Back to resultsPurTox (Botulinum Toxin Type A) for the Treatment of Adult Onset Spasmodic Torticollis/Cervical Dystonia
Primary Purpose
Spasmodic Torticollis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Mentor Purified Toxin, Botulinum Toxn Type A, Purified Neurotoxin
Physiologic saline
Sponsored by
About this trial
This is an interventional treatment trial for Spasmodic Torticollis focused on measuring Torticollis, Cervical Dystonia
Eligibility 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
Sites / Locations
- Mentor Worldwide, LLC
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Absence of significant drug related adverse effects
Secondary Outcome Measures
Decrease in symptom severity (TWSTRS)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00549341
Brief Title
PurTox (Botulinum Toxin Type A) for the Treatment of Adult Onset Spasmodic Torticollis/Cervical Dystonia
Official Title
A Phase I, Single-dose, Double-blind, Placebo Controlled, Dose Escalation Study to Evaluate the Safety of PurTox for the Treatment of Adult Onset Spasmodic Torticollis/Cervical Dystonia and to Explore Dose-associated Efficacy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mentor Worldwide, LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spasmodic Torticollis
Keywords
Torticollis, Cervical Dystonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Mentor Purified Toxin, Botulinum Toxn Type A, Purified Neurotoxin
Intervention Description
100U vials, doses ranged from 50U-200U, single injection.
Intervention Type
Other
Intervention Name(s)
Physiologic saline
Intervention Description
Single injection.
Primary Outcome Measure Information:
Title
Absence of significant drug related adverse effects
Time Frame
Post-injection
Secondary Outcome Measure Information:
Title
Decrease in symptom severity (TWSTRS)
Time Frame
30 days post-injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn Austin
Organizational Affiliation
Mentor Worldwide, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Mentor Worldwide, LLC
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93111
Country
United States
12. IPD Sharing Statement
Learn more about this trial
PurTox (Botulinum Toxin Type A) for the Treatment of Adult Onset Spasmodic Torticollis/Cervical Dystonia
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