CompletedPhase 4

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

502 participantsStarted 2001-06

Plain-language 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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Trial details

NCT IDNCT00702754

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

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-05

Results submitted2009-05-12

View on ClinicalTrials.gov More Cervical Dystonia trials