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: May 23, 2014
Last verified: May 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Mentor Worldwide, LLC:
Torticollis
Cervical Dystonia

Additional relevant MeSH terms:
Dystonia
Torticollis
Central Nervous System Diseases
Dyskinesias
Dystonic Disorders
Movement Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Botulinum Toxins
Anti-Dyskinesia Agents
Central Nervous System Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014