Nystagmus, CongenitalPhase 2NCT00799942
Open-lable Extension Study on Safety and Efficacy of Neramexane to Treat Congenital and Acquired Nystagmus
A Phase 2 study testing Neramexane mesylate in people with Nystagmus, Congenital and Nystagmus, Acquired, run by Merz Pharmaceuticals GmbH at 1 site in United Kingdom.
Trial summary
The purpose of this study is to investigate the long-term safety, tolerability and efficacy of neramexane mesylate in the treatment of congenital idiopathic nystagmus (CIN). In addition, a subgroup of multiple sclerosis (MS) patients suffering from acquired nystagmus will be included. Read more about this study
- Who is it for?
- Ages 18 to 81 years
- Conditions the study is for
- Nystagmus, Congenital, Nystagmus, Acquired, Multiple Sclerosis
- What is being tested?
- Neramexane mesylate
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2009to not given
- Phase
- Phase 2
- 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 18 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who has succesfully completed the lead-in study MRZ 92579-0707/1
Who cannot join
- Occurence of any major treatment-emergent adverse event or condition during the previous protocol (MRZ 92579-0707/1)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Leicester, Leicester Royal Infirmary, Ophthalmology Group
Leicester, LE2 7LX
About this study
Official title: Long-term Open-label Extension Study to Assess the Safety, Tolerability, and Efficacy of Neramexane Mesylate in Congenital Idiopathic Nystagmus and Acquired Nystagmus
The purpose of this study is to investigate the long-term safety, tolerability and efficacy of neramexane mesylate in the treatment of congenital idiopathic nystagmus (CIN). In addition, a subgroup of multiple sclerosis (MS) patients suffering from acquired nystagmus will be included.
- Being tested
- Neramexane mesylate
- Keywords
- Nystagmus, congenital idiopathic
- Medical subject headings
- Nystagmus, Congenital, Nystagmus, Pathologic, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neramexane mesylateDrug
open-label treatment of 36 months Neramexane mesylate up to 75 mg per day
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term safety, Visual acuity
Measured: Baseline, week 4, month 3, 6, 9, 12, 18, 24, 30, 36 and follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2008 (estimated)
- Study startMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nystagmus, CongenitalStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00799942
- Sponsor's protocol ID
- MRZ 92579-0738/1
- Other IDs
- 2007-007663-25
- Status last verified
- Jun 2010
- First submitted
- 27 Nov 2008
- Last updated
- 1 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Open-label Extension Study to Assess the Safety, Tolerability, and Efficacy of Neramexane Mesylate in Congenital Idiopathic Nystagmus and Acquired Nystagmus
- ClinicalTrials.gov ID
- NCT00799942
- Acronym / sponsor ID
- MRZ 92579-0738/1
- Keywords
- Nystagmus, congenital idiopathic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Merz Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- May 2009
- First posted
- 1 Dec 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.
The purpose of this study is to investigate the long-term safety, tolerability and efficacy of neramexane mesylate in the treatment of congenital idiopathic nystagmus (CIN). In addition, a subgroup of multiple sclerosis (MS) patients suffering from acquired nystagmus will be included.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who has succesfully completed the lead-in study MRZ 92579-0707/1
Key exclusion criteria (1 listed)
- Occurence of any major treatment-emergent adverse event or condition during the previous protocol (MRZ 92579-0707/1)
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 mesylateopen-label treatment of 36 months Neramexane mesylate up to 75 mg per day | Drug | – |
Primary outcome
Long-term safety, Visual acuity
Time frame: Baseline, week 4, month 3, 6, 9, 12, 18, 24, 30, 36 and follow-up
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2010.
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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 2 study testing Neramexane mesylate in people with Nystagmus, Congenital and Nystagmus, Acquired, run by Merz Pharmaceuticals GmbH at 1 site in United Kingdom.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 1 Jul 2010. 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 United Kingdom. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early. Results are not available in the source record.
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?
Long-term safety, Visual acuity (time frame: Baseline, week 4, month 3, 6, 9, 12, 18, 24, 30, 36 and follow-up). 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 1 Jul 2010.