Trial | NCT00549341  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    70
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.
Study Started
May 31
2006
Primary Completion
Sep 30
2008
Study Completion
Mar 31
2009
Last Update
Mar 29
2016
Estimate

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

100U vials, doses ranged from 50U-200U, single injection.

Other Physiologic saline

Single injection.

1 Active Comparator

2 Placebo Comparator

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
No Results Posted