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:
  • Fitness to drive [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Merz Pharmaceuticals
Frankfurt/Main, Germany, 60318
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 July 28, 2014