An Open Label Safety and Immunogenicity Study of MYOBLOC (Neurobloc; Botulinum Toxin Type B) Injectable Solution in Patients With Cervical Dystonia

Study Overview
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Brief Summary
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Five hundred patients with a confirmed clinical diagnosis of Cervical Dystonia (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 when deemed appropriate by the Investigator. However, it will be recommended that injections occur not 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

Official Title
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An Open Label Safety and Immunogenicity Study of MYOBLOC (Neurobloc; Botulinum Toxin Type B) Injectable Solution in Patients With Cervical Dystonia

Conditions
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Cervical Dystonia

Intervention / Treatment
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* Biological: Botulinum Toxin Type B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Botulinum Toxin Type B|Eligible patients could receive injections of MYOBLOC once every 12 weeks. Total Dose could range from 5,000 Units up to 25,000 Units.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Session 1 - Time 0, 4 weeks post-injection compared to baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | Session 8 (84 Wks) - 4 weeks post-injection compared to baseline |