Pendular NystagmusPhase 4NCT02466191
Treatment of Pendular Nystagmus in OPT
A Phase 4 study testing Memantine and Gabapentin in people with Pendular Nystagmus and Oculopalatal Tremor, run by Hospices Civils de Lyon at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pendular Nystagmus, Oculopalatal Tremor
- What is being tested?
- Memantine and Gabapentin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2015to Jan 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Pendular Nystagmus With Gabapentin and Memantine in Patients With Oculopalatal Tremor: a Controled Open-label Study
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
- Conditions
- Pendular Nystagmus, Oculopalatal Tremor
- Being tested
- Memantine, Gabapentin
- Keywords
- nystagmus, pharmacological trial, multiple sclerosis, oscillopsia
- Medical subject headings
- Nystagmus, Pathologic, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MemantineDrug
GabapentinDrug
| Study group | Role | What they receive |
|---|---|---|
| memantine first | Experimental | 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. Receives: Drug: Memantine |
| gabapentin first | Experimental | 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. Receives: Drug: Gabapentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Velocity, amplitude and frequency of nystagmus using eye movement recording
Measured: at Day 17-21
Velocity, amplitude and frequency of nystagmus using eye movement recording
Measured: at Day 34-42
Velocity, amplitude and frequency of nystagmus using eye movement recording
Measured: at Day 64-79
Velocity, amplitude and frequency of nystagmus using eye movement recording
Measured: at Day 81-100
Secondary outcomes (12)
Functional score on questioning as measured by the 25-Item National Eye Institute Visual Function Questionnaire
Measured: at Day 17-21
Functional score on questioning as measured by the 25-Item National Eye Institute Visual Function Questionnaire
Measured: at Day 34-42
Functional score on questioning as measured by the 25-Item National Eye Institute Visual Function Questionnaire
Measured: at Day 64-79
Functional score on questioning as measured by the 25-Item National Eye Institute Visual Function Questionnaire
Measured: at Day 81-100
subjective measure of oscillopsia
Measured: at Day 17-21
subjective measure of oscillopsia
Measured: at Day 34-42
subjective measure of oscillopsia
Measured: at Day 64-79
subjective measure of oscillopsia
Measured: at Day 81-100
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.
Measured: at Day 17-21
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.
Measured: at Day 34-42
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.
Measured: at Day 64-79
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.
Measured: at Day 81-100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pendular NystagmusStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline TILIKETE, Pr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02466191
- Sponsor's protocol ID
- 69HCL14_0438
- Other IDs
- 2014-005548-17, 2014
- Status last verified
- Aug 2025
- First submitted
- 22 May 2015
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Pendular Nystagmus With Gabapentin and Memantine in Patients With Oculopalatal Tremor: a Controled Open-label Study
- ClinicalTrials.gov ID
- NCT02466191
- Acronym / sponsor ID
- 69HCL14_0438
- Conditions
- Pendular Nystagmus, Oculopalatal Tremor
- Keywords
- nystagmus, pharmacological trial, multiple sclerosis, oscillopsia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 9 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| memantine first | Experimental | Drug: MemantinePatients 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 first | Experimental | Drug: GabapentinPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (22 listed)
- Ophthalmological
- Neurological
- Suicidal behavior or risk
- Treatment
- General
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Memantine | Drug | memantine first |
| Gabapentin | Drug | gabapentin first |
Primary outcome
Velocity, amplitude and frequency of nystagmus using eye movement recording
Time frame: at Day 17-21
Velocity, amplitude and frequency of nystagmus using eye movement recording
Time frame: at Day 34-42
Velocity, amplitude and frequency of nystagmus using eye movement recording
Time frame: at Day 64-79
Velocity, amplitude and frequency of nystagmus using eye movement recording
Time frame: at Day 81-100
12 secondary outcomes
Functional score on questioning as measured by the 25-Item National Eye Institute Visual Function Questionnaire
Time frame: at Day 17-21
Functional score on questioning as measured by the 25-Item National Eye Institute Visual Function Questionnaire
Time frame: at Day 34-42
Functional score on questioning as measured by the 25-Item National Eye Institute Visual Function Questionnaire
Time frame: at Day 64-79
Functional score on questioning as measured by the 25-Item National Eye Institute Visual Function Questionnaire
Time frame: at Day 81-100
subjective measure of oscillopsia
Time frame: at Day 17-21
subjective measure of oscillopsia
Time frame: at Day 34-42
subjective measure of oscillopsia
Time frame: at Day 64-79
subjective measure of oscillopsia
Time frame: at Day 81-100
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Results publication: PubMed 31169568Nerrant 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline TILIKETE, Pr principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Memantine and Gabapentin in people with Pendular Nystagmus and Oculopalatal Tremor, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Velocity, amplitude and frequency of nystagmus using eye movement recording (time frame: at Day 17-21). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02466191, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.