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

Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC502 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

502

Conditions

Cervical Dystonia

Interventions

Botulinum Toxin Type BBIOLOGICAL

Eligible patients could receive injections of MYOBLOC once every 12 weeks. Total Dose could range from 5,000 Units up to 25,000 Units.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: Session 1 - Time 0, 4 weeks post-injection compared to baseline

Secondary Outcomes

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

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

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

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

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

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

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

Data from ClinicalTrials.gov

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