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

NCT ID: NCT01744444

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-07-31

Brief 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. 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.

Conditions

Pendular Nystagmus Patients With Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Memantine first

Group Type: EXPERIMENTAL

Memantine

Intervention Type: 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 first

Group Type: EXPERIMENTAL

Gabapentin

Intervention Type: 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.

Interventions

Memantine

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.

Intervention Type: DRUG

Gabapentin

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caroline Tilikete, Pr

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Hôpital Neurologique Unité de Neuro-Ophtalmologie

Bron, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 31169568 (View on PubMed)

Other Identifiers

2012.737

Identifier Type: -

Identifier Source: org_study_id