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

This study has been completed.

Sponsor:

Information provided by:

Merz Pharmaceuticals GmbH

ClinicalTrials.gov Identifier:

NCT00712283

First received: July 3, 2008

Last updated: December 4, 2009

Last verified: December 2009

Purpose

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

Condition	Intervention	Phase
Healthy	Drug: Neramexane mesylate	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official 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

Further study details as provided by Merz Pharmaceuticals GmbH:

Primary Outcome Measures:

Secondary Outcome Measures:

Psychometric test and motor control tests [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	64
Study Start Date:	July 2008
Study Completion Date:	June 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712283

Locations

Sponsors and Collaborators

Merz Pharmaceuticals GmbH

More Information

No publications provided

Responsible Party:	Merz Pharmaceuticals, Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:	NCT00712283 History of Changes
Other Study ID Numbers:	MRZ 92579-0628/1
Study First Received:	July 3, 2008
Last Updated:	December 4, 2009
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Merz Pharmaceuticals GmbH:

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

ClinicalTrials.gov processed this record on May 16, 2013