NystagmusNCT00928954
Cross-over Comparison of Gabapentin and Memantine as Treatment for Acquired Nystagmus
A study testing gabapentin and memantine in people with Nystagmus, run by Case Western Reserve University at 1 site in United States.
Trial summary
Involuntary oscillations of the eyes (nystagmus) impairs vision so that affected patients, who have neurological disorders such as Multiple Sclerosis (MS) , cannot read or watch TV. Two medicines have been reported to suppress nystagmus and improve vision in such patients: gabapentin and memantine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nystagmus
- What is being tested?
- gabapentin and memantine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to May 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (18 years or older) males or females with acquired nystagmus that is degrading their vision
Who cannot join
- Pregnant women
- Individuals who cannot describe their visual symptoms, cooperate with testing, or give informed consent
- Individuals with intolerance of gabapentin or memantine
Trial locations and contacts
1 site in 1 country.
United States1 site
Veterans Affairs Medical Center, 10701 East Boulevard
Cleveland, Ohio, 44106
About this study
Official title: Investigation and Treatment of Ocular Motor Disorders: Cross-over Comparison of Gabapentin and Memantine as Treatment for Nystagmus
Involuntary oscillations of the eyes (nystagmus) impairs vision so that affected patients, who have neurological disorders such as Multiple Sclerosis (MS) , cannot read or watch TV. Two medicines have been reported to suppress nystagmus and improve vision in such patients: gabapentin and memantine. The investigators set out to test which of these two drug was more effective by carrying out a double-blind cross-over study. In this way, we could determine which drug worked best in each patient.
Read the detailed description
The study entails careful measurements of visual acuity and precise measurements of eye movements, using a contact lens device (magnetic search coil method). In this way, it is possible to make objective and reliable measurements of the effect of each drug, which are unbiased by the investigator or the patient.
- Conditions
- Nystagmus
- Being tested
- gabapentin, memantine
- Keywords
- gabapentin, memantine, nystagmus, Drug treatment
- Medical subject headings
- Nystagmus, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gabapentinDrug
Also called Neurontin
increasing to 1200 mg/day
memantineDrug
Also called Nameda
increasing to 40 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin | Active comparator | Increasing dose to 300 mg four times per day (total of 1200 mg/day) Receives: Drug: gabapentin |
| Memantine | Active comparator | Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day). Receives: Drug: memantine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in logMAR Visual Acuity of Each Eye, Measured During Far or Near Viewing
Measured: After 2 weeks of therapy, for both drugs
Percent Change in Median Eye Speed
Median eye speed during attempted visual fixation by each eye
Measured: After 2 weeks of therapy, for both drugs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2009 (estimated)
- Study startFeb 2005
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for NystagmusStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Leigh, Case Western Reserve University
- Investigators
- Richard J Leigh, MD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00928954
- Sponsor's protocol ID
- NIHR01EY06717
- Other IDs
- NIHR01EY06717, NIH R01 EYO6717
- Status last verified
- Jul 2016
- First submitted
- 25 Jun 2009
- Last updated
- 29 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation and Treatment of Ocular Motor Disorders: Cross-over Comparison of Gabapentin and Memantine as Treatment for Nystagmus
- ClinicalTrials.gov ID
- NCT00928954
- Acronym / sponsor ID
- NIHR01EY06717
- Conditions
- Nystagmus
- Keywords
- gabapentin, memantine, nystagmus, Drug treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Study start
- Feb 2005
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 26 Jun 2009 (estimated)
- Results
- Posted 29 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Involuntary oscillations of the eyes (nystagmus) impairs vision so that affected patients, who have neurological disorders such as Multiple Sclerosis (MS) , cannot read or watch TV. Two medicines have been reported to suppress nystagmus and improve vision in such patients: gabapentin and memantine. The investigators set out to test which of these two drug was more effective by carrying out a double-blind cross-over study. In this way, we could determine which drug worked best in each patient.
Detailed description
The study entails careful measurements of visual acuity and precise measurements of eye movements, using a contact lens device (magnetic search coil method). In this way, it is possible to make objective and reliable measurements of the effect of each drug, which are unbiased by the investigator or the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gabapentin | Active comparator | Drug: gabapentinIncreasing dose to 300 mg four times per day (total of 1200 mg/day) |
| Memantine | Active comparator | Drug: memantineIncreasing dose over two weeks to 20 mg twice/day (total of 40 mg/day). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult (18 years or older) males or females with acquired nystagmus that is degrading their vision
Key exclusion criteria (3 listed)
- Pregnant women
- Individuals who cannot describe their visual symptoms, cooperate with testing, or give informed consent
- Individuals with intolerance of gabapentin or memantine
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 |
|---|---|---|
| gabapentinAlso: Neurontinincreasing to 1200 mg/day | Drug | Gabapentin |
| memantineAlso: Namedaincreasing to 40 mg/day | Drug | Memantine |
Primary outcome
Change in logMAR Visual Acuity of Each Eye, Measured During Far or Near Viewing
Time frame: After 2 weeks of therapy, for both drugs
Percent Change in Median Eye Speed
Time frame: After 2 weeks of therapy, for both drugs
Median eye speed during attempted visual fixation by each eye
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Richard J Leigh, MD principal investigator
Case Western Reserve University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gabapentin and memantine in people with Nystagmus, run by Case Western Reserve University at 1 site in United States.
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 3 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 29 Jul 2016. 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 States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in logMAR Visual Acuity of Each Eye, Measured During Far or Near Viewing (time frame: After 2 weeks of therapy, for both drugs). The study lists 2 primary outcomes in all. 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 29 Jul 2016.