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Effect of Levodopa on Human Multifocal Electroretinogram

NCT ID: NCT00812760

Last Updated: 2008-12-22

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

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-10-31

Study Completion Date

2003-10-31

Brief Summary

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It is known that dopamine is a functional neuromodulator at several levels of the visual system. Dopamine seems to be involved in the organization of the ganglion cell and the bipolar cell receptive fields and modulation of physiological activity of photoreceptors. There is evidence for the functional significance of dopaminergic modulation of visual sensitivity in humans which confirms the hypothesis that dopamine plays an important role in retinal light adaptation as well as in motion and contrast sensitivity function. The electrophysiological effects of dopamine, various dopamine antagonist and levodopa in animals and humans have been investigated by means of visual evoked potentials and electroretinograms. The multifocal ERG technique, developed by Sutter et al. allows a rapid, simultaneous recording of focal ERGs from multiple retinal locations. Although this technique is relatively new, it has already provided insights into the mechanisms of retinal diseases (e.g. involvement of visual system in Parkinson disease), but until now there is no data on influence of dopaminergic substances on mERG.

Detailed Description

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Conditions

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Retinal Diseases

Keywords

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Electroretinography levodopa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

levodopa

Intervention Type DRUG

1 tablet of 200 mg levodopa plus 50 mg benserazide

Interventions

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levodopa

1 tablet of 200 mg levodopa plus 50 mg benserazide

Intervention Type DRUG

Other Intervention Names

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Madopar

Eligibility Criteria

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Inclusion Criteria

* Men aged between 19 and 35 years, nonsmokers
* Body mass index between 15th and 85th percentile
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropia \< 3 Dpt

Exclusion Criteria

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
* History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with, distribution, metabolism or excretion of study drugs
* Blood donation during the previous 3 weeks
Minimum Eligible Age

19 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Department of Clinical Pharmacology, Medical University of Vienna

Principal Investigators

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Michael Wolzt, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Pharmacology, Medical University of Vienna

Locations

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Department of Clinical Pharmacology, Medical University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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OPHT-220501

Identifier Type: -

Identifier Source: org_study_id