HealthyPhase 1NCT00712283
Investigate the Effect of Neramexane Mesylate IR Tablet on Driving Fitness and Capability to Operate Machines in Healthy Volunteers
A Phase 1 study testing Neramexane mesylate in people with Healthy, run by Merz Pharmaceuticals GmbH at 1 site in Germany.
Trial summary
Determination of the ability to drive and operate machines after single and multiple oral dose of Neramexane as compared to placebo Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Neramexane mesylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2008to Jun 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Determination of the ability to drive and operate machines after single and multiple oral dose of Neramexane as compared to placebo
- Conditions
- Healthy
- Being tested
- Neramexane mesylate
- Keywords
- fitness to drive, operate machines, To determine the fitness to drive and operate machines.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| D | Placebo comparator | healthy volunteers Receives: Drug: Neramexane mesylate |
| C | Active comparator | healthy volunteers Receives: Drug: Neramexane mesylate |
| B | Active comparator | healthy volunteers Receives: Drug: Neramexane mesylate |
| A | Active comparator | healthy volunteers Receives: Drug: Neramexane mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fitness to drive
Measured: 15 days
Secondary outcomes (1)
Psychometric test and motor control tests
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionMar 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00712283
- Sponsor's protocol ID
- MRZ 92579-0628/1
- Status last verified
- Dec 2009
- First submitted
- 3 Jul 2008
- Last updated
- 7 Dec 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00712283
- Acronym / sponsor ID
- MRZ 92579-0628/1
- Conditions
- Healthy
- Keywords
- fitness to drive, operate machines, To determine the fitness to drive and operate machines.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Merz Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 9 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determination of the ability to drive and operate machines after single and multiple oral dose of Neramexane as compared to placebo
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| D | Placebo comparator | Drug: Neramexane mesylatehealthy volunteers |
| C | Active comparator | Drug: Neramexane mesylatehealthy volunteers |
| B | Active comparator | Drug: Neramexane mesylatehealthy volunteers |
| A | Active comparator | Drug: Neramexane mesylatehealthy volunteers |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neramexane mesylatetablets 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 | Drug | A, B, C, D |
Primary outcome
Fitness to drive
Time frame: 15 days
1 secondary outcome
Psychometric test and motor control tests
Time frame: 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Neramexane mesylate in people with Healthy, run by Merz Pharmaceuticals GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fitness to drive (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2009.