Effect of Clemastine Fumarate on Color Vision in Healthy... | NCT02613091

Studies
Effect of Clemastine Fumarate on Color Vision in Healthy Controls

NCT02613091

Sponsor

University of California, San Francisco

Status

Completed

Last Update Posted

Nov 3, 2016Estimated

Enrollment

23Actual

Phase

Phase 1

Conditions

Healthy Subjects

Interventions

Clemastine fumarate

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

Nov 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

Apr 2016

Primary Completion Date

Sep 2016Actual

Completion Date

Not provided

First Submitted Date

Oct 23, 2015

First Submission Date that Met QC Criteria

Nov 20, 2015

First Posted Date

Nov 24, 2015Estimated

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

Nov 2, 2016

Last Update Posted Date

Nov 3, 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

In a1972 study in the French Annals of Pharmaceuticals, Laroche and Laroche reported that the drug clemastine has a negative effect on patients' color discrimination, which is the ability to distinguish different hues and arrange them in the correct order. In an upcoming clinical trial studying the effect of clemastine on vision outcomes, our lab aims to assess color visual performance adding assessment of color defectiveness as a clinical endpoint. Color defectiveness is the ability to see certain colors, and is commonly referred to as color-blindness. Color discrimination and defectiveness can be related, but do not always correlate. This study aims to detect the effect, if any, that clemastine has on color defectiveness in healthy controls, which could confound its use as an outcome endpoint in future clinical trials relating to clemastine.

Detailed Description

Additional evaluation of pharmacokinetic data will be performed to confirm pharmacokinetic measures and correlate blood levels of drug to color performance if seen.

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

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Clemastine	Experimental	This group will receive 8mg of clemastine daily.	Drug: Clemastine fumarate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clemastine fumarate	Drug	4mg 2x day clemastine fumarate orally.	Clemastine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline cone contrast test score at 3 weeks	Cone contrast and color vision testing to be performed at all 3 study visits	baseline, 3 day, 3 week

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline Lanthany D15 score at 3 weeks	Lanthany D15 test to be administered at all 3 study visits. Score determined by number of "crossings" as outlined in the following link http://www.richmondproducts.com/files/8113/1550/0538/FR\_15\_Farnsworth\_and\_LanthonyD15\_Instructions\_Rev\_1.7\_0506.pdf	baseline, 3 day, 3 week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy control

Exclusion Criteria:

Preexisting ophthalmologic conditions such as optic neuritis, macular star, glaucoma

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ari Green, MD, MCR	UC San Francisco	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sandler Neurosciences Building, Neurological Clinical Research Unit		San Francisco	California	94107	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Background	Laroche. Modification of color vision elicited by the use of normal therapeutical dosage of some drugs. French Annals of Pharmaceuticals. 1972.

ID	Term
D011759	Pyrrolidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds