Use of Botox in the Management of Thyroid Related Upper E... | NCT01272414

Studies
Use of Botox in the Management of Thyroid Related Upper Eyelid Retraction

NCT01272414

Sponsor

University of Toronto

Status

Withdrawn

Last Update Posted

Jun 3, 2015Estimated

Enrollment

0Actual

Phase

Phase 4

Conditions

Graves Ophthalmopathy

Interventions

Botulinum Toxin Type A
Saline injection

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

Dec 2010

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

lack of funding

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Jan 2012Estimated

Completion Date

Feb 2012Actual

First Submitted Date

Jan 6, 2011

First Submission Date that Met QC Criteria

Jan 6, 2011

First Posted Date

Jan 7, 2011Estimated

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

Jun 2, 2015

Last Update Posted Date

Jun 3, 2015Estimated

Name	Class
Allergan	INDUSTRY

Description Module

Brief Summary

Currently there are few therapeutic options for the treatment of lid retraction secondary to thyroid orbitopathy (TO) during the active stages of the disease. BoTox injection is capable of creating a ptosis, that in the setting of TO can return the upper lid to a more physiologic position, thus improving cosmesis, corneal lubrication and potentially quiescent stage lid position. This investigation aims to examine the properties of this relationship.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BoTox Treatment	Experimental	Subjects receive BoTox injection to levator complex	Drug: Botulinum Toxin Type A
Saline injection	Placebo Comparator	Saline injection to levator complex	Drug: Saline injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Botulinum Toxin Type A	Drug	2-12 units in weekly 2u doses to effect	BoTox Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction in upper lid retraction (in mm)		4 month

Secondary Outcomes

Measure	Description	Time Frame
Subjective improvement in lid retraction related dry eye symptoms	ocular surface disease index score	4 months
Subjective improvement in lid retraction related cosmesis	Graves Orbitopathy quality of life score

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Active stage thyroid orbitopathy, as determined by symptom onset of under 6 months.
Upper eyelid retraction of 1mm or greater.
Complaining of either significant ocular symptoms (despite appropriate use of ocular lubricants), or bothered by the cosmetic deformity associated with the eyelid retraction.

Exclusion Criteria:

Less than 18 years of age
Age over 65 years
Pregnant or nursing
Known peripheral neuropathy or neuromuscular junction disorder
Demonstrated allergy to BoTox
Current infection over the injection site
Are currently taking any of the following medications: aminoglycosides, penicillamine, quinine, and calcium channel blockers.
Previous or concurrent prednisone therapy
Undergone previous upper eyelid surgery
Severe vision threatening TO

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniel B Rootman, MSc MD	University of Toronto	Principal Investigator
Nancy Tucker, MD FRCSC	University of Toronto	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mount Sinai Hospital		Toronto	Ontario	M5G 1X5	Canada

Condition Browse Module

MeSH Terms

ID	Term
D049970	Graves Ophthalmopathy

Ancestor Terms

ID	Term
D015785	Eye Diseases, Hereditary
D005128	Eye Diseases
D006111	Graves Disease
D005094	Exophthalmos

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019274	Botulinum Toxins, Type A
D012965	Sodium Chloride

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided