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Completed

NCT Number: NCT00549341

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

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.

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Key information

Conditions

Spasmodic Torticollis Dyskinesias Dystonia Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Torticollis

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mentor Worldwide, LLC

Santa Barbara, California, 93111, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mentor Purified Toxin, Botulinum Toxn Type A, Purified Neurotoxin

Drug

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

Physiologic saline

Other

Single injection.

Primary outcomes

  1. Absence of significant drug related adverse effects

    Time frame: Post-injection

Secondary outcomes

  1. Decrease in symptom severity (TWSTRS)

    Time frame: 30 days post-injection

Sponsors and collaborators

Lead sponsor

Mentor Worldwide, LLC

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Oct 25, 2007
Registry last updated
Mar 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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