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CompletedNCT00549341Updated Mar 29, 2016

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

A Phase 1 interventional study of Mentor Purified Toxin, Botulinum Toxn Type A, Purified Neurotoxin and Physiologic saline in Spasmodic Torticollis, sponsored by Mentor Worldwide, LLC. Completed at 1 site in United States. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-03-29.

Sponsored by Mentor Worldwide, LLC · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
30 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Spasmodic Torticollis

Keywords

  • Torticollis
  • Cervical Dystonia
03

In context

Dystonia

319 studies on the registry are indexed under Dystonia; 56 are open to participants now.

This study's enrollment of 70 is above the median of 32 across 181 interventional studies indexed under Dystonia.

Browse Dystonia studies →

Lead sponsor

Mentor Worldwide, LLC is the lead sponsor of 17 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
70 participants (actual)

Study arms

  • Active comparator
    1

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

  • Placebo comparator
    2

    Other: Physiologic saline

Interventions

  • DrugMentor Purified Toxin, Botulinum Toxn Type A, Purified Neurotoxin

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

  • OtherPhysiologic saline

    Single injection.

06

What researchers measure

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

07

Study locations

1 site
  • Mentor Worldwide, LLC
    Santa Barbara, California 93111, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00549341
Lead sponsor
Mentor Worldwide, LLC
Responsible party
Sponsor
First posted
Oct 25, 2007
Start date
May 2006
Primary completion
Sep 2008
Completion
Mar 2009
Last update
Mar 29, 2016

Study contacts

Carolyn Austin
study director · Mentor Worldwide, LLC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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