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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00549341

Enrollment

Registered

2007-10-25

Start date

2006-05-31

Completion date

2009-03-31

Last updated

2016-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spasmodic Torticollis

Keywords

Torticollis, Cervical Dystonia

Brief 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.

Interventions

DRUGMentor Purified Toxin, Botulinum Toxn Type A, Purified Neurotoxin

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

OTHERPhysiologic saline

Single injection.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Absence of significant drug related adverse effects	Post-injection

Secondary

Measure	Time frame
Decrease in symptom severity (TWSTRS)	30 days post-injection

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026