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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Neramexane mesylate

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Frankfurt/Main, Germany, 60318
    • Merz Pharmaceuticals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: D; healthy volunteers	Drug: Neramexane 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
Active Comparator: C; healthy volunteers	Drug: Neramexane 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
Active Comparator: B; healthy volunteers	Drug: Neramexane 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
Active Comparator: A; healthy volunteers	Drug: Neramexane 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Fitness to drive	15 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Psychometric test and motor control tests	15 days

Collaborators and Investigators

• Sponsor: Merz Pharmaceuticals GmbH

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: July 3, 2008
• First Submitted That Met QC Criteria: July 8, 2008
• First Posted (Estimate): July 9, 2008

Study Record Updates

• Last Update Posted (Estimate): December 7, 2009
• Last Update Submitted That Met QC Criteria: December 4, 2009
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: fitness to drive; operate machines; To determine the fitness to drive and operate machines.
• Other Study ID Numbers: MRZ 92579-0628/1