An Open Label Safety and Immunogenicity Study of MYOBLOC (Neurobloc; Botulinum Toxin Type B) Injectable Solution in Patients With Cervical Dystonia
Information source: Solstice Neurosciences
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cervical Dystonia
Intervention: Botulinum Toxin Type B (Biological)
Phase: Phase 4
Status: Completed
Sponsored by: Solstice Neurosciences
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
Clinical Details
Official title: An Open Label Safety and Immunogenicity Study of MYOBLOC (Neurobloc; Botulinum Toxin Type B) Injectable Solution in Patients With Cervical Dystonia
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Treatment Assessment Scale (TAS), 4 Wks Post-injection Compared to Baseline (Time 0), Rating of Cervical Dystonia Symptoms
Secondary outcome: Treatment Assessment Scale (TAS), Approx Wk 12 + 4 Wks Post-Injection Compared to Baseline. Rating of Cervical Dystonia SymptomsTreatment Assessment Scale (TAS), Approx Wk 24 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms Treatment Assessment Scale (TAS), Approx Wk 36 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms Treatment Assessment Scale (TAS), Approx Wk 48 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms Treatment Assessment Scale (TAS), Approx Wk 60 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms Treatment Assessment Scale (TAS), Approx Wk 72 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms Treatment Assessment Scale (TAS), Approx Wk 84 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: June 2001
Last updated: September 22, 2009
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