NCT00712283

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jul 2008

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 9, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

December 7, 2009

Status Verified

December 1, 2009

Enrollment Period

8 months

First QC Date

July 3, 2008

Last Update Submit

December 4, 2009

Conditions

Healthy

Keywords

fitness to driveoperate machinesTo determine the fitness to drive and operate machines.

Outcome Measures

Primary Outcomes (1)

  • Fitness to drive

    15 days

Secondary Outcomes (1)

  • Psychometric test and motor control tests

    15 days

Study Arms (4)

D

PLACEBO COMPARATOR

healthy volunteers

Drug: Neramexane mesylate

C

ACTIVE COMPARATOR

healthy volunteers

Drug: Neramexane mesylate

B

ACTIVE COMPARATOR

healthy volunteers

Drug: Neramexane mesylate

A

ACTIVE COMPARATOR

healthy volunteers

Drug: Neramexane mesylate

Interventions

Neramexane mesylateDRUG

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

ABCD

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Merz Pharmaceuticals

Frankfurt am Main, 60318, Germany

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 3, 2008

First Posted

July 9, 2008

Study Start

July 1, 2008

Primary Completion

March 1, 2009

Study Completion

June 1, 2009

Last Updated

December 7, 2009

Record last verified: 2009-12

Locations

DE(1)