1358820
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 18 sitesJapan
- Study dates
- May 2007to Dec 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects eligible for enrollment in the study must meet all of the following criteria:
- Patients with upper limb spasticity who are at least 6 months post stroke and present with spasticity of both the wrist and fingers at the start of double-blind phase (Visit 2).
- Wrist flexor muscle tone of ≥3 and finger flexor muscle tone of ≥2 on the MAS, and at least one functional disability item (i.e., hygiene, pain, dressing or limb posture) with a rating of ≥2 on the Disabilty Assessment Scale (DAS) at the start of double-blind phase (Visit 2).
- Male or female between 20 and 80 years of age at the time of informed consent. For males, only those who can practice contraception during the study period are eligible.
- ≥40kg in weight at the start of double-blind phase (Visit 2).
- Inpatient or outpatient; however, the hospitalization status must remain unchanged during the double-blind phase.
- Written informed consent from the subject him/herself. If the subject's signature is not legible, the attendance of a witness is required.
Who cannot join
- A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- Bilateral hemiplegia or quadriplegia.
- Presence of fixed contractures of the wrist and/or fingers (absence of range of motion).
- Profound atrophy of the muscles to be injected.
- Previous surgical intervention, phenol block, ethanol block, or muscle afferent block (MAB) for wrist and/or finger spasticity.
- Casting of the study upper limb within 3 months prior to the start of double-blind phase (Visit 2).
Show all 22Show fewer
- Current treatment with intrathecal baclofen.
- Use of peripheral muscle relaxants (dantrolene sodium, suxamethonium chloride, pancuronium bromide, vecuronium bromide, rocuronium bromide).
- Concurrent use of antibiotics that interfere with neuromuscular transmission, such as aminoglycoside antibiotics (e.g., streptomycin sulfate, kanamycin sulfate, gentamicin sulfate, neomycin sulphate, spectinomycin hydrochloride), polypeptide antibiotics (e.g., polymixin B sulfate), lincomycin antibiotics (e.g., lincomycin hydrochloride, clindamycin), and enviomycin sulfate.
- Previous botulinum toxin therapy.
- Diagnosis of systemic neuromuscular disorders (e.g., myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis).
- Females who are pregnant, nursing, may be pregnant, or planning a pregnancy during the study period.
- Known allergy or hypersensitivity to any ingredient of study medication (e.g., human serum albumin).
- Presence of psychiatric disorder or impairment of intellectual function that may interfere with the subject's ability to give informed consent or the conduct of the study.
- Bedridden patients.
- Presence of clinically unstable severe cardiovascular disease.
- Presence of clinically significant severe renal, hepatic or respiratory disease.
- Infection or dermatological condition at the proposed injection sites.
- Previous or planned participation in another clinical study (including the lower limb spasticity study of GSK1358820) within 6 months prior to the start of double-blind phase (Visit 2).
- Others whom the investigator or sub investigator considers not eligible for the study.
- Clinically significant severe reduction of muscle strength.
- Angle closure glaucoma or its preposition (narrow angle).
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Japan18 sites
GSK Investigational Site
Fukuoka, 811-0213
GSK Investigational Site
Hiroshima, 720-0825
GSK Investigational Site
Hiroshima, 728-0001
GSK Investigational Site
Hokkaido, 005-0802
GSK Investigational Site
Hokkaido, 006-0805
GSK Investigational Site
Hokkaido, 053-0803
GSK Investigational Site
Ibaraki, 302-0112
GSK Investigational Site
Kanagawa, 227-8518
GSK Investigational Site
Kanagawa, 247-8533
GSK Investigational Site
Kanagawa, 253-8558
GSK Investigational Site
Kanagawa, 257-0001
GSK Investigational Site
Kumamoto, 860-8518
GSK Investigational Site
Shizuoka, 410-1128
GSK Investigational Site
Shizuoka, 410-2507
GSK Investigational Site
Shizuoka, 410-3293
GSK Investigational Site
Tokyo, 105-8471
GSK Investigational Site
Tokyo, 142-8666
GSK Investigational Site
Yamaguchi, 740-0021
About this study
Official title: A Multicenter Study to Evaluate the Efficacy and Safety in Patients With Post-Stroke Upper Limb Spasticity Receiving a Double-Blind, Placebo-Controlled GSK1358820 Treatment Followed by an Open-Label GSK1358820 Treatment
This is a study to confirm the superior efficacy of a single treatment of GSK1358820 over placebo in patients with post-stroke upper limb spasticity of both the wrist and finger flexors using the Modified Ashworth Scale (MAS) wrist score.
Read the detailed description
This is a study to confirm the superior efficacy of a single treatment of GSK1358820 over placebo in patients with post-stroke upper limb spasticity of both the wrist and finger flexors using the Modified Ashworth Scale (MAS) wrist score.
- Conditions
- Post-Stroke Spasticity, Cerebrovascular Accident
- Being tested
- GSK1358820, Placebo
- Keywords
- Spasticity, Post-Stroke, botulinum toxin type A, Upper Limb
- Medical subject headings
- Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK1358820Drug
botulinum toxin type A
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| High-Dose BTX | Active comparator | Not described Receives: Drug: GSK1358820 |
| High-Dose Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Low-Dose BTX | Active comparator | Not described Receives: Drug: GSK1358820 |
| Low-Dose Placebo | Active comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: Baseline, Week 12
Secondary outcomes (21)
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
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.
Measured: Baseline, Week 12
Mean Change From Baseline in MAS Wrist Score From Baseline to Week 12 of the Double-blind Phase
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.
Measured: Baseline; Weeks 1, 4, 6, 8, and 12
Mean Change From Baseline in MAS Finger Score From Baseline to Week 12 of the Double-blind Phase
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.
Measured: Baseline; Weeks 1, 4, 6, 8, and 12
Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Principal Measure From Baseline to Week 12 of the Double-blind Phase
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.
Measured: Baseline; Weeks 1, 4, 6, 8, and 12
Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Hygiene From Baseline to week12 of the Double-blind Phase
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.
Measured: Baseline; Weeks 1, 4, 6, 8, and 12
Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Pain From Baseline to Week 12 of the Double-blind Phase
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.
Measured: Baseline; Weeks 1, 4, 6, 8, and 12
Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Dressing From Baseline to Week 12 of the Double-blind Phase
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.
Measured: Baseline; Weeks 1, 4, 6, 8, and 12
Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Limb Posture From Baseline to Week 12 of the Double-blind Phase
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.
Measured: Baseline; Weeks 1, 4, 6, 8, and 12
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
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.
Measured: Baseline; Weeks 1, 4, 6, 8, and 12
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
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.
Measured: Baseline; Weeks 1, 4, 6, 8, and 12
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
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.
Measured: Baseline; Weeks 1, 4, 6, 8, and 12
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
The investigator assessed the 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 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.
Measured: 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 MAS Finger Score From at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase
The investigator assessed the 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 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.
Measured: 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 Disability Assessment Scale (DAS) Score of Principal Measure at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase
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 from baseline (at the start of the double-blind phase) to Week 48.
Measured: 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 Disability Assessment Scale (DAS) Score of Hygiene at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase
The DAS score of Hygiene was assessed using a 4-point scale (0=No functional disability; 3=Severe disability) at each time point from baseline (at the start of the double-blind phase) to Week 48. BTX was injected in participants up to 3 times from Week 12 to Week 36 when participants met re-injection criteria. Measurements were taken at each point until Week 48 and summarized by the number of weeks after the re-injection in individuals (4, 8, and 12 weeks after each injection) in open-label phase; thus, measurements could have been taken up to Week 48 (12 weeks after the Week 36 injection).
Measured: 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 Disability Assessment Scale (DAS) Score of Pain at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase
The DAS score of Pain was assessed using a 4-point scale (0=No functional disability to 3=Severe disability) at each time point from baseline (at the start of the double-blind phase) to Week 48. BTX was injected in participants up to 3 times from Week 12 to Week 36 when participants met re-injection criteria. Measurements were taken at each point until Week 48 and summarized by the number of weeks after the re-injection in individuals (4, 8, and 12 weeks after each injection) in open-label phase; thus, measurements could have been taken up to Week 48 (12 weeks after the Week 36 injection).
Measured: 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 Disability Assessment Scale (DAS) Score of Dressing at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase
The DAS score of Dressing was assessed using a 4-point scale (0=No functional disability to 3=Severe disability) at each time point from baseline (at the start of the double-blind phase) to Week 48. BTX was injected in participants up to 3 times from Week 12 to Week 36 when participants met re-injection criteria. Measurements were taken at each point until Week 48 and summarized by the number of weeks after the re-injection in individuals (4, 8, and 12 weeks after each injection) in open-label phase; thus, measurements could have been taken up to Week 48 (12 weeks after the Week 36 injection).
Measured: 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 Disability Assessment Scale (DAS) Score of Limb Posture at 4, 8, and 12 Weeks After Each Injection in the Open-label Phase
The DAS score of Limb Posture was assessed using a 4-point scale (0=No functional disability to 3=Severe disability) at each time point from baseline (at the start of the double-blind phase) to Week 48. BTX was injected in participants up to 3 times from Weeks 12 to 36 when participants met re-injection criteria. Measurements were taken at each point until Week 48 and summarized by the number of weeks after the re-injection in individuals (4, 8, and 12 weeks after each injection) in open-label phase; thus, measurements could have been taken up to Week 48 (12 weeks after the Week 36 injection).
Measured: 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 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 from baseline (at the start of the double-blind phase) to Week 48.
Measured: 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 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 from baseline (at the start of the double-blind phase) to Week 48.
Measured: 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 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 from baseline (at the start of the double-blind phase) to Week 48.
Measured: Baseline; Weeks 4, 8, and 12 after each injection (up to Week 48; injections given from Week 12 to Week 36)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2007 (estimated)
- Study startMay 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-Stroke SpasticityStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00460564
- Sponsor's protocol ID
- BTX108509
- Status last verified
- May 2017
- First submitted
- 13 Apr 2007
- Last updated
- 30 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kaji R, Osako Y, Suyama K, Maeda T, Uechi Y, Iwasaki M; GSK1358820 Spasticity Study Group. Botulinum toxin type A in post-stroke upper limb spasticity. Curr Med Res Opin. 2010 Aug;26(8):1983-92. doi: 10.1185/03007995.2010.497103.
PubMed 20569068
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study to Evaluate the Efficacy and Safety in Patients With Post-Stroke Upper Limb Spasticity Receiving a Double-Blind, Placebo-Controlled GSK1358820 Treatment Followed by an Open-Label GSK1358820 Treatment
- ClinicalTrials.gov ID
- NCT00460564
- Acronym / sponsor ID
- BTX108509
- Conditions
- Post-Stroke Spasticity, Cerebrovascular Accident
- Keywords
- Spasticity, Post-Stroke, botulinum toxin type A, Upper Limb
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 16 Apr 2007 (estimated)
- Results
- Posted 10 Feb 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to confirm the superior efficacy of a single treatment of GSK1358820 over placebo in patients with post-stroke upper limb spasticity of both the wrist and finger flexors using the Modified Ashworth Scale (MAS) wrist score.
Detailed description
This is a study to confirm the superior efficacy of a single treatment of GSK1358820 over placebo in patients with post-stroke upper limb spasticity of both the wrist and finger flexors using the Modified Ashworth Scale (MAS) wrist score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High-Dose BTX | Active comparator | Drug: GSK1358820 |
| High-Dose Placebo | Placebo comparator | Drug: Placebo |
| Low-Dose BTX | Active comparator | Drug: GSK1358820 |
| Low-Dose Placebo | Active comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with upper limb spasticity who are at least 6 months post stroke and present with spasticity of both the wrist and fingers at the start of double-blind phase (Visit 2).
- Wrist flexor muscle tone of ≥3 and finger flexor muscle tone of ≥2 on the MAS, and at least one functional disability item (i.e., hygiene, pain, dressing or limb posture) with a rating of ≥2 on the Disabilty Assessment Scale (DAS) at the start of double-blind phase (Visit 2).
- Male or female between 20 and 80 years of age at the time of informed consent. For males, only those who can practice contraception during the study period are eligible.
- ≥40kg in weight at the start of double-blind phase (Visit 2).
- Inpatient or outpatient; however, the hospitalization status must remain unchanged during the double-blind phase.
Key exclusion criteria (22 listed)
- A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- Bilateral hemiplegia or quadriplegia.
- Presence of fixed contractures of the wrist and/or fingers (absence of range of motion).
- Profound atrophy of the muscles to be injected.
- Previous surgical intervention, phenol block, ethanol block, or muscle afferent block (MAB) for wrist and/or finger spasticity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK1358820botulinum toxin type A | Drug | High-Dose BTX, Low-Dose BTX |
| PlaceboPlacebo | Drug | High-Dose Placebo, Low-Dose Placebo |
Primary outcome
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
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.
21 secondary outcomes
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
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
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
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
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
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
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
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
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
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
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
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20569068Kaji R, Osako Y, Suyama K, Maeda T, Uechi Y, Iwasaki M; GSK1358820 Spasticity Study Group. Botulinum toxin type A in post-stroke upper limb spasticity. Curr Med Res Opin. 2010 Aug;26(8):1983-92. doi: 10.1185/03007995.2010.497103.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GSK1358820 in people with Post-Stroke Spasticity and Cerebrovascular Accident, run by GlaxoSmithKline at 18 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00460564, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.