PurTox (Botulinum Toxin Type A) for the Treatment of Adult Onset Spasmodic Torticollis/Cervical Dystonia
Completed · Phase 1
Conditions studied: Spasmodic Torticollis
In brief
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.
Key facts
- Study ID
- NCT00549341
- Run by
- Mentor Worldwide, LLC
- People needed
- 70
- Starts
- 2006-05-01
- Expected to finish
- 2009-03-01
- Last updated by the study team
- 2016-03-29
Who can join
Age: 30 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Mentor Worldwide, LLC — Santa Barbara, California, United States
Full record on ClinicalTrials.gov
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