An interventional study of gabapentin and memantine in Nystagmus, sponsored by Case Western Reserve University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-29.
Sponsored by Case Western Reserve University · Not applicable, Interventional, and Treatment
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.
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.
27 studies on the registry are indexed under Nystagmus, Pathologic; 3 are open to participants now.
This study's enrollment of 10 is below the median of 48 across 17 interventional studies indexed under Nystagmus, Pathologic.
Browse Nystagmus, Pathologic studies →Case Western Reserve University is the lead sponsor of 160 studies on the registry; 28 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Increasing dose to 300 mg four times per day (total of 1200 mg/day)
Drug: gabapentin
Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day).
Drug: memantine
increasing to 1200 mg/day
Also known as: Neurontin
increasing to 40 mg/day
Also known as: Nameda
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
Median eye speed during attempted visual fixation by each eye
Time frame: After 2 weeks of therapy, for both drugs
| Milestone | Gabapentin First and Then Memantine | Memantine First, Then Gabapentin |
|---|---|---|
| Started | 4 | 6 |
| Completed | 4 | 6 |
| Not completed | 0 | 0 |
| logMAR | Gabapentin | Memantine |
|---|---|---|
| Participant 1, Right Eye | 0 | 0.1 |
| Participant 1, Left Eye | 0.2 | 0.2 |
| Participant 2, Right Eye | 0.1 | 0.2 |
| Participant 2, Left Eye | 0.2 | 0 |
| Participant 3, RIght Eye | -0.1 | -0.2 |
| Participant 3, Left Eye | NA | NA |
| Patricipant 4, RIght Eye | 0.3 | -0.1 |
| Participant 4, Left Eye | 0.1 | 0.1 |
| Participant 5, Right Eye | 0.1 | 0.2 |
| Particpant 5, Left Eye | 0 | 0.1 |
| Particpant 6, RIght Eye | 0.4 | 0 |
| Particpant 6, Left Eye | 0.2 | 0.2 |
| Particpant 7, Right Eye | -0.1 | 0.1 |
| Particpant 7, Left Eye | 0.1 | 0.1 |
| Participant 8, Right Eye | 0.1 | 0 |
| Participant 8, Left Eye | 0 | 0.1 |
| Particpant 9, Right Eye | 0 | 0 |
| Participant 9, Left Eye | 0 | 0 |
| Participant 10, Right Eye | -0.1 | 0.3 |
| Participant 10. Left Eye | 0.1 | 0.2 |
Median eye speed during attempted visual fixation by each eye
| Percent change | Gabapentin | Memantine |
|---|---|---|
| Participant 1, Right Eye | -59.1 | -21.5 |
| Participant 1, Left Eye | -69.8 | -35.1 |
| Participant 2, Right Eye | -19.9 | -26.0 |
| Participant 2, Left Eye | -19.8 | -35.5 |
| Participant 3, RIght Eye | -53.5 | -44.6 |
| Participant 3, Left Eye | -41.3 | -40.2 |
| Patricipant 4, RIght Eye | -72.8 | -8.6 |
| Participant 4, Left Eye | -76.6 | 11.4 |
| Participant 5, Right Eye | -56.6 | -35.5 |
| Particpant 5, Left Eye | -42.0 | -26.5 |
| Particpant 6, RIght Eye | -26.0 | -44.8 |
| Particpant 6, Left Eye | -25.9 | -29.5 |
| Particpant 7, Right Eye | 49.5 | -29.0 |
| Particpant 7, Left Eye | 26.5 | -24.1 |
| Participant 8, Right Eye | -0.9 | -60.4 |
| Participant 8, Left Eye | -0.7 | -24.8 |
| Particpant 9, Right Eye | -39.5 | 2.2 |
| Participant 9, Left Eye | -44.1 | -19.4 |
| Participant 10, Right Eye | 159 | -80.6 |
| Participant 10. Left Eye | 104.4 | -79.3 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Gabapentin | — | 0/10 (0%) | 0/10 (0%) |
| Memantine | — | 0/10 (0%) | 0/10 (0%) |
| Age, Categorical(Participants) | All Study Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 10 |
| >=65 years | 0 |
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 43.5 ± 14.9 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 7 |
| Male | 3 |
| Region of Enrollment(participants) | All Study Participants |
|---|---|
| United States | 10 |
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Gabapentin · Memantine
Case Western Reserve University →