ClinicalTrials.gg
CompletedNCT02466191Updated Sep 3, 2025

Treatment of Pendular Nystagmus in OPT

A Phase 4 interventional study of Memantine and Gabapentin in Pendular Nystagmus and Oculopalatal Tremor, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-03.

Sponsored by Hospices Civils de Lyon · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
7
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Pendular Nystagmus
  • Oculopalatal Tremor

Keywords

  • nystagmus
  • pharmacological trial
  • multiple sclerosis
  • oscillopsia
03

In context

Nystagmus, Pathologic

27 studies on the registry are indexed under Nystagmus, Pathologic; 3 are open to participants now.

This study's enrollment of 7 is below the median of 48 across 17 interventional studies indexed under Nystagmus, Pathologic.

Browse Nystagmus, Pathologic studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 during the experimental time and in the two month following treatment withdrawal.

Exclusion criteria

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
    • medication for a current relapse (beginning 3 weeks previously and terminating at the end of the trial duration
    • Known to memantine or gabapentin
  • General

    • Unstable medical state
    • Patient with a galactose intolerance, a lapp lactase deficiency or glucose-galactose malabsorption
    • Moderate renal failure ( \< 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
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    memantine first

    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.

    Drug: Memantine

  • Experimental
    gabapentin first

    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.

    Drug: Gabapentin

Interventions

06

What researchers measure

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

07

Study locations

1 site
  • Hospices Civils de Lyon
    Lyon, 69002, France
08

References and documents

Publications

  • Nerrant E, Abouaf L, Pollet-Villard F, Vie AL, Vukusic S, Berthiller J, Colombet B, Vighetto A, Tilikete C. Gabapentin and Memantine for Treatment of Acquired Pendular Nystagmus: Effects on Visual Outcomes. J Neuroophthalmol. 2020 Jun;40(2):198-206. doi: 10.1097/WNO.0000000000000807. PubMed 31169568 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02466191
Responsible party
Sponsor
First posted
Jun 9, 2015
Start date
Jun 2015
Primary completion
Jan 2016
Completion
Jan 2016
Last update
Sep 3, 2025

Study contacts

Caroline TILIKETE, Pr
principal investigator · Hospices Civils de Lyon

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Memantine · Gabapentin

Start the discussion