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

Spasmodic Torticollis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00549341
• Other study ID #: PT-ST-01
• Status: Completed
• Phase: Phase 1
• First received: October 23, 2007
• Last updated: March 25, 2016
• Start date: May 2006
• Est. completion date: March 2009

Study information

• Verified date: March 2016
• Source: Mentor Worldwide, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 2009
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dystonia
• Spasmodic Torticollis
• Torticollis

Intervention

Drug:
• Mentor Purified Toxin, Botulinum Toxn Type A, Purified Neurotoxin
100U vials, doses ranged from 50U-200U, single injection.

Other:
• Physiologic saline
Single injection.

Locations

Country	Name	City	State
United States	Mentor Worldwide, LLC	Santa Barbara	California

Sponsors (1)

Lead Sponsor	Collaborator
Mentor Worldwide, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence of significant drug related adverse effects		Post-injection	Yes
Secondary	Decrease in symptom severity (TWSTRS)		30 days post-injection	No