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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00549341
First Posted: October 25, 2007
Last Update Posted: March 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mentor Worldwide, LLC
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Decrease in symptom severity (TWSTRS) [ Time Frame: 30 days post-injection ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Mentor Worldwide, LLC
ClinicalTrials.gov Identifier: NCT00549341     History of Changes
Other Study ID Numbers: PT-ST-01
First Submitted: October 23, 2007
First Posted: October 25, 2007
Last Update Posted: March 29, 2016
Last Verified: March 2016

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
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs