Effect of Levodopa on Human Multifocal Electroretinogram

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00812760
First received: December 18, 2008
Last updated: December 19, 2008
Last verified: December 2008

December 18, 2008
December 19, 2008
October 2001
October 2003   (final data collection date for primary outcome measure)
Retinal activity (mERG amplitude) [ Time Frame: 5 measurements on both study days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00812760 on ClinicalTrials.gov Archive Site
  • Retinal activity (mERG latency) [ Time Frame: 5 measurements on both study days ] [ Designated as safety issue: No ]
  • Dopamine and levodopa plasma levels [ Time Frame: on both study days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Levodopa on Human Multifocal Electroretinogram
Effect of Levodopa on Human Multifocal Electroretinogram

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Retinal Diseases
Drug: levodopa
1 tablet of 200 mg levodopa plus 50 mg benserazide
Other Name: Madopar
Experimental: 1
Intervention: Drug: levodopa
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
October 2003
October 2003   (final data collection date for primary outcome measure)

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
Male
19 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00812760
OPHT-220501
Not Provided
Michael Wolzt, Department of Clinical Pharmacology, Medical University of Vienna
Medical University of Vienna
Not Provided
Principal Investigator: Michael Wolzt, MD Department of Clinical Pharmacology, Medical University of Vienna
Medical University of Vienna
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP