Cervical DystoniaPhase 4NCT00702754
Open Label Safety/Immunogenicity Study of MYOBLOC (Neurobloc; Botulinum Toxin Type B) in Patients With Cervical Dystonia
A Phase 4 study testing Botulinum Toxin Type B in people with Cervical Dystonia, run by Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC.
Trial summary
Open label study to evaluate the safety and immunogenicity of MYOBLOC (Botulinum Toxin Type B) in adult patients with a clinical diagnosis of Cervical Dystonia (CD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Dystonia
- What is being tested?
- Botulinum Toxin Type B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 502 participants
- Where
- No sites listed yet
- Study dates
- Jun 2001to Sep 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- body weight of at least 46 kilograms
- History of Cervical Dystonia of at least one year's duration who in the opinion of the Investigator requires treatment
Who cannot join
- Inability to give informed consent
- Patient who has been previously treated with botulinum Toxin Type B
- Patient who has received a Botulinum toxin Type A injection in the last 12 weeks.
- History of phenol injections involving the neck or shoulder region in the last 12 months.
- Patients with neck contractures or cervical spine disease
About this study
Official title: An Open Label Safety and Immunogenicity Study of MYOBLOC (Neurobloc; Botulinum Toxin Type B) Injectable Solution in Patients With Cervical Dystonia
Open label study to evaluate the safety and immunogenicity of MYOBLOC (Botulinum Toxin Type B) in adult patients with a clinical diagnosis of Cervical Dystonia (CD).
Read the detailed description
This is an open-label study aimed to assess long-term safety and immunogenicity of MYOBLOC (Botulinum Toxin Type B) in adult patients with a clinical diagnosis of Cervical Dystonia (CD). Up to 500 adult patients with a confirmed clinical diagnosis of CD are planned for enrollment into this open label study. These patients will be Type B toxin naive patients with CD. During this study, patients will receive repeat injections of MYOBLOC every 12 weeks when deemed appropriate by the Investigator. Injections should not occur more frequently than every 12 weeks. Total duration of exposure to MYOBLOC will be targeted for at least two years, with potential exposure for up to 7 years in patients with earliest enrollment.
- Conditions
- Cervical Dystonia
- Being tested
- Botulinum Toxin Type B
- Medical subject headings
- Torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin Type BBiological
Also called MYOBLOC
Eligible patients could receive injections of MYOBLOC once every 12 weeks. Total Dose could range from 5,000 Units up to 25,000 Units.
| Study group | Role | What they receive |
|---|---|---|
| Open-Label Treatment | Experimental | 5,000 units up to 25,000 units of MYOBLOC (Botulinum Toxin Type B) injections every 12 weeks Receives: Biological: Botulinum Toxin Type B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Assessment Scale (TAS), 4 Wks Post-injection Compared to Baseline (Time 0), Rating of Cervical Dystonia Symptoms
7 point rating scale (-3 = significantly worse, 0 = no change, +3 = significantly better. Comparison at Wk 4 to baseline. Rating of Cervical Dystonia Symptoms
Measured: Session 1 - Time 0, 4 weeks post-injection compared to baseline
Secondary outcomes (7)
Treatment Assessment Scale (TAS), Approx Wk 12 + 4 Wks Post-Injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
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
Measured: Session 2 (12 wks) - 4 weeks post-injection compared to baseline
Treatment Assessment Scale (TAS), Approx Wk 24 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
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
Measured: Session 3 (24 Wks) - 4 weeks post-injection compared to baseline
Treatment Assessment Scale (TAS), Approx Wk 36 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
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
Measured: Session 4 (36 Wks) - 4 weeks post-injection compared to baseline
Treatment Assessment Scale (TAS), Approx Wk 48 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
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
Measured: Session 5 (48 Wks) - 4 weeks post-injection compared to baseline
Treatment Assessment Scale (TAS), Approx Wk 60 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
7 point scale (-3=significantly worse, 0=no change, +3=significantly better). comparison Wk 60 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms
Measured: Session 6 (60 Wks) - 4 weeks post-injection compared to baseline
Treatment Assessment Scale (TAS), Approx Wk 72 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison Wk 72 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms
Measured: Session 7 (72 Wks) - 4 weeks post-injection compared to baseline
Treatment Assessment Scale (TAS), Approx Wk 84 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison Wk 84 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms
Measured: Session 8 (84 Wks) - 4 weeks post-injection compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2008 (estimated)
- Study startJun 2001
- Primary completionMay 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical DystoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 502 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan T Rubin, MD, Study director, Supernus Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00702754
- Sponsor's protocol ID
- AN072-401CD/NA
- Status last verified
- Apr 2026
- First submitted
- 12 Jun 2008
- Last updated
- 11 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Safety and Immunogenicity Study of MYOBLOC (Neurobloc; Botulinum Toxin Type B) Injectable Solution in Patients With Cervical Dystonia
- ClinicalTrials.gov ID
- NCT00702754
- Acronym / sponsor ID
- AN072-401CD/NA
- Conditions
- Cervical Dystonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 502 participants (actual)
- Lead sponsor
- Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2001
- Primary completion
- May 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 20 Jun 2008 (estimated)
- Results
- Posted 23 Sep 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open label study to evaluate the safety and immunogenicity of MYOBLOC (Botulinum Toxin Type B) in adult patients with a clinical diagnosis of Cervical Dystonia (CD).
Detailed description
This is an open-label study aimed to assess long-term safety and immunogenicity of MYOBLOC (Botulinum Toxin Type B) in adult patients with a clinical diagnosis of Cervical Dystonia (CD). Up to 500 adult patients with a confirmed clinical diagnosis of CD are planned for enrollment into this open label study. These patients will be Type B toxin naive patients with CD. During this study, patients will receive repeat injections of MYOBLOC every 12 weeks when deemed appropriate by the Investigator. Injections should not occur more frequently than every 12 weeks. Total duration of exposure to MYOBLOC will be targeted for at least two years, with potential exposure for up to 7 years in patients with earliest enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-Label Treatment | Experimental | Biological: Botulinum Toxin Type B5,000 units up to 25,000 units of MYOBLOC (Botulinum Toxin Type B) injections every 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- body weight of at least 46 kilograms
- History of Cervical Dystonia of at least one year's duration who in the opinion of the Investigator requires treatment
Key exclusion criteria (5 listed)
- Inability to give informed consent
- Patient who has been previously treated with botulinum Toxin Type B
- Patient who has received a Botulinum toxin Type A injection in the last 12 weeks.
- History of phenol injections involving the neck or shoulder region in the last 12 months.
- Patients with neck contractures or cervical spine disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Toxin Type BAlso: MYOBLOCEligible patients could receive injections of MYOBLOC once every 12 weeks. Total Dose could range from 5,000 Units up to 25,000 Units. | Biological | Open-Label Treatment |
Primary outcome
Treatment Assessment Scale (TAS), 4 Wks Post-injection Compared to Baseline (Time 0), Rating of Cervical Dystonia Symptoms
Time frame: 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
7 secondary outcomes
Treatment Assessment Scale (TAS), Approx Wk 12 + 4 Wks Post-Injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
Time frame: Session 2 (12 wks) - 4 weeks post-injection compared to baseline
Treatment Assessment Scale (TAS), Approx Wk 24 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
Time frame: Session 3 (24 Wks) - 4 weeks post-injection compared to baseline
Treatment Assessment Scale (TAS), Approx Wk 36 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
Time frame: Session 4 (36 Wks) - 4 weeks post-injection compared to baseline
Treatment Assessment Scale (TAS), Approx Wk 48 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
Time frame: Session 5 (48 Wks) - 4 weeks post-injection compared to baseline
Treatment Assessment Scale (TAS), Approx Wk 60 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
Time frame: Session 6 (60 Wks) - 4 weeks post-injection compared to baseline
Treatment Assessment Scale (TAS), Approx Wk 72 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
Time frame: Session 7 (72 Wks) - 4 weeks post-injection compared to baseline
Treatment Assessment Scale (TAS), Approx Wk 84 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
Time frame: Session 8 (84 Wks) - 4 weeks post-injection compared to baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Cervical Dystonia
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Dystonia
Not yet recruitingObservational study
Assessment of Cervical Range of Motion Restrictions in Infants With Arthrogenic Torticollis - A Feasibility Study
Torticollis (Arthrogenic)
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Effect of Vibro-tactile Stimulation Intensity on Head Posture in Cervical Dystonia
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An Observational Study of Individuals With Isolated Dystonia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan T Rubin, MD study director
Supernus Pharmaceuticals, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Botulinum Toxin Type B in people with Cervical Dystonia, run by Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Sep 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Assessment Scale (TAS), 4 Wks Post-injection Compared to Baseline (Time 0), Rating of Cervical Dystonia Symptoms (time frame: Session 1 - Time 0, 4 weeks post-injection compared to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.