Trial · NCT01896895
Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Abnormal Contraction or Twitch of the Eyelid
NCT01896895, Phase 3, Completed, Merz Pharmaceuticals GmbH; results first posted 2018-03-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Abnormal Contraction or Twitch of the Eyelid. Trials, record NCT01896895. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01896895
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Abnormal Contraction or Twitch of the Eyelid
- NCT number
- NCT01896895
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 61 participants, actual
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Conditions
- Bilateral Blepharospasm (BEB)
- Interventions
- IncobulinumtoxinA (Xeomin), 25 Units, IncobotulinumtoxinA (Xeomin), 12.5 Units, Placebo, IncobotulinumtoxinA (Xeomin), 35 Units
- First posted
- 2013-07-11
- Last updated
- 2018-03-01
- Other registries' IDs
- eudract:2012-004821-26
- Results first posted
- 2018-03-01
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Double-blind MP: Change From Baseline in JRS Severity Subscore at Day 43 (Visit 4) | Baseline, Day 43 (Visit 4) | JRS severity subscore was used to classify individual symptoms of blepharospasm and to determine therapeutic efficacy. JRS severity subscore ranges from 0 to 4, where 0: None; 1: increased blinking present with external stimuli; 2: Mild but spontaneous eyelid fluttering, definitely noticeable, possibly embarrassing, but not functionally disabling, 3: Moderate, very noticeable spasm of eyelids only, mildly incapacitating, 4: Severe, incapacitating spasm of eyelids and possibly other facial muscles. Values represent least square (LS) mean differences between baseline and visit 4 resulting from analysis of covariance (ANCOVA) with treatment group, pooled site, and gender as fixed factors and baseline JRS severity subscore and age as covariates and missings replaced using the last observation carried forward (LOCF) method. Negative values denote improvement, while positive values denote deterioration vs. baseline. |
| Secondary | Double-blind MP: Change From Baseline in Blepharospasm Disability Index (BSDI) at Day 43 (Visit 4) | Baseline, Day 43 (Visit 4) | BSDI is a scale for assessment of impairment of specific activities of daily living caused by blepharospasm. BSDI consists of six items (driving a vehicle; reading; watching TV; shopping; getting about on foot (walking); doing everyday activities), each ranging from 0 (=no impairment) to 4 (=no longer possible due to illness). The BSDI total score is a mean score for non-missing items ranging from 0 to 4. It is calculated by adding scores of all applicable and answered items, and dividing the resulting sum by the number of items answered. Outcome values represent LS mean differences between baseline and visit 4 (visit 4 value minus baseline value) resulting from ANCOVA with treatment group, pooled site, gender as fixed factors and baseline BSDI total score, age as covariates. Missings were replaced by the LOCF method. Negative values denote an improvement, while positive values denote deterioration vs. baseline. |
| Secondary | Double-blind MP: Patient Evaluation of Global Response (PEGR) at Final Visit (Day 43-Day 141) | Baseline, Final Visit (Day 43-Day 141) | PEGR scale is a descriptive subjective 9-point response self-rating scale ranging from "complete abolishment of signs and symptoms" (value=+4) down to "very marked worsening" (value=-4). Outcome values represent least square means at visit 4 resulting from an ANCOVA with treatment group, pooled site, gender as fixed factors and age as covariates. Missing were set to a zero effect (value=0). Positive values denote an improvement, while negative values denote deterioration. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Double-blind MP: Change From Baseline in JRS Severity Subscore at Day 43 (Visit 4) | Baseline, Day 43 (Visit 4) | FAS was subset of participants in the SES of the double-blind MP for whom at least a baseline value of the JRS severity subscore was available. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Double-blind MP: Change From Baseline in Blepharospasm Disability Index (BSDI) at Day 43 (Visit 4) | Baseline, Day 43 (Visit 4) | FAS was subset of participants in the SES of the double-blind MP for whom at least a baseline value of the JRS severity subscore was available. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Double-blind MP: Patient Evaluation of Global Response (PEGR) at Final Visit (Day 43-Day 141) | Baseline, Final Visit (Day 43-Day 141) | FAS was subset of participants in the SES of the double-blind MP for whom at least a baseline value of the JRS severity subscore was available. | score on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Double-blind MP: Change From Baseline in JRS Severity Subscore at Day 43 (Visit 4) | Double-blind MP: Placebo | -0.6 | 95% Confidence Interval -1.0 to -0.1 | score on a scale | |
| Double-blind MP: Change From Baseline in JRS Severity Subscore at Day 43 (Visit 4) | Double-blind MP: IncobotulinumtoxinA 25 Units | -1.0 | 95% Confidence Interval -1.5 to -0.6 | score on a scale | |
| Double-blind MP: Change From Baseline in JRS Severity Subscore at Day 43 (Visit 4) | Double-blind MP: IncobotulinumtoxinA 50 Units | -1.8 | 95% Confidence Interval -2.3 to -1.3 | score on a scale | |
| Double-blind MP: Change From Baseline in Blepharospasm Disability Index (BSDI) at Day 43 (Visit 4) | Double-blind MP: Placebo | -0.4 | 95% Confidence Interval -0.8 to 0.0 | score on a scale | |
| Double-blind MP: Change From Baseline in Blepharospasm Disability Index (BSDI) at Day 43 (Visit 4) | Double-blind MP: IncobotulinumtoxinA 25 Units | -0.5 | 95% Confidence Interval -0.9 to -0.2 | score on a scale | |
| Double-blind MP: Change From Baseline in Blepharospasm Disability Index (BSDI) at Day 43 (Visit 4) | Double-blind MP: IncobotulinumtoxinA 50 Units | -0.7 | 95% Confidence Interval -1.1 to -0.3 | score on a scale | |
| Double-blind MP: Patient Evaluation of Global Response (PEGR) at Final Visit (Day 43-Day 141) | Double-blind MP: Placebo | 1.3 | 95% Confidence Interval 0.7 to 1.9 | score on a scale | |
| Double-blind MP: Patient Evaluation of Global Response (PEGR) at Final Visit (Day 43-Day 141) | Double-blind MP: IncobotulinumtoxinA 25 Units | 1.8 | 95% Confidence Interval 1.2 to 2.4 | score on a scale | |
| Double-blind MP: Patient Evaluation of Global Response (PEGR) at Final Visit (Day 43-Day 141) | Double-blind MP: IncobotulinumtoxinA 50 Units | 2.2 | 95% Confidence Interval 1.5 to 2.8 | score on a scale |
Source ClinicalTrials.gov
Participant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind MP | STARTED | Double-blind MP: Placebo | 20 | |
| Double-blind MP | STARTED | Double-blind MP: IncobotulinumtoxinA 25 Units | 22 | |
| Double-blind MP | STARTED | Double-blind MP: IncobotulinumtoxinA 50 Units | 19 | |
| Double-blind MP | STARTED | OLEX: IncobotulinumtoxinA 70 Units | 0 | |
| Double-blind MP | COMPLETED | Double-blind MP: Placebo | 19 | |
| Double-blind MP | COMPLETED | Double-blind MP: IncobotulinumtoxinA 25 Units | 20 | |
| Double-blind MP | COMPLETED | Double-blind MP: IncobotulinumtoxinA 50 Units | 16 | |
| Double-blind MP | COMPLETED | OLEX: IncobotulinumtoxinA 70 Units | 0 | |
| Double-blind MP | NOT COMPLETED | Double-blind MP: Placebo | 1 | |
| Double-blind MP | NOT COMPLETED | Double-blind MP: IncobotulinumtoxinA 25 Units | 2 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events144
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 | Blood creatine increased | Investigations | Double-blind MP: Placebo | 0 | 20 | 0 |
| other | Blood creatine increased | Investigations | Double-blind MP: IncobotulinumtoxinA 25 Units | 1 | 22 | 1 |
| other | Blood creatine increased | Investigations | Double-blind MP: IncobotulinumtoxinA 50 Units | 0 | 19 | 0 |
| other | Blood creatine increased | Investigations | OLEX: IncobotulinumtoxinA 70 Units | 0 | 39 | 0 |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Double-blind MP: Placebo | 0 | 20 | 0 |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Double-blind MP: IncobotulinumtoxinA 25 Units | 0 | 22 | 0 |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Double-blind MP: IncobotulinumtoxinA 50 Units | 1 | 19 | 1 |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | OLEX: IncobotulinumtoxinA 70 Units | 0 | 39 | 0 |
| other | Hypoaesthesia | Nervous system disorders | Double-blind MP: Placebo | 0 | 20 | 0 |
| other | Hypoaesthesia | Nervous system disorders | Double-blind MP: IncobotulinumtoxinA 25 Units | 0 | 22 | 0 |
1 to 10 of 144Source ClinicalTrials.gov
See all 144 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Double-blind MP: Placebo | 0 | 20 |
| Total, all-cause mortality | Double-blind MP: IncobotulinumtoxinA 25 Units | 0 | 22 |
| Total, all-cause mortality | Double-blind MP: IncobotulinumtoxinA 50 Units | 0 | 19 |
| Total, all-cause mortality | OLEX: IncobotulinumtoxinA 70 Units | 0 | 39 |
| Total, other adverse events | Double-blind MP: Placebo | 6 | 20 |
| Total, other adverse events | Double-blind MP: IncobotulinumtoxinA 25 Units | 7 | 22 |
| Total, other adverse events | Double-blind MP: IncobotulinumtoxinA 50 Units | 7 | 19 |
| Total, other adverse events | OLEX: IncobotulinumtoxinA 70 Units | 4 | 39 |
| Total, serious adverse events | Double-blind MP: Placebo | 0 | 20 |
| Total, serious adverse events | Double-blind MP: IncobotulinumtoxinA 25 Units | 2 | 22 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers3
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 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/NCT01896895
GET https://conductscience.org/api/trials/v1/NCT01896895/flow?page=2