Trial · NCT00165776
Randomized, Double-Blind, Placebo-Controlled, Parallel, Group Dose-Response, Study of E2014 in Patients WIth Spasmodic Torticollis
NCT00165776, Phase 2, Completed, Eisai Co., Ltd.; results first posted 2014-01-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Randomized, Double-Blind, Placebo-Controlled, Parallel, Group Dose-Response, Study of E2014 in Patients WIth Spasmodic Torticollis. Trials, record NCT00165776. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00165776
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized, Double-Blind, Placebo-Controlled, Parallel, Group Dose-Response, Study of E2014 in Patients WIth Spasmodic Torticollis
- NCT number
- NCT00165776
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 133 participants, actual
- Lead sponsor
- Eisai Co., Ltd.
- Conditions
- Cervical Dystonia, Spasmodic Torticollis
- Interventions
- BOTULINUM TOXIN TYPE B
- First posted
- 2005-09-14
- Last updated
- 2014-03-10
- Results first posted
- 2014-01-08
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Treatment | Baseline, Week 4 | The TWSTRS-Total score is the sum of scores of the three components of the scale: * TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity) * TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain) * TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability). The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score. |
| Secondary | Mean Change From Baseline in Patient Global Assessment - Visual Analog Scale (PtGA-VAS) at Week 4 After Treatment | Baseline, Week 4 | Change from Baseline in PtGA-VAS is computed as Week 4 value minus baseline value. A negative value in change from baseline indicates an improvement. Participants answered: "Considering all the ways your cervical dystonia affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly. |
| Secondary | Mean Change From Baseline in Physician Global Assessment Disease Assessment - Visual Analog Scale (PGA-VAS) at Week 4 After Treatment | Baseline, Week 4 | Change from Baseline in PGA-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as Week 4 value minus baseline value. A negative value in change from baseline indicates an improvement. |
| Secondary | Mean Change From Baseline in the TWSTRS - Functional Disability Score at Week 4 After Treatment | Baseline, Week 4 | TWSTRS-Disability score which ranges from 0 (=no disability)to 30 (=maximum disability). The change from baseline was calculated as the score at the corresponding visit minus the baseline score. |
| Secondary | Mean Change From Baseline in the TWSTRS - Pain Score at Week 4 After Treatment | Baseline, Week 4 | TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain). The change from baseline was calculated as the score at the corresponding visit minus the baseline score. |
| Secondary | Mean Change From Baseline in the TWSTRS - Severity Score at Week 4 After Treatment | Baseline, Week 4 | TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity). The change from baseline was calculated as the score at the corresponding visit minus the baseline score. |
| Secondary | Mean Change From Baseline in Patient Pain Assessment (VAS) at Week 4 After Treatment | Baseline, Week 4 | Change from Baseline in Patient's Pain Assessment-VAS is computed as Week 4 value minus baseline value. A negative value in change from baseline indicates an improvement. The patient's assessment of pain was performed using a 100 mm VAS)ranging from no pain (0) to unbearable pain (100). The distance in mm from the left edge of the scale was measured. A negative change from Baseline score indicates improvement in pain intensity. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Mean Change From Baseline in Patient Global Assessment - Visual Analog Scale (PtGA-VAS) at Week 4 After Treatment | Baseline, Week 4 | FAS | Millimeters | MEAN |
| SECONDARY | Mean Change From Baseline in Physician Global Assessment Disease Assessment - Visual Analog Scale (PGA-VAS) at Week 4 After Treatment | Baseline, Week 4 | FAS | Millimeters | MEAN |
| PRIMARY | Mean Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Treatment | Baseline, Week 4 | Full Analysis Set (FAS) population: All subjects who received study treatment | Points on a Scale | MEAN |
| SECONDARY | Mean Change From Baseline in the TWSTRS - Functional Disability Score at Week 4 After Treatment | Baseline, Week 4 | FAS | Points on a Scale | MEAN |
| SECONDARY | Mean Change From Baseline in the TWSTRS - Pain Score at Week 4 After Treatment | Baseline, Week 4 | FAS | Points on a Scale | MEAN |
| SECONDARY | Mean Change From Baseline in the TWSTRS - Severity Score at Week 4 After Treatment | Baseline, Week 4 | FAS | Points on a Scale | MEAN |
| SECONDARY | Mean Change From Baseline in Patient Pain Assessment (VAS) at Week 4 After Treatment | Baseline, Week 4 | FAS | Millimeters | MEAN |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline in Patient Global Assessment - Visual Analog Scale (PtGA-VAS) at Week 4 After Treatment | Placebo | -0.4 | Standard Error 3.2 | Millimeters | |
| Mean Change From Baseline in Patient Global Assessment - Visual Analog Scale (PtGA-VAS) at Week 4 After Treatment | E2014 2,500 U | 11.9 | Standard Error 2.6 | Millimeters | |
| Mean Change From Baseline in Patient Global Assessment - Visual Analog Scale (PtGA-VAS) at Week 4 After Treatment | E2014 5,000 U | 9.9 | Standard Error 3 | Millimeters | |
| Mean Change From Baseline in Patient Global Assessment - Visual Analog Scale (PtGA-VAS) at Week 4 After Treatment | E2014 10,000 U | 13.3 | Standard Error 3 | Millimeters | |
| Mean Change From Baseline in Physician Global Assessment Disease Assessment - Visual Analog Scale (PGA-VAS) at Week 4 After Treatment | Placebo | 2 | Standard Error 2.2 | Millimeters | |
| Mean Change From Baseline in Physician Global Assessment Disease Assessment - Visual Analog Scale (PGA-VAS) at Week 4 After Treatment | E2014 2,500 U | 10.6 | Standard Error 2.9 | Millimeters | |
| Mean Change From Baseline in Physician Global Assessment Disease Assessment - Visual Analog Scale (PGA-VAS) at Week 4 After Treatment | E2014 5,000 U | 11.2 | Standard Error 2.6 | Millimeters | |
| Mean Change From Baseline in Physician Global Assessment Disease Assessment - Visual Analog Scale (PGA-VAS) at Week 4 After Treatment | E2014 10,000 U | 16.9 | Standard Error 2.8 | Millimeters | |
| Mean Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Treatment | Placebo | 3 | Standard Error 1.3 | Points on a Scale | |
| Mean Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Treatment | E2014 2,500 U | 8.9 | Standard Error 1.8 | Points on a Scale |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 35 | |
| Overall Study | STARTED | E2014 2,500 U | 34 | |
| Overall Study | STARTED | E2014 5,000 U | 33 | |
| Overall Study | STARTED | E2014 10,000 U | 31 | |
| Overall Study | COMPLETED | Placebo | 31 | |
| Overall Study | COMPLETED | E2014 2,500 U | 33 | |
| Overall Study | COMPLETED | E2014 5,000 U | 31 | |
| Overall Study | COMPLETED | E2014 10,000 U | 29 | |
| Overall Study | NOT COMPLETED | Placebo | 4 | |
| Overall Study | NOT COMPLETED | E2014 2,500 U | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events40
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 | Placebo | 9 | 33 | |
| other | Nasopharyngitis | Infections and infestations | E2014 2,500 U | 2 | 34 | |
| other | Nasopharyngitis | Infections and infestations | E2014 5,000 U | 4 | 32 | |
| other | Nasopharyngitis | Infections and infestations | E2014 10,000 U | 6 | 31 | |
| other | Dysphagia | Gastrointestinal disorders | Placebo | 0 | 33 | |
| other | Dysphagia | Gastrointestinal disorders | E2014 2,500 U | 1 | 34 | |
| other | Dysphagia | Gastrointestinal disorders | E2014 5,000 U | 3 | 32 | |
| other | Dysphagia | Gastrointestinal disorders | E2014 10,000 U | 7 | 31 | |
| other | Thirst | General disorders | Placebo | 1 | 33 | |
| other | Thirst | General disorders | E2014 2,500 U | 1 | 34 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | E2014 2,500 U | ||
| Total, all-cause mortality | E2014 5,000 U | ||
| Total, all-cause mortality | E2014 10,000 U | ||
| Total, other adverse events | Placebo | 9 | 33 |
| Total, other adverse events | E2014 2,500 U | 3 | 34 |
| Total, other adverse events | E2014 5,000 U | 4 | 32 |
| Total, other adverse events | E2014 10,000 U | 7 | 31 |
| Total, serious adverse events | Placebo | 0 | 33 |
| Total, serious adverse events | E2014 2,500 U | 0 | 34 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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/NCT00165776
GET https://conductscience.org/api/trials/v1/NCT00165776/results?page=2