Effect of Levodopa on Human Multifocal Electroretinogram
| Tracking Information | |||||
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| First Received Date ICMJE | December 18, 2008 | ||||
| Last Updated Date | December 19, 2008 | ||||
| Start Date ICMJE | October 2001 | ||||
| Primary Completion Date | October 2003 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Retinal activity (mERG amplitude) [ Time Frame: 5 measurements on both study days ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00812760 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Levodopa on Human Multifocal Electroretinogram | ||||
| Official Title ICMJE | Effect of Levodopa on Human Multifocal Electroretinogram | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Retinal Diseases | ||||
| Intervention ICMJE | Drug: levodopa
1 tablet of 200 mg levodopa plus 50 mg benserazide
Other Name: Madopar |
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| Study Arm (s) | Experimental: 1
Intervention: Drug: levodopa |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 20 | ||||
| Completion Date | October 2003 | ||||
| Primary Completion Date | October 2003 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 19 Years to 35 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Austria | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00812760 | ||||
| Other Study ID Numbers ICMJE | OPHT-220501 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Michael Wolzt, Department of Clinical Pharmacology, Medical University of Vienna | ||||
| Study Sponsor ICMJE | Medical University of Vienna | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Medical University of Vienna | ||||
| Verification Date | December 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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