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

March 25, 2016 updated by: Mentor Worldwide, LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Barbara, California, United States, 93111
        • Mentor Worldwide, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Other: Physiologic saline
Single injection.
Active Comparator: 1
Drug: Mentor Purified Toxin, Botulinum Toxn Type A, Purified Neurotoxin
100U vials, doses ranged from 50U-200U, single injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Absence of significant drug related adverse effects
Time Frame: Post-injection
Post-injection

Secondary Outcome Measures

Outcome Measure
Time Frame
Decrease in symptom severity (TWSTRS)
Time Frame: 30 days post-injection
30 days post-injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mentor Worldwide, LLC

Investigators

  • Study Director: Carolyn Austin, Mentor Worldwide, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

October 23, 2007

First Submitted That Met QC Criteria

October 23, 2007

First Posted (Estimate)

October 25, 2007

Study Record Updates

Last Update Posted (Estimate)

March 29, 2016

Last Update Submitted That Met QC Criteria

March 25, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PT-ST-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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