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NCT Number: NCT00702754

Open Label Safety/Immunogenicity Study of MYOBLOC (Neurobloc; Botulinum Toxin Type B) 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).

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Key information

Conditions

Cervical Dystonia Dyskinesias Dystonia Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Torticollis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum Toxin Type B

Biological

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

Other names: MYOBLOC

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    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

  2. 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

    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

  3. 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

    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

  4. 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

    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

  5. 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

    7 point scale (-3=significantly worse, 0=no change, +3=significantly better). comparison Wk 60 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms

  6. 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

    7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison Wk 72 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms

  7. 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

    7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison Wk 84 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2008
Study completion
2008
First posted
Jun 20, 2008
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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