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Completed

NCT Number: NCT02466191

Treatment of Pendular Nystagmus in OPT

Pendular nystagmus corresponds to an enduring to and fro eye oscillation without resetting quick phases. The most common causes of acquired pendular nystagmus (APN) are multiple sclerosis (MS) and focal brainstem lesions (oculopalatal tremor, OPT). Based on pathophysiological hypothesis, pharmacological treatments of acquired nystagmus have been thoroughly proposed over different publications of cases, series, reviews or expert opinions. Acquired pendular nystagmus underwent the most rigorous treatment trials, leading to the proposal of gabapentin or memantine as valuable drugs. Whether gabapentin and memantine are effective in APN associated with OPT remains unclear, since none of the previous studies has evaluated the effect of these medications in a group of OPT patients. However, this is an important issue in prospect to a clinical use of these medications. In the current study, the investigators aim is to evaluate the effect of gabapentin and memantine on the mean velocity, amplitude and frequency of pendular nystagmus, as well as on visual acuity and vision-specific health-related quality of life score, in a group of OPT patients

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Key information

Conditions

Pendular Nystagmus Autoimmune Diseases Autoimmune Diseases of the Nervous System Cranial Nerve Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Eye Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases Nystagmus, Pathologic Ocular Motility Disorders Oculopalatal Tremor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospices Civils de Lyon

Lyon, 69002, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with a diagnosis of oculopalatal tremor (OPT), following a focal brainstem lesion.
  • All patients may present a chronic acquired pendular nystagmus due to OPT, 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 gabapentin or memantine.
  • For women: efficient contraception during the experimental time and in the two month following treatment withdrawal.

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

Gabapentin

Drug

Primary outcomes

  1. Velocity, amplitude and frequency of nystagmus using eye movement recording

    Time frame: at Day 17-21

  2. Velocity, amplitude and frequency of nystagmus using eye movement recording

    Time frame: at Day 34-42

  3. Velocity, amplitude and frequency of nystagmus using eye movement recording

    Time frame: at Day 64-79

  4. Velocity, amplitude and frequency of nystagmus using eye movement recording

    Time frame: at Day 81-100

Secondary outcomes

  1. Functional score on questioning as measured by the 25-Item National Eye Institute Visual Function Questionnaire

    Time frame: at Day 17-21

  2. Functional score on questioning as measured by the 25-Item National Eye Institute Visual Function Questionnaire

    Time frame: at Day 34-42

  3. Functional score on questioning as measured by the 25-Item National Eye Institute Visual Function Questionnaire

    Time frame: at Day 64-79

  4. Functional score on questioning as measured by the 25-Item National Eye Institute Visual Function Questionnaire

    Time frame: at Day 81-100

  5. subjective measure of oscillopsia

    Time frame: at Day 17-21

  6. subjective measure of oscillopsia

    Time frame: at Day 34-42

  7. subjective measure of oscillopsia

    Time frame: at Day 64-79

  8. subjective measure of oscillopsia

    Time frame: at Day 81-100

  9. far visual acuity as measured by monocularly and binocularly direction and amplitude (measures in degrees) of their oscillopsia while viewing, with best correction, a stationary target at far (5 m) and near (57 cm) location.

    Time frame: at Day 17-21

  10. far visual acuity as measured by monocularly and binocularly direction and amplitude (measures in degrees) of their oscillopsia while viewing, with best correction, a stationary target at far (5 m) and near (57 cm) location.

    Time frame: at Day 34-42

  11. far visual acuity as measured by monocularly and binocularly direction and amplitude (measures in degrees) of their oscillopsia while viewing, with best correction, a stationary target at far (5 m) and near (57 cm) location.

    Time frame: at Day 64-79

  12. far visual acuity as measured by monocularly and binocularly direction and amplitude (measures in degrees) of their oscillopsia while viewing, with best correction, a stationary target at far (5 m) and near (57 cm) location.

    Time frame: at Day 81-100

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Treatment of Pendular Nystagmus With Gabapentin and Memantine in Patients With Oculopalatal Tremor: a Controled Open-label Study

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 9, 2015
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.

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