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Effect of Levodopa on Human Multifocal Electroretinogram

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT00812760
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
24
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Levodopa on Human Multifocal Electroretinogram
Study Start Date :
Oct 1, 2001
Actual Primary Completion Date :
Oct 1, 2003
Actual Study Completion Date :
Oct 1, 2003

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Drug: levodopa
1 tablet of 200 mg levodopa plus 50 mg benserazide
Other Names:
  • Madopar

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Retinal activity (mERG amplitude) [5 measurements on both study days]

    Secondary Outcome Measures

    1. Retinal activity (mERG latency) [5 measurements on both study days]

    2. Dopamine and levodopa plasma levels [on both study days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 35 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Clinical Pharmacology, Medical University of Vienna Vienna Austria 1090

    Sponsors and Collaborators

    • Medical University of Vienna

    Investigators

    • Principal Investigator: Michael Wolzt, MD, Department of Clinical Pharmacology, Medical University of Vienna

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00812760
    Other Study ID Numbers:
    • OPHT-220501
    First Posted:
    Dec 22, 2008
    Last Update Posted:
    Dec 22, 2008
    Last Verified:
    Dec 1, 2008
    Keywords provided by , ,
    Electroretinography
    levodopa
    Additional relevant MeSH terms:
    Retinal Diseases
    Levodopa

    Study Results

    No Results Posted as of Dec 22, 2008