Status:
COMPLETED
An Open Label Safety and Immunogenicity Study of MYOBLOC (Neurobloc; Botulinum Toxin Type B) Injectable Solution in Patients With Cervical Dystonia
Lead Sponsor:
Solstice Neurosciences
Conditions:
Cervical Dystonia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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. Du...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
502 Patients enrolled
Trial Details
Trial ID
NCT00702754
Start Date
June 1 2001
End Date
September 1 2008
Last Update
May 10 2019
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