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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mentor Worldwide, LLC
ClinicalTrials.gov Identifier:
NCT00549341
First received: October 23, 2007
Last updated: September 1, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Spasmodic Torticollis
Drug: Mentor Purified Toxin, Botulinum Toxn Type A, Purified Neurotoxin
Other: Physiologic saline
Phase 1
Phase 2

Study Type: Interventional
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
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

Resource links provided by NLM:


Further study details as provided by Mentor Worldwide, LLC:

Primary Outcome Measures:
  • Absence of significant drug related adverse effects [ Time Frame: Post-injection ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Decrease in symptom severity (TWSTRS) [ Time Frame: 30 days post-injection ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: May 2006
Study Completion Date: March 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Mentor Purified Toxin, Botulinum Toxn Type A, Purified Neurotoxin
100U vials, doses ranged from 50U-200U, single injection.
Placebo Comparator: 2 Other: Physiologic saline
Single injection.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00549341

Locations
United States, California
Mentor Worldwide, LLC
Santa Barbara, California, United States, 93111
Sponsors and Collaborators
Mentor Worldwide, LLC
Investigators
Study Director: Carolyn Austin Mentor Worldwide, LLC
  More Information

No publications provided

Responsible Party: Mentor Worldwide, LLC
ClinicalTrials.gov Identifier: NCT00549341     History of Changes
Other Study ID Numbers: PT-ST-01
Study First Received: October 23, 2007
Last Updated: September 1, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Mentor Worldwide, LLC:
Torticollis
Cervical Dystonia

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Torticollis
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 21, 2014