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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:
ClinicalTrials.gov Identifier:
NCT00712283
First Posted: July 9, 2008
Last Update Posted: December 7, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Merz Pharmaceuticals GmbH
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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:
  • Fitness to drive [ Time Frame: 15 days ]

Secondary Outcome Measures:
  • Psychometric test and motor control tests [ Time Frame: 15 days ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00712283


Locations
Germany
Merz Pharmaceuticals
Frankfurt/Main, Germany, 60318
Sponsors and Collaborators
Merz Pharmaceuticals GmbH
  More Information

Responsible Party: Merz Pharmaceuticals, Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT00712283     History of Changes
Other Study ID Numbers: MRZ 92579-0628/1
First Submitted: July 3, 2008
First Posted: July 9, 2008
Last Update Posted: December 7, 2009
Last Verified: December 2009

Keywords provided by Merz Pharmaceuticals GmbH:
fitness to drive
operate machines
To determine the fitness to drive and operate machines.