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

Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC

Status and phase

Completed

Phase 4

Conditions

Cervical Dystonia

Treatments

Biological: Botulinum Toxin Type B

Study type

Interventional

Funder types

Industry

Identifiers

NCT00702754

AN072-401CD/NA

Details and patient eligibility

About

Open label study to evaluate the safety and immunogenicity of MYOBLOC (Botulinum Toxin Type B) in adult patients with a clinical diagnosis of Cervical Dystonia (CD).

Full description

This is an open-label study aimed to assess long-term safety and immunogenicity of MYOBLOC (Botulinum Toxin Type B) in adult patients with a clinical diagnosis of Cervical Dystonia (CD). Up to 500 adult patients with a confirmed clinical diagnosis of 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 every 12 weeks when deemed appropriate by the Investigator. Injections should not occur 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.

Enrollment

502 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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