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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

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ClinicalTrials.gov Identifier: NCT00702754
Recruitment Status : Completed
First Posted : June 20, 2008
Results First Posted : September 23, 2009
Last Update Posted : October 2, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
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

Condition or disease Intervention/treatment Phase
Cervical Dystonia Biological: Botulinum Toxin Type B Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 502 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Safety and Immunogenicity Study of MYOBLOC (Neurobloc; Botulinum Toxin Type B) Injectable Solution in Patients With Cervical Dystonia
Study Start Date : June 2001
Primary Completion Date : May 2008
Study Completion Date : September 2008


Arms and Interventions

Intervention Details:
    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.
    Other Name: MYOBLOC

Outcome Measures

Primary Outcome Measures :
  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 ]

Secondary Outcome Measures :
  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 ]
  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 ]
  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 ]
  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 ]
  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 ]
  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. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
More Information

Responsible Party: Sharon Reinhard, MS, Associate Director, Clinical Development, Solstice Neurosciences, Inc
ClinicalTrials.gov Identifier: NCT00702754     History of Changes
Other Study ID Numbers: 401CDNA
First Posted: June 20, 2008    Key Record Dates
Results First Posted: September 23, 2009
Last Update Posted: October 2, 2009
Last Verified: September 2009

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Torticollis
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
rimabotulinumtoxinB
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Anti-Dyskinesia Agents