A Retrospective Chart Review of BOTOX® and Xeomin® for th... | NCT02245958

Studies
A Retrospective Chart Review of BOTOX® and Xeomin® for the Management of Cervical Dystonia and Blepharospasm

NCT02245958

Sponsor

Allergan

Status

Completed

Last Update Posted

Jan 8, 2016Estimated

Enrollment

44Actual

Phase

Not provided

Conditions

Cervical Dystonia
Blepharospasm

Interventions

No Intervention

Countries

Mexico
United Kingdom

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

Jan 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

Aug 2015

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Sep 18, 2014

First Submission Date that Met QC Criteria

Sep 18, 2014

First Posted Date

Sep 22, 2014Estimated

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

Jan 6, 2016

Last Update Posted Date

Jan 8, 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

This study is a retrospective chart review to evaluate the doses of botulinum Type A toxins BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used for the treatment of Cervical Dystonia and Blepharospasm in clinical practice.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BOTOX®		Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.	Other: No Intervention
Xeomin®		Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.	Other: No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No Intervention	Other	No treatment (intervention) was administered.	BOTOX® Xeomin®

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dose of Botulinum Toxin Used to Treat Cervical Dystonia		4 Years
Dose of Botulinum Toxin Used to Treat Blepharospasm		4 Years

Secondary Outcomes

Measure	Description	Time Frame
Botulinum Toxin Inter-injection Intervals		4 Years
Number of Participants with Adverse Events		4 Years
Annual Botulinum Toxin Dose per Patient

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Confirmed primary diagnosis of idiopathic cervical dystonia or blepharospasm for at least 2 years
Treatment with Xeomin® and BOTOX® for at least 2 years each.

Exclusion Criteria:

Having a neuromuscular junction transmission disorder or taking any medications that could affect neuromuscular junction transmission
Previous surgical procedure involving bone or muscle for the management of cervical dystonia or blepharospasm.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Participants with cervical dystonia or blepharospasm previously treated with Xeomin® and BOTOX® in clinical practice.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Medical Director	Allergan	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D014103	Torticollis
D001764	Blepharospasm

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Colonia Roma Z.P.		06700	Mexico