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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

This study has been completed.
Sponsor:
Information provided by:
Solstice Neurosciences
ClinicalTrials.gov Identifier:
NCT00702754
First received: June 12, 2008
Last updated: September 22, 2009
Last verified: September 2009
History of Changes
  Purpose

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 Intervention Phase
Cervical Dystonia
 Biological: Botulinum Toxin Type B
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Botox Dystonia
U.S. FDA Resources

Further study details as provided by Solstice Neurosciences:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 502
Study Start Date: June 2001
Study Completion Date: September 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Sharon Reinhard, MS, Associate Director, Clinical Development, Solstice Neurosciences, Inc
ClinicalTrials.gov Identifier: NCT00702754     History of Changes
Other Study ID Numbers: 401CDNA, 401CDNA
Study First Received: June 12, 2008
Results First Received: May 12, 2009
Last Updated: September 22, 2009
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013