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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01744444
First received: November 30, 2012
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Pendular Nystagmus Patients With Multiple Sclerosis
Drug: Memantine
Drug: Gabapentin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Velocity using eye movement recording [ Time Frame: at Day17-21 ] [ Designated as safety issue: No ]
  • Velocity using eye movement recording [ Time Frame: at Day34-42 ] [ Designated as safety issue: No ]
  • Velocity using eye movement recording [ Time Frame: at Day64-79 ] [ Designated as safety issue: No ]
  • Velocity using eye movement recording [ Time Frame: at Day81-100 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional score on questioning [ Time Frame: at Day17-21, Day34-42, Day64-79, Day81-100 ] [ Designated as safety issue: No ]
  • Subjective measure of oscillopsia [ Time Frame: at Day17-21, Day34-42, Day64-79, Day81-100 ] [ Designated as safety issue: No ]
  • Far visual acuity [ Time Frame: at Day17-21, Day34-42, Day64-79, Day81-100 ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: November 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01744444

Locations
France
Hôpital Neurologique Unité de Neuro-Ophtalmologie
Bron, France, 69677
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Caroline Tilikete, Pr Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01744444     History of Changes
Other Study ID Numbers: 2012.737
Study First Received: November 30, 2012
Last Updated: December 17, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Multiple Sclerosis
Nystagmus, Pathologic
Sclerosis
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
Pathologic Processes
Memantine
Gabapentin
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on July 29, 2014