Trial · NCT00761592
Comparison of Two Botulinum Type A Products in the Treatment of Blepharospasm
NCT00761592, Phase 4, Completed, Allergan; results first posted 2009-07-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparison of Two Botulinum Type A Products in the Treatment of Blepharospasm. Trials, record NCT00761592. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00761592
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Two Botulinum Type A Products in the Treatment of Blepharospasm
- NCT number
- NCT00761592
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 65 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Blepharospasm
- Interventions
- Botulinum Toxin Type A 900kDa, Botulinum Toxin Type A 150kDa
- First posted
- 2008-09-29
- Last updated
- 2013-11-19
- Results first posted
- 2009-07-09
- Limitations and caveats
- This was a pilot study.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Week 4 in Blepharospasm Disability Index | Baseline to Week 4 | Blepharospasm Disability Index is a validated 5-point scale (0-4) with six items (e.g., reading, driving a vehicle). 0 - no impairment, 1 - mild impairment, 2 - moderate impairment, 3 - severe impairment, 4 - not possible due to disease, N/A - Not applicable. The total score ranged from 0 (no impairment) to 24 (not possible due to disease). A negative change from baseline indicated improvement. |
| Secondary | Change From Baseline to Week 8 in Blepharospasm Disability Index | Baseline to Week 8 | Blepharospasm Disability Index is a validated 5-point (0-4) scale with six items (e.g., reading, driving a vehicle). 0 - no impairment, 1 - mild impairment, 2 - moderate impairment, 3 - severe impairment, 4 - not possible due to disease, N/A - Not applicable. The total score ranged from 0 (no impairment) to 24 (not possible due to disease). A negative change from baseline indicated improvement. |
| Secondary | Change From Baseline to Week 4 and Week 8 in Total Jankovic Rating Scale (JRS) (Severity and Frequency Measured on a Scale of 0-4) | Baseline to Week 4 and Week 8 | Jankovic Rating Scale Severity: 0 - None; 1 - Minimal; 2 - Mild; 3 - Moderate; 4 - Severe. Frequency: 0 - None; 1 - Slight increase; 2 - Fluttering duration less than 1 second; 3 - Spasm greater than 1 second and eyes open \> 50% of waking time; 4 - Functionally blind. The range of the total score was from 0 (None) to 8 (Severe and Functionally Blind). A negative change from baseline indicated improvement. |
| Secondary | Changes From Baseline to Week 4 and Week 8 in Patient Global Assessment (PGA) Score | Baseline to Week 4 and 8 | Subjective satisfaction rating: -4: marked worsening, -3: moderate worsening, -2: marked worsening in symptoms, -1: mild worsening in symptoms, 0: no effect +1: mild improvement in symptoms, +2: moderate improvement in symptoms, +3: mild improvement, +4: marked improvement. A positive change from baseline indicated improvement. |
| Secondary | Duration of Action | Interval between initial injection (Week 0) and final visit (Week 11 through Week 14) | Median Duration for decision to reinject |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Week 4 in Blepharospasm Disability Index | Baseline to Week 4 | Intention to Treat | Points on Scale | MEAN |
| SECONDARY | Change From Baseline to Week 8 in Blepharospasm Disability Index | Baseline to Week 8 | Intention to Treat | Points on Scale | MEAN |
| SECONDARY | Change From Baseline to Week 4 and Week 8 in Total Jankovic Rating Scale (JRS) (Severity and Frequency Measured on a Scale of 0-4) | Baseline to Week 4 and Week 8 | Intention to Treat | Points on Scale | MEAN |
| SECONDARY | Changes From Baseline to Week 4 and Week 8 in Patient Global Assessment (PGA) Score | Baseline to Week 4 and 8 | Intention to Treat | Points on Scale | MEAN |
| SECONDARY | Duration of Action | Interval between initial injection (Week 0) and final visit (Week 11 through Week 14) | Intention to Treat | Weeks | MEDIAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Week 4 in Blepharospasm Disability Index | Botulinum Toxin Type A 900kDa | -2.8 | Standard Deviation 5.3 | Points on Scale | |
| Change From Baseline to Week 4 in Blepharospasm Disability Index | Botulinum Toxin Type A 150kDa | -1.3 | Standard Deviation 3.7 | Points on Scale | |
| Change From Baseline to Week 8 in Blepharospasm Disability Index | Botulinum Toxin Type A 900kDa | -1.3 | Standard Deviation 3.9 | Points on Scale | |
| Change From Baseline to Week 8 in Blepharospasm Disability Index | Botulinum Toxin Type A 150kDa | -0.8 | Standard Deviation 3.2 | Points on Scale | |
| Change From Baseline to Week 4 and Week 8 in Total Jankovic Rating Scale (JRS) (Severity and Frequency Measured on a Scale of 0-4) | Botulinum Toxin Type A 900kDa | Change in JRS in Left Eye at Week 4 | -2.3 | Standard Deviation 1.5 | Points on Scale |
| Change From Baseline to Week 4 and Week 8 in Total Jankovic Rating Scale (JRS) (Severity and Frequency Measured on a Scale of 0-4) | Botulinum Toxin Type A 150kDa | Change in JRS in Left Eye at Week 4 | -1.5 | Standard Deviation 1.5 | Points on Scale |
| Change From Baseline to Week 4 and Week 8 in Total Jankovic Rating Scale (JRS) (Severity and Frequency Measured on a Scale of 0-4) | Botulinum Toxin Type A 900kDa | Change in JRS in Right Eye at Week 4 | -2.2 | Standard Deviation 1.5 | Points on Scale |
| Change From Baseline to Week 4 and Week 8 in Total Jankovic Rating Scale (JRS) (Severity and Frequency Measured on a Scale of 0-4) | Botulinum Toxin Type A 150kDa | Change in JRS in Right Eye at Week 4 | -1.5 | Standard Deviation 1.5 | Points on Scale |
| Change From Baseline to Week 4 and Week 8 in Total Jankovic Rating Scale (JRS) (Severity and Frequency Measured on a Scale of 0-4) | Botulinum Toxin Type A 900kDa | Change in JRS in Left Eye at Week 8 | -1.9 | Standard Deviation 1.7 | Points on Scale |
| Change From Baseline to Week 4 and Week 8 in Total Jankovic Rating Scale (JRS) (Severity and Frequency Measured on a Scale of 0-4) | Botulinum Toxin Type A 150kDa | Change in JRS in Left Eye at Week 8 | -1.3 | Standard Deviation 1.3 | Points on Scale |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Botulinum Toxin Type A 900kDa | 32 | |
| Overall Study | STARTED | Botulinum Toxin Type A 150kDa | 33 | |
| Overall Study | COMPLETED | Botulinum Toxin Type A 900kDa | 31 | |
| Overall Study | COMPLETED | Botulinum Toxin Type A 150kDa | 32 | |
| Overall Study | NOT COMPLETED | Botulinum Toxin Type A 900kDa | 1 | |
| Overall Study | NOT COMPLETED | Botulinum Toxin Type A 150kDa | 1 |
Source ClinicalTrials.gov
Adverse events44
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 | Diplopia | Eye disorders | Botulinum Toxin Type A 900kDa | 1 | 31 | |
| other | Diplopia | Eye disorders | Botulinum Toxin Type A 150kDa | 0 | 33 | |
| other | Dry Eye | Eye disorders | Botulinum Toxin Type A 900kDa | 0 | 31 | |
| other | Dry Eye | Eye disorders | Botulinum Toxin Type A 150kDa | 1 | 33 | |
| other | Eye Swelling | Eye disorders | Botulinum Toxin Type A 900kDa | 0 | 31 | |
| other | Eye Swelling | Eye disorders | Botulinum Toxin Type A 150kDa | 1 | 33 | |
| other | Eyelid oedema | Eye disorders | Botulinum Toxin Type A 900kDa | 0 | 31 | |
| other | Eyelid oedema | Eye disorders | Botulinum Toxin Type A 150kDa | 1 | 33 | |
| other | Lacrimation increased | Eye disorders | Botulinum Toxin Type A 900kDa | 1 | 31 | |
| other | Lacrimation increased | Eye disorders | Botulinum Toxin Type A 150kDa | 0 | 33 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Botulinum Toxin Type A 900kDa | ||
| Total, all-cause mortality | Botulinum Toxin Type A 150kDa | ||
| Total, other adverse events | Botulinum Toxin Type A 900kDa | 21 | |
| Total, other adverse events | Botulinum Toxin Type A 150kDa | 24 | |
| Total, serious adverse events | Botulinum Toxin Type A 900kDa | 1 | |
| Total, serious adverse events | Botulinum Toxin Type A 150kDa | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT00761592
GET https://conductscience.org/api/trials/v1/NCT00761592/events?page=2