Clinical trial NCT01744444: Treatment of Pendular Nystagmus With Gabapentin and Memantine in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pendular Nystagmus Patients With Multiple Sclerosis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2012-12-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Velocity using eye movement recording
timeFrame: at Day17-21
measure: Velocity using eye movement recording
timeFrame: at Day34-42
measure: Velocity using eye movement recording
timeFrame: at Day64-79
measure: Velocity using eye movement recording
timeFrame: at Day81-100
Secondary outcomes:
measure: Functional score on questioning
timeFrame: at Day17-21, Day34-42, Day64-79, Day81-100
measure: Subjective measure of oscillopsia
timeFrame: at Day17-21, Day34-42, Day64-79, Day81-100
measure: Far visual acuity
timeFrame: at Day17-21, Day34-42, Day64-79, Day81-100
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Neurologique Unité de Neuro-Ophtalmologie
Study officials:
affiliation: Hospices Civils de Lyon
name: Caroline Tilikete, Pr
role: PRINCIPAL_INVESTIGATOR
References: