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

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ClinicalTrials.gov Identifier: NCT01744444
Recruitment Status : Completed
First Posted : December 6, 2012
Last Update Posted : December 18, 2013
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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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.


Condition or disease Intervention/treatment Phase
Pendular Nystagmus Patients With Multiple Sclerosis Drug: Memantine Drug: Gabapentin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Velocity using eye movement recording [ Time Frame: at Day17-21 ]
  2. Velocity using eye movement recording [ Time Frame: at Day34-42 ]
  3. Velocity using eye movement recording [ Time Frame: at Day64-79 ]
  4. Velocity using eye movement recording [ Time Frame: at Day81-100 ]

Secondary Outcome Measures :
  1. Functional score on questioning [ Time Frame: at Day17-21, Day34-42, Day64-79, Day81-100 ]
  2. Subjective measure of oscillopsia [ Time Frame: at Day17-21, Day34-42, Day64-79, Day81-100 ]
  3. Far visual acuity [ Time Frame: at Day17-21, Day34-42, Day64-79, Day81-100 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01744444


Locations
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France
Hôpital Neurologique Unité de Neuro-Ophtalmologie
Bron, France, 69677
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Caroline Tilikete, Pr Hospices Civils de Lyon
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01744444    
Other Study ID Numbers: 2012.737
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: December 2013
Additional relevant MeSH terms:
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Multiple Sclerosis
Nystagmus, Pathologic
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Ocular Motility Disorders
Cranial Nerve Diseases
Eye Diseases
Gabapentin
Memantine
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Antiparkinson Agents