PurTox (Botulinum Toxin Type A) for the Treatment of Adult Onset Spasmodic Torticollis/Cervical Dystonia
| Status: | Completed |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 30 - 75 |
| Updated: | 4/21/2016 |
| Start Date: | May 2006 |
| End Date: | March 2009 |
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
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.
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.
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
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