NCT00702754

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 502 (actual)
• Sponsor: Solstice Neurosciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Cervical Dystonia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2001-06-01
• Primary completion: 2008-05-01
• Completion: 2008-09-01
• First posted: 2008-06-20
• Last updated: 2019-05-10
• Results posted: 2009-09-23