NCT00549341

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Mentor Worldwide, LLC · Industry
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spasmodic Torticollis

Interventions

Type	Name	Description
DRUG	Mentor Purified Toxin, Botulinum Toxn Type A, Purified Neurotoxin	100U vials, doses ranged from 50U-200U, single injection.
OTHER	Physiologic saline	Single injection.

Timeline

• Start date: 2006-05-01
• Primary completion: 2008-09-01
• Completion: 2009-03-01
• First posted: 2007-10-25
• Last updated: 2016-03-29

Locations

1 site across 1 country: United States