NCT00999284

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 1996

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1996

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 1998

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 1998

Completed
11.6 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2009

Completed
Last Updated

October 21, 2009

Status Verified

October 1, 2009

Enrollment Period

1.3 years

First QC Date

October 20, 2009

Last Update Submit

October 20, 2009

Conditions

Visual Acuity

Keywords

ZK200775 is tested for its effects on vision on healthy probands.

Outcome Measures

Primary Outcomes (1)

  • Visual acuity

Secondary Outcomes (1)

  • Color vision (Panel D-15 test), dark vision (adaptometer), full-field electroretinogram

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Sham infusion of sodium chloride 0.9%

Drug: Sodium Chloride

Low dose arm

ACTIVE COMPARATOR

Infusion of 0.3 mg/kg/h ZK200775 over 4 hours

Drug: ZK200775

High dose arm

ACTIVE COMPARATOR

Infusion of 0.75 mg/kg/h ZK200775 over 4 hours

Drug: ZK200775

Interventions

ZK200775DRUG

Intravenous infusion of 0.3 mg/kg/h of ZK200775 over a period of 4 hours.

Low dose arm
Sodium ChlorideDRUG

Intravenous infusion of sodium chloride over a period of 4 hours.

Placebo

Eligibility Criteria

Age55 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The participant must be a voluntary proband
  • Age between 55 and 65 years
  • Body weight must not exceed the following value: Body height in cm minus 100 = body weight \[kg\] +/- 20%
  • Male sex
  • Written informed consent
  • Physical examination: Probands must show normal findings without clinical relevance, mental and physical health is required;

You may not qualify if:

  • Clinical history:
  • Substantial pre-existing medical condition
  • Known allergy to the employed effective components or galenic components
  • Medicaments and drugs
  • Intake of systemically or locally acting drugs which conflict with the aim of the trial or that can influence the results (antipsychotic drugs, antidepressants, barbiturates and benzodiazepines)
  • A clinical history that hints to substance or alcohol abuse
  • Nicotine abuse of more than 10 cigarettes a day
  • Consumption of alcoholic beverages on the day prior to the examinations
  • Extreme physical stress (sports or work) within 8 days prior to the examinations
  • Blood donation within 2 months prior to the examinations
  • Relevant vaccination or stay abroad
  • Special or onesided alimentation (strict vegetarianism, low-caloric diet)
  • Simultaneous participation in another clinical trial
  • Vital signs (after 3 minutes of rest)
  • Blood pressure with systolic values \> 160 mmHg and / or diastolic values \> 95 mmHg
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité Unviversitätsmedizin Berlin, Augenklinik Campus Virchow-Klinikum

Berlin, State of Berlin, 13353, Germany

Location

Related Publications (1)

  • 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.

    PMID: 20711429DERIVED

MeSH Terms

Interventions

ZK 200775Sodium Chloride

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Thomas Staks, Dr.

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 20, 2009

First Posted

October 21, 2009

Study Start

December 1, 1996

Primary Completion

April 1, 1998

Study Completion

April 1, 1998

Last Updated

October 21, 2009

Record last verified: 2009-10

Locations

DE(1)