PurTox (Botulinum Toxin Type A) for the Treatment of Adult Onset Spasmodic Torticollis/Cervical Dystonia

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mentor Worldwide, LLC
• Treatments: Botulinum Toxins

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