PurTox (Botulinum Toxin Type A) for the Treatment of Adul... | NCT00549341

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

NCT00549341

Sponsor

Mentor Worldwide, LLC

Status

Completed

Last Update Posted

Mar 29, 2016Estimated

Enrollment

70Actual

Phase

Phase 1

Conditions

Spasmodic Torticollis

Interventions

Mentor Purified Toxin, Botulinum Toxn Type A, Purified Neurotoxin
Physiologic saline

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2006

Primary Completion Date

Sep 2008Actual

Completion Date

Mar 2009Actual

First Submitted Date

Oct 23, 2007

First Submission Date that Met QC Criteria

Oct 23, 2007

First Posted Date

Oct 25, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2016

Last Update Posted Date

Mar 29, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator		Drug: Mentor Purified Toxin, Botulinum Toxn Type A, Purified Neurotoxin
2	Placebo Comparator		Other: Physiologic saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mentor Purified Toxin, Botulinum Toxn Type A, Purified Neurotoxin	Drug	100U vials, doses ranged from 50U-200U, single injection.	1

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

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D004421	Dystonia
D020820	Dyskinesias
D009461	Neurologic Manifestations
D012816	Signs and Symptoms