Pendular Nystagmus Patients With Multiple SclerosisPhase 2NCT01744444
Treatment of Pendular Nystagmus With Gabapentin and Memantine in Patients With Multiple Sclerosis
A Phase 2 study testing Memantine and Gabapentin in people with Pendular Nystagmus Patients With Multiple Sclerosis, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pendular Nystagmus Patients With Multiple Sclerosis
- What is being tested?
- Memantine and Gabapentin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2012to Jul 2013
- Phase
- Phase 2
- 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
- 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.
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
Show all 22Show fewer
- 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
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.
- Being tested
- Memantine, Gabapentin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MemantineDrug
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.
GabapentinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Memantine first | Experimental | Not described Receives: Drug: Memantine |
| Gabapentin first | Experimental | Not described Receives: Drug: Gabapentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Velocity using eye movement recording
Measured: at Day17-21
Velocity using eye movement recording
Measured: at Day34-42
Velocity using eye movement recording
Measured: at Day64-79
Velocity using eye movement recording
Measured: at Day81-100
Secondary outcomes (3)
Functional score on questioning
Measured: at Day17-21, Day34-42, Day64-79, Day81-100
Subjective measure of oscillopsia
Measured: at Day17-21, Day34-42, Day64-79, Day81-100
Far visual acuity
Measured: at Day17-21, Day34-42, Day64-79, Day81-100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionJul 2013
- Study completionJul 2013
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 Nystagmus Patients With Multiple SclerosisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT01744444
- Sponsor's protocol ID
- 2012.737
- Status last verified
- Sep 2025
- First submitted
- 30 Nov 2012
- 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 Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01744444
- Acronym / sponsor ID
- 2012.737
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 6 Dec 2012 (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.
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.
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: Memantine |
| Gabapentin first | Experimental | Drug: Gabapentin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| 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. | Drug | Memantine first |
| 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. | Drug | Gabapentin first |
Primary outcome
Velocity using eye movement recording
Time frame: at Day17-21
Velocity using eye movement recording
Time frame: at Day34-42
Velocity using eye movement recording
Time frame: at Day64-79
Velocity using eye movement recording
Time frame: at Day81-100
3 secondary outcomes
Functional score on questioning
Time frame: at Day17-21, Day34-42, Day64-79, Day81-100
Subjective measure of oscillopsia
Time frame: at Day17-21, Day34-42, Day64-79, Day81-100
Far visual acuity
Time frame: at Day17-21, Day34-42, Day64-79, Day81-100
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 2 study testing Memantine and Gabapentin in people with Pendular Nystagmus Patients With Multiple Sclerosis, 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 8 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 using eye movement recording (time frame: at Day17-21). 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 NCT01744444, 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.