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OpenTrials
Completed

NCT Number: NCT01744444

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

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.

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Key information

Conditions

Pendular Nystagmus Patients With Multiple Sclerosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hôpital Neurologique Unité de Neuro-Ophtalmologie

Bron, 69677, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Memantine

Drug

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.

Gabapentin

Drug

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.

Primary outcomes

  1. Velocity using eye movement recording

    Time frame: at Day17-21

  2. Velocity using eye movement recording

    Time frame: at Day34-42

  3. Velocity using eye movement recording

    Time frame: at Day64-79

  4. Velocity using eye movement recording

    Time frame: at Day81-100

Secondary outcomes

  1. Functional score on questioning

    Time frame: at Day17-21, Day34-42, Day64-79, Day81-100

  2. Subjective measure of oscillopsia

    Time frame: at Day17-21, Day34-42, Day64-79, Day81-100

  3. Far visual acuity

    Time frame: at Day17-21, Day34-42, Day64-79, Day81-100

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 6, 2012
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.