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

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ClinicalTrials.gov Identifier: NCT00712283
Recruitment Status : Completed
First Posted : July 9, 2008
Last Update Posted : December 7, 2009
Sponsor:
Information provided by:
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

Condition or disease Intervention/treatment Phase
Healthy Drug: Neramexane mesylate Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
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
Study Start Date : July 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : June 2009

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




Primary Outcome Measures :
  1. Fitness to drive [ Time Frame: 15 days ]

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


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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

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

Responsible Party: Merz Pharmaceuticals, Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT00712283     History of Changes
Other Study ID Numbers: MRZ 92579-0628/1
First Posted: July 9, 2008    Key Record Dates
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.