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Effect of Clemastine Fumarate on Color Vision in Healthy Controls

NCT ID: NCT02613091

Last Updated: 2016-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Brief Summary

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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

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

Conditions

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Healthy Subjects

Keywords

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volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Clemastine

This group will receive 8mg of clemastine daily.

Group Type EXPERIMENTAL

Clemastine fumarate

Intervention Type DRUG

4mg 2x day clemastine fumarate orally.

Interventions

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Clemastine fumarate

4mg 2x day clemastine fumarate orally.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy control

Exclusion Criteria

* Preexisting ophthalmologic conditions such as optic neuritis, macular star, glaucoma
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Ari Green

MD, MCR

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ari Green, MD, MCR

Role: PRINCIPAL_INVESTIGATOR

UC San Francisco

Locations

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Sandler Neurosciences Building, Neurological Clinical Research Unit

San Francisco, California, United States

Site Status

Countries

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United States

References

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Laroche. Modification of color vision elicited by the use of normal therapeutical dosage of some drugs. French Annals of Pharmaceuticals. 1972.

Reference Type BACKGROUND

Other Identifiers

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Clemastine Color Vision

Identifier Type: -

Identifier Source: org_study_id