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| ID | Type | Description | Link |
|---|---|---|---|
| NIHR01EY06717 | Other Identifier | National Eye Institute | |
| NIH R01 EYO6717 | Other Grant/Funding Number | National Eye Institute |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gabapentin | Active Comparator | Increasing dose to 300 mg four times per day (total of 1200 mg/day) |
|
| Memantine | Active Comparator | Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gabapentin | Drug | increasing to 1200 mg/day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in logMAR Visual Acuity of Each Eye, Measured During Far or Near Viewing | After 2 weeks of therapy, for both drugs | |
| Percent Change in Median Eye Speed | Median eye speed during attempted visual fixation by each eye | After 2 weeks of therapy, for both drugs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard J Leigh, MD | Case Western Reserve University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veterans Affairs Medical Center, 10701 East Boulevard | Cleveland | Ohio | 44106 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Gabapentin First and Then Memantine | Increasing dose to 300 mg four times per day (total of 1200 mg/day) for the gabapentin. Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day) for memantine. |
| FG001 | Memantine First, Then Gabapentin | Increasing dose to 300 mg four times per day (total of 1200 mg/day) for the gabapentin. Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day) for memantine. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Increasing dose to 300 mg four times per day (total of 1200 mg/day) for the gabapentin. Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day) for memantine. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in logMAR Visual Acuity of Each Eye, Measured During Far or Near Viewing | Posted | Number | logMAR | After 2 weeks of therapy, for both drugs |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gabapentin | Increasing dose to 300 mg four times per day (total of 1200 mg/day) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| R. John Leigh, M.D. | Case Western Reserve University | 216-844-3190 | rjl4@case.edu |
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| ID | Term |
|---|---|
| D009759 | Nystagmus, Pathologic |
| ID | Term |
|---|---|
| D015835 | Ocular Motility Disorders |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| D008559 | Memantine |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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| memantine | Drug | increasing to 40 mg/day |
|
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
|
|
| Primary | Percent Change in Median Eye Speed | Median eye speed during attempted visual fixation by each eye | Posted | Number | Percent change | After 2 weeks of therapy, for both drugs |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Memantine | Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day). | 0 | 10 | 0 | 10 |
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| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000547 | Amantadine |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| Participant 2, Right Eye |
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| Participant 2, Left Eye |
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| Participant 3, RIght Eye |
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| Participant 3, Left Eye |
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| Patricipant 4, RIght Eye |
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| Participant 4, Left Eye |
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| Participant 5, Right Eye |
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| Particpant 5, Left Eye |
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| Particpant 6, RIght Eye |
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| Particpant 6, Left Eye |
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| Particpant 7, Right Eye |
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| Particpant 7, Left Eye |
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| Participant 8, Right Eye |
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| Participant 8, Left Eye |
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| Particpant 9, Right Eye |
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| Participant 9, Left Eye |
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| Participant 10, Right Eye |
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| Participant 10. Left Eye |
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