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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Neramexane mesylate

• Registration Number: NCT00712283
• Lead Sponsor: Merz Pharmaceuticals GmbH

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-03
• Study First Submitted QC: 2008-07-08
• Study First Posted: 2008-07-09
• Primary Completion: 2009-03
• Study Completion: 2009-06
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-04
• Last Update Posted: 2009-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Neramexane mesylate	healthy volunteers
A	Neramexane mesylate	healthy volunteers
D	Neramexane mesylate	healthy volunteers
C	Neramexane mesylate	healthy volunteers

Primary Outcome Measures

Name	Time	Method
Fitness to drive	15 days

Secondary Outcome Measures

Name	Time	Method
Psychometric test and motor control tests	15 days

Trial Locations

Locations (1)

Merz Pharmaceuticals; 🇩🇪 Frankfurt/Main, Germany