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

Phase 1

Completed

• Conditions: Spasmodic Torticollis
• Interventions: Other: Physiologic saline; Drug: Mentor Purified Toxin, Botulinum Toxn Type A, Purified Neurotoxin

• Registration Number: NCT00549341
• Lead Sponsor: Mentor Worldwide, LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2007-10-23
• Study First Submitted QC: 2007-10-23
• Study First Posted: 2007-10-25
• Primary Completion: 2008-09
• Study Completion: 2009-03
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-25
• Last Update Posted: 2016-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2	Physiologic saline	-
1	Mentor Purified Toxin, Botulinum Toxn Type A, Purified Neurotoxin	-

Primary Outcome Measures

Name	Time	Method
Absence of significant drug related adverse effects	Post-injection

Secondary Outcome Measures

Name	Time	Method
Decrease in symptom severity (TWSTRS)	30 days post-injection

Trial Locations

Locations (1)

Mentor Worldwide, LLC; 🇺🇸 Santa Barbara, California, United States