NCT02613091

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 24, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Last Updated

November 3, 2016

Status Verified

November 1, 2016

Enrollment Period

5 months

First QC Date

October 23, 2015

Last Update Submit

November 2, 2016

Conditions

Healthy Subjects

Keywords

volunteers

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Change from baseline Lanthany D15 score at 3 weeks

    baseline, 3 day, 3 week

Study Arms (1)

Clemastine

EXPERIMENTAL

This group will receive 8mg of clemastine daily.

Drug: Clemastine fumarate

Interventions

Clemastine fumarateDRUG

4mg 2x day clemastine fumarate orally.

Clemastine

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy control

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sandler Neurosciences Building, Neurological Clinical Research Unit

San Francisco, California, 94107, United States

Location

Related Publications (1)

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

    BACKGROUND

MeSH Terms

Interventions

Clemastine

Intervention Hierarchy (Ancestors)

PyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Ari Green, MD, MCR

    UC San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MCR

Study Record Dates

First Submitted

October 23, 2015

First Posted

November 24, 2015

Study Start

April 1, 2016

Primary Completion

September 1, 2016

Last Updated

November 3, 2016

Record last verified: 2016-11

Locations

US(1)