Trial · NCT00406367
IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Blepharospasm
NCT00406367, Phase 3, Completed, Merz Pharmaceuticals GmbH; results first posted 2010-11-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Blepharospasm. Trials, record NCT00406367. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00406367
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Blepharospasm
- NCT number
- NCT00406367
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 109 participants, actual
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Conditions
- Blepharospasm
- Interventions
- incobotulinumtoxinA (Xeomin), Placebo
- First posted
- 2006-12-04
- Last updated
- 2013-03-15
- Results first posted
- 2010-11-16
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Jankovic Rating Scale (JRS) Change From Baseline in the JRS Severity Subscore at Week 6 After Injection (Assessed by a Blinded Independent Rater) | Baseline, week 6 | The Jankovic Rating Scale (JRS) is used for classification of the patient's individual symptoms of blepharospasm and for determination of the therapeutic efficacy of study medication. The JRS sumscore is the sum of the two components of the scale: * JRS-Severity score which ranges from 0 (=absence of severity) to 4 (=maximum severity) * JRS-Frequency score which ranges from 0 (=no frequency) to 4 (=maximum frequency) The change from baseline was calculated as the score at the corresponding visit minus the baseline score. |
| Secondary | Jankovic Rating Scale (JRS) Change From Baseline in the JRS Severity Subscore at Week 6 After Injection (Assessed by Subject Diary) | Baseline, week 6 | The Jankovic Rating Scale (JRS) is used for classification of the patient's individual symptoms of blepharospasm and for determination of the therapeutic efficacy of study medication. The JRS sumscore is the sum of the two components of the scale: * JRS-Severity score which ranges from 0 (=absence of severity) to 4 (=maximum severity) * JRS-Frequency score which ranges from 0 (=no frequency) to 4 (=maximum frequency) The change from baseline was calculated as the score at the corresponding visit minus the baseline score. |
| Secondary | Blepharospasm Disability Index (BSDI) Change From Baseline in the BSDI at Week 6 After Injection | Baseline, week 6 | The Blepharospasm Disability Index is a scale for the assessment of impairment of specific activities of daily living caused by blepharospasm. The BSDI consists of six items (driving a vehicle; reading; watching TV; shopping; getting about on foot (walking); doing everyday activities), each ranges from 0 (=no impairment) to 4 (=no longer possible due to illness). The change from baseline was calculated as the score at the corresponding visit minus the baseline score. |
| Secondary | Patient Evaluation of Global Response (PEGR) at Final Visit | Final visit (up to week 20 after injection of the Main Period) | The PEGR is a descriptive subjective 9-point response scale ranging from "complete abolishment of signs and symptoms" (value=+4) down to "very marked worsening" (value=-4). |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Jankovic Rating Scale (JRS) Change From Baseline in the JRS Severity Subscore at Week 6 After Injection (Assessed by a Blinded Independent Rater) | Baseline, week 6 | Intention to treat population: all participants randomized were included in the primary efficacy analysis; Last Observation Carried Forward (LOCF) imputation technique used for missing values | Points on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Jankovic Rating Scale (JRS) Change From Baseline in the JRS Severity Subscore at Week 6 After Injection (Assessed by Subject Diary) | Baseline, week 6 | Intention to treat population by using the Last Observation Carried Forward (LOCF) imputation technique for missing values | Points on a scale | MEAN |
| SECONDARY | Blepharospasm Disability Index (BSDI) Change From Baseline in the BSDI at Week 6 After Injection | Baseline, week 6 | Intention to treat population by using the Last Observation Carried Forward (LOCF) imputation technique for missing values | Points on a scale | MEAN |
| SECONDARY | Patient Evaluation of Global Response (PEGR) at Final Visit | Final visit (up to week 20 after injection of the Main Period) | Intention to treat population with missing values imputed by no effect. | Points on a scale | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Jankovic Rating Scale (JRS) Change From Baseline in the JRS Severity Subscore at Week 6 After Injection (Assessed by a Blinded Independent Rater) | incobotulinumtoxinA (Xeomin) | -0.8 | Standard Error 0.13 | Points on a scale | |
| Jankovic Rating Scale (JRS) Change From Baseline in the JRS Severity Subscore at Week 6 After Injection (Assessed by a Blinded Independent Rater) | Placebo | 0.2 | Standard Error 0.18 | Points on a scale | |
| Jankovic Rating Scale (JRS) Change From Baseline in the JRS Severity Subscore at Week 6 After Injection (Assessed by Subject Diary) | incobotulinumtoxinA (Xeomin) | -0.75 | Standard Deviation 1.24 | Points on a scale | |
| Jankovic Rating Scale (JRS) Change From Baseline in the JRS Severity Subscore at Week 6 After Injection (Assessed by Subject Diary) | Placebo | 0.16 | Standard Deviation 1.07 | Points on a scale | |
| Blepharospasm Disability Index (BSDI) Change From Baseline in the BSDI at Week 6 After Injection | incobotulinumtoxinA (Xeomin) | -0.4 | Standard Deviation 0.69 | Points on a scale | |
| Blepharospasm Disability Index (BSDI) Change From Baseline in the BSDI at Week 6 After Injection | Placebo | 0.11 | Standard Deviation 0.67 | Points on a scale | |
| Patient Evaluation of Global Response (PEGR) at Final Visit | incobotulinumtoxinA (Xeomin) | 1.3 | Standard Deviation 2.09 | Points on a scale | |
| Patient Evaluation of Global Response (PEGR) at Final Visit | Placebo | -0.6 | Standard Deviation 2.16 | Points on a scale |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Main Period - 6 to 20 Weeks | STARTED | incobotulinumtoxinA (Xeomin) | 75 | |
| Main Period - 6 to 20 Weeks | STARTED | Placebo | 34 | |
| Main Period - 6 to 20 Weeks | COMPLETED | incobotulinumtoxinA (Xeomin) | 70 | |
| Main Period - 6 to 20 Weeks | COMPLETED | Placebo | 32 | |
| Main Period - 6 to 20 Weeks | NOT COMPLETED | incobotulinumtoxinA (Xeomin) | 5 | |
| Main Period - 6 to 20 Weeks | NOT COMPLETED | Placebo | 2 | |
| Open-Label Ext. Period - up to 68 Weeks | STARTED | incobotulinumtoxinA (Xeomin) | 102 | |
| Open-Label Ext. Period - up to 68 Weeks | STARTED | Placebo | 0 | |
| Open-Label Ext. Period - up to 68 Weeks | COMPLETED | incobotulinumtoxinA (Xeomin) | 82 | |
| Open-Label Ext. Period - up to 68 Weeks | COMPLETED | Placebo | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events26
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 | Diarrhoea | Gastrointestinal disorders | incobotulinumtoxinA (Xeomin) | 6 | 74 | 6 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 0 | 34 | 0 |
| other | Dry eye | Eye disorders | incobotulinumtoxinA (Xeomin) | 14 | 74 | 16 |
| other | Dry eye | Eye disorders | Placebo | 4 | 34 | 4 |
| other | Dry mouth | Gastrointestinal disorders | incobotulinumtoxinA (Xeomin) | 11 | 74 | 11 |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 1 | 34 | 1 |
| other | Dysphagia | Gastrointestinal disorders | incobotulinumtoxinA (Xeomin) | 3 | 74 | 3 |
| other | Dysphagia | Gastrointestinal disorders | Placebo | 2 | 34 | 2 |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | incobotulinumtoxinA (Xeomin) | 4 | 74 | 4 |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Placebo | 0 | 34 | 0 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | incobotulinumtoxinA (Xeomin) | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | incobotulinumtoxinA (Xeomin) | 45 | 74 |
| Total, other adverse events | Placebo | 13 | 34 |
| Total, serious adverse events | incobotulinumtoxinA (Xeomin) | 0 | 74 |
| Total, serious adverse events | Placebo | 1 | 34 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| incobotulinumtoxinA (Xeomin) vs Placebo: serious adverse events |
Source Trial comparisons
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/NCT00406367
GET https://conductscience.org/api/trials/v1/NCT00406367/events?page=2