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

NCT01744444 | Completed Phase 2

• 1 other identifier: 2012.737
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Velocity using eye movement recording

  at Day17-21

• Velocity using eye movement recording

  at Day34-42

• Velocity using eye movement recording

  at Day64-79

• Velocity using eye movement recording

  at Day81-100

Secondary Outcomes (3)

• Functional score on questioning

  at Day17-21, Day34-42, Day64-79, Day81-100

• Subjective measure of oscillopsia

  at Day17-21, Day34-42, Day64-79, Day81-100

• Far visual acuity

  at Day17-21, Day34-42, Day64-79, Day81-100

Study Arms (2)

Memantine first

EXPERIMENTAL

Drug: Memantine

Gabapentin first

EXPERIMENTAL

Drug: Gabapentin

Interventions

Memantine 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.

Memantine first

Gabapentin 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Neurologique Unité de Neuro-Ophtalmologie

Bron, 69677, France

Location

Related Publications (1)

• 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.

  PMID: 31169568 BACKGROUND

MeSH Terms

Interventions

Memantine; Gabapentin

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Amines; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Caroline Tilikete, Pr

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2012
• First Posted: December 6, 2012
• Study Start: November 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: September 3, 2025

Record last verified: 2025-09

Locations

FR (1)