Nystagmus, Congenital IdiopathicPhase 2NCT00661440
Efficacy and Safety Study of Neramexane to Treat Congenital and Acquired Nystagmus
A Phase 2 study testing Neramexane mesylate in people with Nystagmus, Congenital Idiopathic 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 safety and efficacy of neramexane mesylate in the treatment of congenital idiopathic nystagmus (CIN) in comparison to placebo. In addition, a subgroup of multiple sclerosis (MS) patients suffering from acquired nystagmus will be included; this subgroup will be analyzed… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nystagmus, Congenital Idiopathic, Nystagmus, Acquired
- What is being tested?
- Neramexane mesylate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2008to 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with congenital idiopathic nystagmus or acquired nystagmus subsequent to multiple sclerosis
- male or female outpatients
- aged between 18 and 80 years (inclusive) at screening
Who cannot join
- patients with evidence of neurologic disorders other than CIN such as congenital nystagmus due to albinism or retinal diseases and/or acquired nystagmus (exemption: secondary to MS)
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: Efficacy and Safety of Neramexane Mesylate in Congenital Idiopathic Nystagmus and Acquired Nystagmus: a Randomized, Double-blind, Placebo-controlled, Single Center, Proof of Concept Study Using a Two-period Cross-over Design
The purpose of this study is to investigate the safety and efficacy of neramexane mesylate in the treatment of congenital idiopathic nystagmus (CIN) in comparison to placebo. In addition, a subgroup of multiple sclerosis (MS) patients suffering from acquired nystagmus will be included; this subgroup will be analyzed in an exploratory manner only.
- Being tested
- Neramexane mesylate
- Medical subject headings
- Nystagmus, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neramexane mesylateDrug
Also called - verum, placebo, - placebo, verum
2 double-blind, cross-over treatment periods of 7 weeks separated by a wash-out phase, up to 75 mg Neramexane mesylate per day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Drug: Neramexane mesylate |
| 2 | Other | Not described Receives: Drug: Neramexane mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Measured: Screening, Baseline, Week 3, 7, 11, 14, 18, and Follow-up
Secondary outcomes (1)
nystagmus intensity, expanded nystagmus acuity function, reading ability, questionnaires, safety parameter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2008 (estimated)
- Study startMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nystagmus, Congenital IdiopathicStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Irene Gottlob, Prof., MD, Principal investigator, University of Leicester, Leicester, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00661440
- Sponsor's protocol ID
- MRZ 92579-0707/1
- Other IDs
- EudraCT Number 2007-002595-34
- Status last verified
- Nov 2009
- First submitted
- 15 Apr 2008
- Last updated
- 26 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Neramexane Mesylate in Congenital Idiopathic Nystagmus and Acquired Nystagmus: a Randomized, Double-blind, Placebo-controlled, Single Center, Proof of Concept Study Using a Two-period Cross-over Design
- ClinicalTrials.gov ID
- NCT00661440
- Acronym / sponsor ID
- MRZ 92579-0707/1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Merz Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- May 2008
- First posted
- 18 Apr 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 safety and efficacy of neramexane mesylate in the treatment of congenital idiopathic nystagmus (CIN) in comparison to placebo. In addition, a subgroup of multiple sclerosis (MS) patients suffering from acquired nystagmus will be included; this subgroup will be analyzed in an exploratory manner only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: Neramexane mesylate |
| 2 | Other | Drug: Neramexane mesylate |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with congenital idiopathic nystagmus or acquired nystagmus subsequent to multiple sclerosis
- male or female outpatients
- aged between 18 and 80 years (inclusive) at screening
Key exclusion criteria (1 listed)
- patients with evidence of neurologic disorders other than CIN such as congenital nystagmus due to albinism or retinal diseases and/or acquired nystagmus (exemption: secondary to MS)
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 mesylateAlso: - verum, placebo, - placebo, verum2 double-blind, cross-over treatment periods of 7 weeks separated by a wash-out phase, up to 75 mg Neramexane mesylate per day | Drug | 1, 2 |
Primary outcome
Visual acuity
Time frame: Screening, Baseline, Week 3, 7, 11, 14, 18, and Follow-up
1 secondary outcome
nystagmus intensity, expanded nystagmus acuity function, reading ability, questionnaires, safety parameter
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 26 Nov 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.
Irene Gottlob, Prof., MD principal investigator
University of Leicester, Leicester, United Kingdom
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 Idiopathic 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 3 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: finished, as of the sponsor's last update on 26 Nov 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 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 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?
Visual acuity (time frame: Screening, Baseline, Week 3, 7, 11, 14, 18, 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 26 Nov 2009.