NCT00999284|CompletedPhase 1DMC
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Sponsor study identifier
interventional
18
1 country
1
Study Start
December 1996
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 1998
Actual (reported)Study Completion
April 1998
Actual (reported)ZK 200775 is an antagonist at the α-Amino-3-hydroxy-5-methyl-4-isoxazolepropionate (AMPA) receptor and had earned attention a possible neuroprotective agent in cerebral ischemia. Probands receiving the agent within a stroke therapy related Phase I trial reported on an alteration of visual perception. In this trial, the effects of ZK 200775 on the visual system will be analyzed in detail. In a randomised, placebo-controlled, double-blind study eyes and vision will be examined before and after the intravenous administration of ZK 200775. The following methods will be applied: clinical examination, visual acuity, ophthalmoscopy, colour vision, rod absolute threshold, central visual field, pattern-reversal visual evoked potentials (pVEP), ON-OFF and full-field electroretinogram (ERG).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 1998
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 1996
Date type not reportedThis date has not been verified as actual or estimated.
April 1998
Actual (reported)April 1998
Actual (reported)October 20, 2009
Actual (reported)October 21, 2009
Actual (reported)Visual acuity
Color vision (Panel D-15 test), dark vision (adaptometer), full-field electroretinogram
Sham infusion of sodium chloride 0.9%
Infusion of 0.3 mg/kg/h ZK200775 over 4 hours
Infusion of 0.75 mg/kg/h ZK200775 over 4 hours
Intravenous infusion of 0.3 mg/kg/h of ZK200775 over a period of 4 hours.
Intravenous infusion of 0.75 mg/kg/h of ZK200775 over a period of 4 hours.
Charité Unviversitätsmedizin Berlin, Augenklinik Campus Virchow-Klinikum
Berlin, State of Berlin, 13353, Germany
Bergholz R, Staks T, Ruther K. Effects of the AMPA antagonist ZK 200775 on visual function: a randomized controlled trial. PLoS One. 2010 Aug 12;5(8):e12111. doi: 10.1371/journal.pone.0012111.
Thomas Staks, Dr.
Bayer
18 participants (actual enrollment reported by the registry).
First Submitted
October 20, 2009
First Posted
October 21, 2009
Study Start
December 1996
Date type not reportedThis date has not been verified as actual or estimated.
Performance Evaluation of DIY Digital Visual Acuity Test
Intravenous infusion of sodium chloride over a period of 4 hours.
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Primary Completion
April 1998
Actual (reported)Study Completion
April 1998
Actual (reported)Last Updated
October 21, 2009
Record last verified: 2009-10
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Source: ClinicalTrials.gov.
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