Trial · NCT00564681
Study to Evaluate Safety, Efficacy of Botulinum Toxin Type A in Patients With Cervical Dystonia
NCT00564681, Phase 2, Completed, Allergan; results first posted 2012-12-11
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study to Evaluate Safety, Efficacy of Botulinum Toxin Type A in Patients With Cervical Dystonia. Trials, record NCT00564681. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00564681
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate Safety, Efficacy of Botulinum Toxin Type A in Patients With Cervical Dystonia
- NCT number
- NCT00564681
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 242 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Cervical Dystonia
- Interventions
- botulinum toxin type A, botulinum toxin type A Formulation 2, Normal Saline
- First posted
- 2007-11-28
- Last updated
- 2016-01-05
- Results first posted
- 2012-12-11
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 in Observed Total Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Score at Week 4 of Treatment Cycle 1 | Baseline, Week 4 | Change from baseline in observed TWSTRS score at Week 4 of Treatment Cycle 1. The TWSTRS is an assessment scale used to measure the impact of cervical dystonia on patients. The score is comprised of 3 subscales: Severity, Disability, and Pain, each of which is scored independently. The total of these 3 comprises the TWSTRS total score which is scored from 0 (least symptoms) to 85 (worst symptoms). Higher scores indicate a greater degree of symptom severity. A negative change from baseline represents improvement and a positive change from baseline indicates worsening. |
| Secondary | Physician's Global Assessment of Response to Treatment at Week 4 of Treatment Cycle 1 | Week 4 | Physician's global assessment of response to treatment at Week 4 of Treatment Cycle 1. Responses were measured on a 9-point scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (100% improvement)', 0 represented 'No change', and -4 represented 'Very marked worsening (about 100% worse or greater)'. |
| Secondary | Patient's Global Assessment of Response to Treatment at Week 4 of Treatment Cycle 1 | Week 4 | Patient's global assessment of response to treatment at Week 4 of Treatment Cycle 1. Responses were measured on a 9-point scale of +4 to -4, with higher scores denoting improvement in cervical dystonia: +4 was 'Complete abolishment of signs and symptoms (100% improvement)', 0 represented 'No change', and -4 represented 'Very marked worsening (about 100% worse or greater)'. |
| Secondary | Change From Baseline in Pain as Evaluated With the TWSTRS Pain Subscale at Week 4 of Treatment Cycle 1 | Baseline, Week 4 | Change from baseline in pain as evaluated with the TWSTRS pain subscale at Week 4 of Treatment Cycle 1. The TWSTRS pain subscale scores range from 0 to 20 (0=no pain and 20=worst pain), based on severity of neck pain (0=no pain and 10=worst pain), the duration of pain (0=none and 5=most), and the degree of disability (0=none and 5=most). A negative number change from Baseline represents a decrease in pain (improvement). |
| Secondary | Duration of Treatment Effect for Treatment Responders | Up to 6 Months | Duration of Treatment Effect for Treatment Responders is defined as the number of days from the date of first treatment to the first visit after Week 4 of Treatment Cycle 1, at which the Total TWSTRS score reaches at least 90% of the baseline score. A treatment responder is defined as a patient who has at least a 30% reduction in Total TWSTRS score at Week 4 after the first treatment. The TWSTRS score measures the impact of cervical dystonia on patients (0=least symptoms and 85= worst symptoms). |
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 in Observed Total Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Score at Week 4 of Treatment Cycle 1 | Baseline, Week 4 | Intent-To-Treat: All enrolled patients | Scores on a Scale | MEAN |
| SECONDARY | Physician's Global Assessment of Response to Treatment at Week 4 of Treatment Cycle 1 | Week 4 | Intent-to-Treat: All enrolled patients | Scores on a Scale | MEAN |
| SECONDARY | Patient's Global Assessment of Response to Treatment at Week 4 of Treatment Cycle 1 | Week 4 | Intent-to-Treat: All enrolled patients | Scores on a Scale | MEAN |
| SECONDARY | Change From Baseline in Pain as Evaluated With the TWSTRS Pain Subscale at Week 4 of Treatment Cycle 1 | Baseline, Week 4 | Intent-to-Treat: All enrolled patients | Scores on a Scale | MEAN |
| SECONDARY | Duration of Treatment Effect for Treatment Responders | Up to 6 Months | Intent-to-Treat: All enrolled patients | Days | MEDIAN |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Observed Total Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Score at Week 4 of Treatment Cycle 1 | Botulinum Toxin Type A | Baseline | 40.4 | Standard Deviation 9.14 | Scores on a Scale |
| Change From Baseline in Observed Total Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Score at Week 4 of Treatment Cycle 1 | Botulinum Toxin Type A Formulation 2 | Baseline | 41.5 | Standard Deviation 9.40 | Scores on a Scale |
| Change From Baseline in Observed Total Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Score at Week 4 of Treatment Cycle 1 | Placebo (Normal Saline) | Baseline | 39.6 | Standard Deviation 9.52 | Scores on a Scale |
| Change From Baseline in Observed Total Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Score at Week 4 of Treatment Cycle 1 | Botulinum Toxin Type A | Change from Baseline at Week 4 | -10.3 | Standard Deviation 9.77 | Scores on a Scale |
| Change From Baseline in Observed Total Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Score at Week 4 of Treatment Cycle 1 | Botulinum Toxin Type A Formulation 2 | Change from Baseline at Week 4 | -13.6 | Standard Deviation 10.20 | Scores on a Scale |
| Change From Baseline in Observed Total Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Score at Week 4 of Treatment Cycle 1 | Placebo (Normal Saline) | Change from Baseline at Week 4 | -5.6 | Standard Deviation 8.58 | Scores on a Scale |
| Physician's Global Assessment of Response to Treatment at Week 4 of Treatment Cycle 1 | Botulinum Toxin Type A | 1.3 | Standard Deviation 1.13 | Scores on a Scale | |
| Physician's Global Assessment of Response to Treatment at Week 4 of Treatment Cycle 1 | Botulinum Toxin Type A Formulation 2 | 1.6 | Standard Deviation 1.04 | Scores on a Scale | |
| Physician's Global Assessment of Response to Treatment at Week 4 of Treatment Cycle 1 | Placebo (Normal Saline) | 0.8 | Standard Deviation 1.00 | Scores on a Scale | |
| Patient's Global Assessment of Response to Treatment at Week 4 of Treatment Cycle 1 | Botulinum Toxin Type A | 1.3 | Standard Deviation 1.31 | Scores on a Scale |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Botulinum Toxin Type A | 117 | |
| Overall Study | STARTED | Botulinum Toxin Type A Formulation 2 | 61 | |
| Overall Study | STARTED | Placebo (Normal Saline) / Botulinum Toxin Type A | 43 | |
| Overall Study | STARTED | Placebo (Normal Saline) / Botulinum Toxin Type A Formulation 2 | 21 | |
| Overall Study | COMPLETED | Botulinum Toxin Type A | 106 | |
| Overall Study | COMPLETED | Botulinum Toxin Type A Formulation 2 | 58 | |
| Overall Study | COMPLETED | Placebo (Normal Saline) / Botulinum Toxin Type A | 40 | |
| Overall Study | COMPLETED | Placebo (Normal Saline) / Botulinum Toxin Type A Formulation 2 | 19 | |
| Overall Study | NOT COMPLETED | Botulinum Toxin Type A | 11 | |
| Overall Study | NOT COMPLETED | Botulinum Toxin Type A Formulation 2 | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events156
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 | Neck Pain | Musculoskeletal and connective tissue disorders | Botulinum Toxin Type A | 20 | 117 | |
| other | Neck Pain | Musculoskeletal and connective tissue disorders | Botulinum Toxin Type A Formulation 2 | 10 | 61 | |
| other | Neck Pain | Musculoskeletal and connective tissue disorders | Placebo (Normal Saline) / Botulinum Toxin Type A | 5 | 42 | |
| other | Neck Pain | Musculoskeletal and connective tissue disorders | Placebo (Normal Saline) / Botulinum Toxin Type A Formulation 2 | 1 | 21 | |
| other | Muscular weakness | Musculoskeletal and connective tissue disorders | Botulinum Toxin Type A | 19 | 117 | |
| other | Muscular weakness | Musculoskeletal and connective tissue disorders | Botulinum Toxin Type A Formulation 2 | 2 | 61 | |
| other | Muscular weakness | Musculoskeletal and connective tissue disorders | Placebo (Normal Saline) / Botulinum Toxin Type A | 4 | 42 | |
| other | Muscular weakness | Musculoskeletal and connective tissue disorders | Placebo (Normal Saline) / Botulinum Toxin Type A Formulation 2 | 5 | 21 | |
| other | Dysphagia | Gastrointestinal disorders | Botulinum Toxin Type A | 10 | 117 | |
| other | Dysphagia | Gastrointestinal disorders | Botulinum Toxin Type A Formulation 2 | 7 | 61 |
1 to 10 of 156Source ClinicalTrials.gov
See all 156 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Botulinum Toxin Type A | ||
| Total, all-cause mortality | Botulinum Toxin Type A Formulation 2 | ||
| Total, all-cause mortality | Placebo (Normal Saline) / Botulinum Toxin Type A | ||
| Total, all-cause mortality | Placebo (Normal Saline) / Botulinum Toxin Type A Formulation 2 | ||
| Total, other adverse events | Botulinum Toxin Type A | 83 | 117 |
| Total, other adverse events | Botulinum Toxin Type A Formulation 2 | 41 | 61 |
| Total, other adverse events | Placebo (Normal Saline) / Botulinum Toxin Type A | 31 | 42 |
| Total, other adverse events | Placebo (Normal Saline) / Botulinum Toxin Type A Formulation 2 | 16 | 21 |
| Total, serious adverse events | Botulinum Toxin Type A | 9 | 117 |
| Total, serious adverse events | Botulinum Toxin Type A Formulation 2 | 1 | 61 |
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/NCT00564681
GET https://conductscience.org/api/trials/v1/NCT00564681/results?page=2