Trial · NCT00702754
Open Label Safety/Immunogenicity Study of MYOBLOC (Neurobloc; Botulinum Toxin Type B) in Patients With Cervical Dystonia
NCT00702754, Phase 4, Completed, Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC; results first posted 2009-09-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Open Label Safety/Immunogenicity Study of MYOBLOC (Neurobloc; Botulinum Toxin Type B) in Patients With Cervical Dystonia. Trials, record NCT00702754. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00702754
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open Label Safety/Immunogenicity Study of MYOBLOC (Neurobloc; Botulinum Toxin Type B) in Patients With Cervical Dystonia
- NCT number
- NCT00702754
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 502 participants, actual
- Lead sponsor
- Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC
- Conditions
- Cervical Dystonia
- Interventions
- Botulinum Toxin Type B
- First posted
- 2008-06-20
- Last updated
- 2026-05-11
- Results first posted
- 2009-09-23
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment Assessment Scale (TAS), 4 Wks Post-injection Compared to Baseline (Time 0), Rating of Cervical Dystonia Symptoms | Session 1 - Time 0, 4 weeks post-injection compared to baseline | 7 point rating scale (-3 = significantly worse, 0 = no change, +3 = significantly better. Comparison at Wk 4 to baseline. Rating of Cervical Dystonia Symptoms |
| Secondary | Treatment Assessment Scale (TAS), Approx Wk 12 + 4 Wks Post-Injection Compared to Baseline. Rating of Cervical Dystonia Symptoms | Session 2 (12 wks) - 4 weeks post-injection compared to baseline | 7 point rating scale (-3=significantly worse, 0=no change, +3=significantly better), comparison of Wk 12 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms |
| Secondary | Treatment Assessment Scale (TAS), Approx Wk 24 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms | Session 3 (24 Wks) - 4 weeks post-injection compared to baseline | 7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison of Wk 24 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms |
| Secondary | Treatment Assessment Scale (TAS), Approx Wk 36 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms | Session 4 (36 Wks) - 4 weeks post-injection compared to baseline | 7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison of Wk 36 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms |
| Secondary | Treatment Assessment Scale (TAS), Approx Wk 48 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms | Session 5 (48 Wks) - 4 weeks post-injection compared to baseline | 7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison of Wk 48 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms |
| Secondary | Treatment Assessment Scale (TAS), Approx Wk 60 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms | Session 6 (60 Wks) - 4 weeks post-injection compared to baseline | 7 point scale (-3=significantly worse, 0=no change, +3=significantly better). comparison Wk 60 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms |
| Secondary | Treatment Assessment Scale (TAS), Approx Wk 72 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms | Session 7 (72 Wks) - 4 weeks post-injection compared to baseline | 7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison Wk 72 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms |
| Secondary | Treatment Assessment Scale (TAS), Approx Wk 84 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms | Session 8 (84 Wks) - 4 weeks post-injection compared to baseline | 7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison Wk 84 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Treatment Assessment Scale (TAS), 4 Wks Post-injection Compared to Baseline (Time 0), Rating of Cervical Dystonia Symptoms | Session 1 - Time 0, 4 weeks post-injection compared to baseline | Safety Population/Intent to Treat | points on a scale | MEAN |
| SECONDARY | Treatment Assessment Scale (TAS), Approx Wk 12 + 4 Wks Post-Injection Compared to Baseline. Rating of Cervical Dystonia Symptoms | Session 2 (12 wks) - 4 weeks post-injection compared to baseline | safety population/Intent to Treat | points on a scale | MEAN |
| SECONDARY | Treatment Assessment Scale (TAS), Approx Wk 24 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms | Session 3 (24 Wks) - 4 weeks post-injection compared to baseline | safety population/Intent to Treat | points on a scale | MEAN |
| SECONDARY | Treatment Assessment Scale (TAS), Approx Wk 36 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms | Session 4 (36 Wks) - 4 weeks post-injection compared to baseline | safety population/Intent to Treat | points on a scale | MEAN |
| SECONDARY | Treatment Assessment Scale (TAS), Approx Wk 48 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms | Session 5 (48 Wks) - 4 weeks post-injection compared to baseline | Safety Population/Intent to Treat | points on a scale | MEAN |
| SECONDARY | Treatment Assessment Scale (TAS), Approx Wk 60 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms | Session 6 (60 Wks) - 4 weeks post-injection compared to baseline | Safety Population/Intent to Treat | points on a scale | MEAN |
| SECONDARY | Treatment Assessment Scale (TAS), Approx Wk 72 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms | Session 7 (72 Wks) - 4 weeks post-injection compared to baseline | Safety Population/Intent to Treat | points on a scale | MEAN |
| SECONDARY | Treatment Assessment Scale (TAS), Approx Wk 84 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms | Session 8 (84 Wks) - 4 weeks post-injection compared to baseline | Safety Population/Intent to Treat | 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 |
|---|---|---|---|---|---|
| Treatment Assessment Scale (TAS), 4 Wks Post-injection Compared to Baseline (Time 0), Rating of Cervical Dystonia Symptoms | MYOBLOC Open Label Treatment | 0.9 | Standard Error 0.1 | points on a scale | |
| Treatment Assessment Scale (TAS), Approx Wk 12 + 4 Wks Post-Injection Compared to Baseline. Rating of Cervical Dystonia Symptoms | MYOBLOC Open Label Treatment | 1.3 | Standard Deviation 0.1 | points on a scale | |
| Treatment Assessment Scale (TAS), Approx Wk 24 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms | MYOBLOC Open Label Treatment | 1.5 | Standard Deviation 0.1 | points on a scale | |
| Treatment Assessment Scale (TAS), Approx Wk 36 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms | MYOBLOC Open Label Treatment | 1.4 | Standard Deviation 0.1 | points on a scale | |
| Treatment Assessment Scale (TAS), Approx Wk 48 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms | MYOBLOC Open Label Treatment | 1.5 | Standard Deviation 0.1 | points on a scale | |
| Treatment Assessment Scale (TAS), Approx Wk 60 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms | MYOBLOC Open Label Treatment | 1.4 | Standard Deviation 0.1 | points on a scale | |
| Treatment Assessment Scale (TAS), Approx Wk 72 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms | MYOBLOC Open Label Treatment | 1.5 | Standard Deviation 0.1 | points on a scale | |
| Treatment Assessment Scale (TAS), Approx Wk 84 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms | MYOBLOC Open Label Treatment | 1.4 | Standard Deviation 0.1 | points 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 |
|---|---|---|---|---|
| MYOBLOC Treatment Session 1 (Time 0) | STARTED | MYOBLOC Open Label Treatment | 502 | |
| MYOBLOC Treatment Session 1 (Time 0) | COMPLETED | MYOBLOC Open Label Treatment | 495 | |
| MYOBLOC Treatment Session 1 (Time 0) | NOT COMPLETED | MYOBLOC Open Label Treatment | 7 | |
| MYOBLOC Treatment Session 2 (App 12 Wks) | STARTED | MYOBLOC Open Label Treatment | 495 | |
| MYOBLOC Treatment Session 2 (App 12 Wks) | COMPLETED | MYOBLOC Open Label Treatment | 475 | |
| MYOBLOC Treatment Session 2 (App 12 Wks) | NOT COMPLETED | MYOBLOC Open Label Treatment | 20 | |
| MYOBLOC Treatment Session 3 (App 24 Wks) | STARTED | MYOBLOC Open Label Treatment | 475 | |
| MYOBLOC Treatment Session 3 (App 24 Wks) | COMPLETED | MYOBLOC Open Label Treatment | 450 | |
| MYOBLOC Treatment Session 3 (App 24 Wks) | NOT COMPLETED | MYOBLOC Open Label Treatment | 25 | |
| MYOBLOC Treatment Session 4 (App 36 Wks) | STARTED | MYOBLOC Open Label Treatment | 450 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events232
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 | Palpitations | Cardiac disorders | MYOBLOC Open Label Treatment | 11 | 502 | 11 |
| other | vertigo | Ear and labyrinth disorders | MYOBLOC Open Label Treatment | 18 | 502 | 18 |
| other | hypothyroidism | Endocrine disorders | MYOBLOC Open Label Treatment | 10 | 502 | 10 |
| other | cataract | Eye disorders | MYOBLOC Open Label Treatment | 10 | 502 | 10 |
| other | conjunctivitis | Eye disorders | MYOBLOC Open Label Treatment | 11 | 502 | 11 |
| other | dry eye | Eye disorders | MYOBLOC Open Label Treatment | 10 | 502 | 10 |
| other | vision blurred | Eye disorders | MYOBLOC Open Label Treatment | 12 | 502 | 12 |
| other | abdominal pain | Gastrointestinal disorders | MYOBLOC Open Label Treatment | 29 | 502 | 29 |
| other | abdominal pain upper | Gastrointestinal disorders | MYOBLOC Open Label Treatment | 15 | 502 | 15 |
| other | constipation | Gastrointestinal disorders | MYOBLOC Open Label Treatment | 43 | 502 | 43 |
1 to 10 of 232Source ClinicalTrials.gov
See all 232 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MYOBLOC Open Label Treatment | ||
| Total, other adverse events | MYOBLOC Open Label Treatment | 494 | |
| Total, serious adverse events | MYOBLOC Open Label Treatment | 133 |
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
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The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00702754
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