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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2009-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Spasmodic Torticollis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Mentor Purified Toxin, Botulinum Toxn Type A, Purified Neurotoxin

Intervention Type DRUG

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

2

Group Type PLACEBO_COMPARATOR

Physiologic saline

Intervention Type OTHER

Single injection.

Interventions

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Mentor Purified Toxin, Botulinum Toxn Type A, Purified Neurotoxin

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

Intervention Type DRUG

Physiologic saline

Single injection.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No