Trial · NCT00460564
Study Of GSK1358820 In Patients With Post-Stroke Upper Limb Spasticity
NCT00460564, Phase 3, Completed, GlaxoSmithKline; results first posted 2010-02-10
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study Of GSK1358820 In Patients With Post-Stroke Upper Limb Spasticity. Trials, record NCT00460564. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00460564
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Of GSK1358820 In Patients With Post-Stroke Upper Limb Spasticity
- NCT number
- NCT00460564
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 109 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Post-Stroke Spasticity, Cerebrovascular Accident
- Interventions
- GSK1358820, Placebo
- First posted
- 2007-04-16
- Last updated
- 2017-05-30
- Results first posted
- 2010-02-10
- Limitations and caveats
The frequency threshold (5%) for reporting other adverse events is based on the result of the double-blind phase for the first four arms listed in the table and on the open-label phase for the last four arms listed in the table.
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under the Curve (AUC) for the Change From Baseline in Modified Ashworth Scale (MAS) Wrist Score to the End of the DB Phase (Week 12) in the High-dose Groups | 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. |
| Secondary | Area Under the Curve (AUC) for the Change From Baseline in Modified Ashworth Scale (MAS) Wrist Score to the End of the DB Phase (Week 12) in the Low-dose Groups | 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. |
| Secondary | Mean Change From Baseline in MAS Wrist Score From Baseline to Week 12 of the Double-blind Phase | 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. |
| Secondary | Mean Change From Baseline in MAS Finger Score From Baseline to Week 12 of the Double-blind Phase | 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. |
| Secondary | Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Principal Measure From Baseline to Week 12 of the Double-blind Phase | 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. |
| Secondary | Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Hygiene From Baseline to week12 of the Double-blind Phase | 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. |
| Secondary | Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Pain From Baseline to Week 12 of the Double-blind Phase | 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. |
| Secondary | Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Dressing From Baseline to Week 12 of the Double-blind Phase | 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. |
| Secondary | Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Limb Posture From Baseline to Week 12 of the Double-blind Phase | 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. |
| Secondary | Mean Change From Baseline in Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Investigator From Baseline to Week 12 of the Double-blind Phase | 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. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under the Curve (AUC) for the Change From Baseline in Modified Ashworth Scale (MAS) Wrist Score to the End of the DB Phase (Week 12) in the High-dose Groups | Baseline, Week 12 | 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 | Score*week | MEAN |
| SECONDARY | Area Under the Curve (AUC) for the Change From Baseline in Modified Ashworth Scale (MAS) Wrist Score to the End of the DB Phase (Week 12) in the Low-dose Groups | Baseline, Week 12 | 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 | Score*week | MEAN |
| SECONDARY | Mean Change From Baseline in MAS Wrist Score From Baseline to Week 12 of the Double-blind Phase | Baseline; Weeks 1, 4, 6, 8, and 12 | 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 | Points on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in MAS Finger Score From Baseline to Week 12 of the Double-blind Phase | Baseline; Weeks 1, 4, 6, 8, and 12 | 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 | Points on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Principal Measure From Baseline to Week 12 of the Double-blind Phase | Baseline; Weeks 1, 4, 6, 8, and 12 | 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 | Points on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Hygiene From Baseline to week12 of the Double-blind Phase | Baseline; Weeks 1, 4, 6, 8, and 12 | 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 | Points on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Pain From Baseline to Week 12 of the Double-blind Phase | Baseline; Weeks 1, 4, 6, 8, and 12 | 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 | Points on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Dressing From Baseline to Week 12 of the Double-blind Phase | Baseline; Weeks 1, 4, 6, 8, and 12 | 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 | Points on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Disability Assessment Scale (DAS) Score of Limb Posture From Baseline to Week 12 of the Double-blind Phase | Baseline; Weeks 1, 4, 6, 8, and 12 | 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 | Points on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Clinical Global Impression (CGI) Score of Functional Disability Assessed by the Investigator From Baseline to Week 12 of the Double-blind Phase | Baseline; Weeks 1, 4, 6, 8, and 12 | 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 | Points on a scale | MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group564
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | High-Dose BTX | -10.397 | Standard Deviation 8.9313 | Score*week | |
| 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 | High-Dose Placebo | -3.567 | Standard Deviation 4.7189 | Score*week | |
| 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 | Low-Dose BTX | -10.036 | Standard Deviation 7.7743 | Score*week | |
| 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 | Low-Dose Placebo | -6.227 | Standard Deviation 8.6584 | Score*week | |
| Mean Change From Baseline in MAS Wrist Score From Baseline to Week 12 of the Double-blind Phase | High-Dose BTX | Week 1 | -0.66 | Standard Deviation 0.745 | Points on a scale |
| Mean Change From Baseline in MAS Wrist Score From Baseline to Week 12 of the Double-blind Phase | High-Dose Placebo | Week 1 | -0.23 | Standard Deviation 0.430 | Points on a scale |
| Mean Change From Baseline in MAS Wrist Score From Baseline to Week 12 of the Double-blind Phase | Low-Dose BTX | Week 1 | -0.86 | Standard Deviation 0.777 | Points on a scale |
| Mean Change From Baseline in MAS Wrist Score From Baseline to Week 12 of the Double-blind Phase | Low-Dose Placebo | Week 1 | -0.50 | Standard Deviation 0.742 | Points on a scale |
| Mean Change From Baseline in MAS Wrist Score From Baseline to Week 12 of the Double-blind Phase | High-Dose BTX | Week 4 | -1.05 | Standard Deviation 0.912 | Points on a scale |
| Mean Change From Baseline in MAS Wrist Score From Baseline to Week 12 of the Double-blind Phase | High-Dose Placebo | Week 4 | -0.48 | Standard Deviation 0.671 | Points on a scale |
1 to 10 of 564Source ClinicalTrials.gov
See all 564 results by groupParticipant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Blind Phase (12 Weeks) | STARTED | High-Dose BTX | 51 | |
| Double-Blind Phase (12 Weeks) | STARTED | High-Dose Placebo | 26 | |
| Double-Blind Phase (12 Weeks) | STARTED | Low-Dose BTX | 21 | |
| Double-Blind Phase (12 Weeks) | STARTED | Low-Dose Placebo | 11 | |
| Double-Blind Phase (12 Weeks) | STARTED | DB High-Dose BTX + OL High-Dose BTX | 0 | |
| Double-Blind Phase (12 Weeks) | STARTED | DB High-Dose Placebo + OL High-Dose BTX | 0 | |
| Double-Blind Phase (12 Weeks) | STARTED | DB Low-Dose BTX + OL High-Dose BTX | 0 | |
| Double-Blind Phase (12 Weeks) | STARTED | DB Low-Dose Placebo + OL High-Dose BTX | 0 | |
| Double-Blind Phase (12 Weeks) | COMPLETED | High-Dose BTX | 47 | |
| Double-Blind Phase (12 Weeks) | COMPLETED | High-Dose Placebo | 25 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events616
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | High-Dose BTX | 7 | 51 | |
| other | Nasopharyngitis | Infections and infestations | High-Dose Placebo | 4 | 26 | |
| other | Nasopharyngitis | Infections and infestations | Low-Dose BTX | 3 | 21 | |
| other | Nasopharyngitis | Infections and infestations | Low-Dose Placebo | 1 | 11 | |
| other | Nasopharyngitis | Infections and infestations | DB High-Dose BTX + OL High-Dose BTX | 8 | 43 | |
| other | Nasopharyngitis | Infections and infestations | DB High-Dose Placebo + OL High-Dose BTX | 3 | 23 | |
| other | Nasopharyngitis | Infections and infestations | DB Low-Dose BTX + OL High-Dose BTX | 5 | 20 | |
| other | Nasopharyngitis | Infections and infestations | DB Low-Dose Placebo + OL High-Dose BTX | 5 | 11 | |
| other | Herpes zoster | Infections and infestations | High-Dose BTX | 1 | 51 | |
| other | Herpes zoster | Infections and infestations | High-Dose Placebo | 2 | 26 |
1 to 10 of 616Source ClinicalTrials.gov
See all 616 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | High-Dose BTX | ||
| Total, all-cause mortality | High-Dose Placebo | ||
| Total, all-cause mortality | Low-Dose BTX | ||
| Total, all-cause mortality | Low-Dose Placebo | ||
| Total, all-cause mortality | DB High-Dose BTX + OL High-Dose BTX | ||
| Total, all-cause mortality | DB High-Dose Placebo + OL High-Dose BTX | ||
| Total, all-cause mortality | DB Low-Dose BTX + OL High-Dose BTX | ||
| Total, all-cause mortality | DB Low-Dose Placebo + OL High-Dose BTX | ||
| Total, other adverse events | High-Dose BTX | 17 | 51 |
| Total, other adverse events | High-Dose Placebo | 12 | 26 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20569068 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00460564
GET https://conductscience.org/api/trials/v1/NCT00460564/registered?page=2