A Retrospective Study to Evaluate the Effectiveness of on... | NCT01749423

Studies
A Retrospective Study to Evaluate the Effectiveness of onabotulinumtoxinA in Preventing Headaches in Patients With Chronic Migraines

NCT01749423

Sponsor

Allergan

Status

Withdrawn

Last Update Posted

Feb 3, 2014Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Chronic Migraine, Headache

Interventions

OnabotulinumtoxinA

Countries

Not provided

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 2014

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Company decision due to enrollment challenges.

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Dec 2013Estimated

Completion Date

Dec 2013Estimated

First Submitted Date

Dec 12, 2012

First Submission Date that Met QC Criteria

Dec 12, 2012

First Posted Date

Dec 13, 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

Jan 31, 2014

Last Update Posted Date

Feb 3, 2014Estimated

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

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
All participants		Previous treatment with onabotulinumtoxinA for Chronic Migraine based on retrospective review of medical records.	Biological: OnabotulinumtoxinA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OnabotulinumtoxinA	Biological	Previous treatment with onabotulinumtoxinA for Chronic Migraine.	All participants

Measure	Description	Time Frame
Number of Headache Days		Up to 56 Weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

History of chronic migraines
15 or more headache days over a 30 day period
A minimum of 2 consecutive treatment cycles of 100 units onabotulinumtoxinA and a minimum of 2 consecutive treatment cycles with the onabotulinumtoxinA dosing between 155 and 195 units

Exclusion Criteria:

Any treatment cycle dose of onabotulinumtoxinA greater than 200 units

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Participants with chronic migraines who received a minimum of two consecutive treatment cycles of 100 units onabotulinumtoxinA and a minimum of two consecutive treatment cycles with the OnabotulinumtoxinA dosing between 155 and 195 units.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Medical Director	Allergan	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D006261	Headache

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, 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