Clinical trial NCT00702754: An Open Label Safety and Immunogenicity Study of MYOBLOC (Neurobloc; Botulinum Toxin Type B) Injectable Solution in Patients With Cervical Dystonia
Official title: An Open Label Safety and Immunogenicity Study of MYOBLOC (Neurobloc; Botulinum Toxin Type B) Injectable Solution in Patients With Cervical Dystonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cervical Dystonia
Lead sponsor: USWM, LLC (dba US WorldMeds)
Sponsor class: INDUSTRY
First posted: 2008-06-20
Enrollment: 502
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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. 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


Eligibility 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

Primary outcomes:
measure: Treatment Assessment Scale (TAS), 4 Wks Post-injection Compared to Baseline (Time 0), Rating of Cervical Dystonia Symptoms
timeFrame: Session 1 - Time 0, 4 weeks post-injection compared to baseline
Secondary outcomes:
measure: Treatment Assessment Scale (TAS), Approx Wk 12 + 4 Wks Post-Injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
timeFrame: Session 2 (12 wks) - 4 weeks post-injection compared to baseline
measure: Treatment Assessment Scale (TAS), Approx Wk 24 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
timeFrame: Session 3 (24 Wks) - 4 weeks post-injection compared to baseline
measure: Treatment Assessment Scale (TAS), Approx Wk 36 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
timeFrame: Session 4 (36 Wks) - 4 weeks post-injection compared to baseline
measure: Treatment Assessment Scale (TAS), Approx Wk 48 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
timeFrame: Session 5 (48 Wks) - 4 weeks post-injection compared to baseline
measure: Treatment Assessment Scale (TAS), Approx Wk 60 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
timeFrame: Session 6 (60 Wks) - 4 weeks post-injection compared to baseline
measure: Treatment Assessment Scale (TAS), Approx Wk 72 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
timeFrame: Session 7 (72 Wks) - 4 weeks post-injection compared to baseline
measure: Treatment Assessment Scale (TAS), Approx Wk 84 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
timeFrame: Session 8 (84 Wks) - 4 weeks post-injection compared to baseline
Other outcomes:
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