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

NCT00549341 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2016-03-29

No results posted yet for this 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.

Conditions

  • Spasmodic Torticollis

Interventions

DRUG

Mentor Purified Toxin, Botulinum Toxn Type A, Purified Neurotoxin

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

OTHER

Physiologic saline

Single injection.

Sponsors & Collaborators

  • Mentor Worldwide, LLC

    lead INDUSTRY

Principal Investigators

  • Carolyn Austin · Mentor Worldwide, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2008-09-30
Completion
2009-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00549341 on ClinicalTrials.gov