A Prospective, Observational Study of Patients With Cervi... | NCT01655862

Studies
A Prospective, Observational Study of Patients With Cervical Dystonia (Dystonie) Treated With OnabotulinumtoxinA

NCT01655862

Sponsor

Allergan

Status

Completed

Last Update Posted

Mar 30, 2017Actual

Enrollment

62Actual

Phase

Not provided

Conditions

Torticollis

Interventions

OnabotulinumtoxinA

Countries

Canada

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 2017

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

Jul 2012

Primary Completion Date

Feb 2017Actual

Completion Date

Feb 2017Actual

First Submitted Date

Jul 31, 2012

First Submission Date that Met QC Criteria

Jul 31, 2012

First Posted Date

Aug 2, 2012Estimated

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 28, 2017

Last Update Posted Date

Mar 30, 2017Actual

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 is an observational study to assess health-related quality of life in patients with cervical dystonia (dystonie) treated with OnabotulinumtoxinA per routine 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

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OnabotulinumtoxinA		OnabotulinumtoxinA injections at doses and frequencies as determined by the physician in accordance with clinical practice.	Biological: OnabotulinumtoxinA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OnabotulinumtoxinA	Biological	OnabotulinumtoxinA injections at doses and frequencies as determined by the physician in accordance with clinical practice.	OnabotulinumtoxinA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from Baseline in Cervical Dystonia Impact Profile Questionnaire (CDIP-58) Score		Baseline, 96 Weeks

Secondary Outcomes

Measure	Description	Time Frame
Patient's Global Impression of Change (PGIC) Using a 7-Point Scale		Baseline, 96 Weeks
Work Productivity Assessment Using a 10-Item Questionnaire		96 Weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of cervical dystonia (dystonie) and able to receive botulinum toxin Type A as deemed medically necessary by the physician

Exclusion Criteria:

Participation in a clinical trial for any botulinum toxin indication
Planning elective surgery during the observational study period
Treatment with any botulinum toxin product for cervical dystonia (dystonie)
Treatment with any botulinum toxin product for a non-cervical dystonia (dystonie) condition within 2 months of study start

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with Cervical Dystonia (Dystonie)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Goran Davidovic	Allergan	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinique Neuro-Rive Sud		Greenfield Park	Quebec	J4V 2J2	Canada
Hôpital Maisonneuve-Rosemont

Condition Browse Module

MeSH Terms

ID	Term
D014103	Torticollis

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019274	Botulinum Toxins, Type A

Ancestor Terms

ID	Term
D001905	Botulinum Toxins
D008666	Metalloendopeptidases
D010450	Endopeptidases
D010447	Peptide Hydrolases

Browse Leaves

Not provided

Browse Branches

Not provided