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

NCT00549341 | Completed Phase 1

• 1 other identifier: PT-ST-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Torticollis; Cervical Dystonia

Outcome Measures

Primary Outcomes (1)

• Absence of significant drug related adverse effects

  Post-injection

Secondary Outcomes (1)

• Decrease in symptom severity (TWSTRS)

  30 days post-injection

Study Arms (2)

1

ACTIVE COMPARATOR

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

2

PLACEBO COMPARATOR

Other: Physiologic saline

Interventions

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

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

1

Physiologic saline OTHER

Single injection.

2

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Mentor Worldwide, LLC: lead

Study Sites (1)

Mentor Worldwide, LLC

Santa Barbara, California, 93111, United States

Location

MeSH Terms

Conditions

Torticollis

Condition Hierarchy (Ancestors)

Dystonia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Carolyn Austin

  Mentor Worldwide, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2007
• First Posted: October 25, 2007
• Study Start: May 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: March 1, 2009
• Last Updated: March 29, 2016

Record last verified: 2016-03

Locations

US (1)