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

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 Overview

• Status: Completed
• Conditions: Pendular Nystagmus Patients With Multiple Sclerosis
• Intervention / Treatment: Drug: Memantine; Drug: Gabapentin

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Bron, France, 69677
    • Hôpital Neurologique Unité de Neuro-Ophtalmologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Memantine first	Drug: 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.
Experimental: Gabapentin first	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Caroline Tilikete, Pr, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: November 30, 2012
• First Submitted That Met QC Criteria: December 5, 2012
• First Posted (Estimate): December 6, 2012

Study Record Updates

• Last Update Posted (Estimate): December 18, 2013
• Last Update Submitted That Met QC Criteria: December 17, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Eye Diseases; Cranial Nerve Diseases; Ocular Motility Disorders; Multiple Sclerosis; Sclerosis; Nystagmus, Pathologic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Dopamine Agents; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Gabapentin; Memantine
• Other Study ID Numbers: 2012.737