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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00712283

Enrollment

Registered

2008-07-09

Start date

2008-07-31

Completion date

2009-06-30

Last updated

2009-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

fitness to drive, operate machines, To determine the fitness to drive and operate machines.

Brief summary

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

Interventions

DRUGNeramexane mesylate

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Fitness to drive	15 days

Secondary

Measure	Time frame
Psychometric test and motor control tests	15 days

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026