Treatment of Pendular Nystagmus With Gabapentin and Memantine in Patients With Multiple Sclerosis

Study Overview
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Brief Summary
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Different treatment trials have been published in acquired nystagmus in the last decade; gabapentin and memantine have been found to be efficient in treating pendular nystagmus in Multiple Sclerosis. The effects of treatments are measured on nystagmus velocity, amplitude, frequency and on visual acuity. None of the trials measured a functional visual score or oscillopsia score. The aim of our study is to evaluate the effect of gabapentin and memantine on the mean velocity, amplitude and frequency of pendular nystagmus, as well as on oscillopsia, visual acuity and vision-specific health-related quality of life score, in 10 patients with multiple sclerosis. The primary object is to find out the best variable to evaluate the efficiency of nystagmus treatment and the secondary, to compare the efficiency of both gabapentin and memantine in a common population of patients.

Conditions
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Pendular Nystagmus Patients With Multiple Sclerosis

Intervention / Treatment
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* Drug: Memantine
* Drug: Gabapentin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients may have a clinically definite, laboratory-supported diagnosis of multiple sclerosis according to the Mac Donald criteria. All patients may present a chronic acquired pendular nystagmus due to MS, observed over a period of 6 months. All patients will be informed about the design and purpose of the study, and all will give their informed, written consent to the protocol, which may have been approved by the local ethics committee. Age: above 18 Able to understand the instructions Having a health coverage Able to sit down for 1 hour Stable dosage of previous medications (beginning 3 weeks previously and terminating at the end of the trial duration), except for steroids, gabapentin or memantine. Exclusion Criteria: Ophthalmological Other ophthalmological disorder that could impair corrected visual acuity (Maculopathy, Retinopathy…) Neurological Ongoing seizure Severe handicap that does not allow sitting down position for 1 hour Suicidal behavior or risk Treatment Under memantine or gabapentin medication (these medications should have been stopped for at least 1 week for gabapentin and 3 weeks for memantine) Under morphine, N-methyl-D-aspartate such as amantadine, ketamine or dextromethorphan Steroid medication for a current relapse (beginning 3 weeks previously and terminating at the end of the trial duration) Known hypersensitivity to memantine or gabapentin General Unstable medical state Patient with a galactose intolerance, a lapp lactase deficiency or glucose-galactose malabsorption Moderate renal failure (creatinine clearance < 50 mL/min on bioassay dated from less than one month) Recent heart infarction (<3months) Unstable congestive heart insufficiency Unstable arterial hypertension Leucopenia (<2500/mm3) Transaminase increase (>5 time normal values) Pregnancy (on questioning) Tutelage or any legal protection measure

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Memantine first<br> | Drug: Memantine<br>* Patients will be randomly assigned to start on either memantine or gabapentin. For tolerance reasons, each treatment begins with a progressive increasing dose and stops with a progressive decreasing dose. The duration of the period of last dose (8 to 11 days) will be chosen according to the investigator's availability to organize post-tests.<br>|
| Experimental: Gabapentin first<br> | Drug: Gabapentin<br>* Patients will be randomly assigned to start on either memantine or gabapentin. For tolerance reasons, each treatment begins with a progressive increasing dose and stops with a progressive decreasing dose. The duration of the period of last dose (8 to 11 days) will be chosen according to the investigator's availability to organize post-tests.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Velocity using eye movement recording |  | at Day17-21 | 
| Velocity using eye movement recording |  | at Day34-42 | 
| Velocity using eye movement recording |  | at Day64-79 | 
| Velocity using eye movement recording |  | at Day81-100 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional score on questioning |  | at Day17-21, Day34-42, Day64-79, Day81-100 | 
| Subjective measure of oscillopsia |  | at Day17-21, Day34-42, Day64-79, Day81-100 | 
| Far visual acuity |  | at Day17-21, Day34-42, Day64-79, Day81-100 |