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

Mentor Worldwide

Status and phase: Completed; Phase 1

Conditions: Spasmodic Torticollis

Treatments: Other: Physiologic saline; Drug: Mentor Purified Toxin, Botulinum Toxn Type A, Purified Neurotoxin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00549341

PT-ST-01

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Treatment:

Drug: Mentor Purified Toxin, Botulinum Toxn Type A, Purified Neurotoxin

2

Placebo Comparator group

Treatment:

Other: Physiologic saline