search
Back to results

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

Primary Purpose

Pendular Nystagmus Patients With Multiple Sclerosis

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Memantine
Gabapentin
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pendular Nystagmus Patients With Multiple Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Neurologique Unité de Neuro-Ophtalmologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Memantine first

Gabapentin first

Arm Description

Outcomes

Primary Outcome Measures

Velocity using eye movement recording
Velocity using eye movement recording
Velocity using eye movement recording
Velocity using eye movement recording

Secondary Outcome Measures

Functional score on questioning
Subjective measure of oscillopsia
Far visual acuity

Full Information

First Posted
November 30, 2012
Last Updated
December 17, 2013
Sponsor
Hospices Civils de Lyon
search

1. Study Identification

Unique Protocol Identification Number
NCT01744444
Brief Title
Treatment of Pendular Nystagmus With Gabapentin and Memantine in Patients With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pendular Nystagmus Patients With Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Memantine first
Arm Type
Experimental
Arm Title
Gabapentin first
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Memantine
Intervention Description
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
Intervention Name(s)
Gabapentin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Velocity using eye movement recording
Time Frame
at Day17-21
Title
Velocity using eye movement recording
Time Frame
at Day34-42
Title
Velocity using eye movement recording
Time Frame
at Day64-79
Title
Velocity using eye movement recording
Time Frame
at Day81-100
Secondary Outcome Measure Information:
Title
Functional score on questioning
Time Frame
at Day17-21, Day34-42, Day64-79, Day81-100
Title
Subjective measure of oscillopsia
Time Frame
at Day17-21, Day34-42, Day64-79, Day81-100
Title
Far visual acuity
Time Frame
at Day17-21, Day34-42, Day64-79, Day81-100

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline Tilikete, Pr
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Neurologique Unité de Neuro-Ophtalmologie
City
Bron
ZIP/Postal Code
69677
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs