Expired Study
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Santa Barbara, California 93111


Purpose:

The safety and efficacy of Mentor Purified Toxin, Botulinum Toxin Type A, Purified Neurotoxin, injected intramuscularly into the neck, is being evaluated as a treatment for painful and non-painful spasmodic torticollis/cervical dystonia. It is hypothesized that treatment will decrease symptom severity and will not have any significant side effects.


Criteria:

Inclusion Criteria: - Diagnosis of torticollis with noticeable symptoms for at least 6 months - Total TWSTRS score greater or equal to 20, TWSTRS severity score greater than or equal to 10 and TWSTRS Disability score greater than or equal to 3 (must meet all 3 criteria) Exclusion Criteria: - Diagnosis of isolated anterocollis - Concurrent myopathic disease, myotonic dystrophy (or other form of muscular dystrophy), myasthenia gravis - Currently receiving aminoglycoside antibiotic therapy, curare-like drugs, quinidine, succinylcholine, polymixins, anticholinesterases, magnesium sulfate, or lincosamides - Any illness that is considered by the Investigator to make the subject an inappropriate candidate - Cervical spine injury within 18 months or head and neck surgery within 6 months prior to screening - Pre-existing dysphagia - History of active autoimmune disease - Exposure to botulinum toxin based pharmaceutical within 3 months prior to screening - History of primary non-response or secondary resistance with prior exposure to botulinum based pharmaceuticals - History of chemotherapy/radiation for malignant disease within 24 months - Any investigational drug/device during the 30 days prior to screening


NCT ID:

NCT00549341


Primary Contact:

Study Director
Carolyn Austin
Mentor Worldwide, LLC


Backup Contact:

N/A


Location Contact:

Santa Barbara, California 93111
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 17, 2017

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