Phase 4 N=502 Treatment

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

Cervical Dystonia

Bottom Line

View on ClinicalTrials.gov: NCT00702754 ↗

Enrolled (actual)

502

Serious AEs

—

Results posted

Sep 2009

Primary outcome: Primary: Treatment Assessment Scale (TAS), 4 Wks Post-injection Compared to Baseline (Time 0), Rating of Cervical Dystonia Symptoms — 0.9 points on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Botulinum Toxin Type B (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC
Primary completion: May 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Treatment Assessment Scale (TAS), 4 Wks Post-injection Compared to Baseline (Time 0), Rating of Cervical Dystonia Symptoms	0.9	—
SECONDARY Treatment Assessment Scale (TAS), Approx Wk 12 + 4 Wks Post-Injection Compared to Baseline. Rating of Cervical Dystonia Symptoms	1.3	—
SECONDARY Treatment Assessment Scale (TAS), Approx Wk 24 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms	1.5	—
SECONDARY Treatment Assessment Scale (TAS), Approx Wk 36 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms	1.4	—
SECONDARY Treatment Assessment Scale (TAS), Approx Wk 48 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms	1.5	—
SECONDARY Treatment Assessment Scale (TAS), Approx Wk 60 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms	1.4	—
SECONDARY Treatment Assessment Scale (TAS), Approx Wk 72 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms	1.5	—
SECONDARY Treatment Assessment Scale (TAS), Approx Wk 84 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms	1.4	—

Summary

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).

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00702754). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.