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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

502 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Study Completion Date

2008-09-30

Brief Summary

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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

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Detailed Description

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Conditions

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Cervical Dystonia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type BIOLOGICAL

Other Intervention Names

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MYOBLOC

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No