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OpenTrials
Completed

NCT Number: NCT00712283

Investigate the Effect of Neramexane Mesylate IR Tablet on Driving Fitness and Capability to Operate Machines in Healthy Volunteers

Determination of the ability to drive and operate machines after single and multiple oral dose of Neramexane as compared to placebo

Completed

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Key information

Conditions

Healthy

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Merz Pharmaceuticals

Frankfurt am Main, 60318, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy volunteers, female and male
  • age 21 - 50
  • BMI 18 - 30 kg/m2
  • experienced drivers with a valid driver's license and at least 3 years of driving practice

Exclusion criteria

  • any clinically relevant finding on physical examination affecting the study objectives
  • clinically relevant abnormalities in the ECG laboratory values
  • history or present evidence of clinically relevant metabolic, renal, hepatic, pulmonary or cardiovascular disease, CNS disorders, or disturbance of bleeding diagnosis of malignancy
  • females who are pregnant or breastfeeding

Treatment and study plan

Neramexane mesylate

Drug

tablets Group A: duration: 12,5 mg for 7 days and 25 mg for 8 days Group B: duration: 25 mg for 7 days and 50 mg for 8 days Group C: duration: 50 mg for 7 days and 75 mg for 8 days Group D: duration: placebo for 15 days

Primary outcomes

  1. Fitness to drive

    Time frame: 15 days

Secondary outcomes

  1. Psychometric test and motor control tests

    Time frame: 15 days

Sponsors and collaborators

Lead sponsor

Merz Pharmaceuticals GmbH

Industry

Registry information

Official study title

A Single Center, Randomized, Double-blind, Placebo-controlled, Parallel Group Design Study to Investigate the Effect of 12,5 mg, 25 mg, 50 mg and 75 mg Neramexane Mesylate IR Tablet on Driving Fitness and Capability to Operate Machines in Healthy Volunteers

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 9, 2008
Registry last updated
Dec 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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