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Treatment of Pendular Nystagmus in OPT

Primary Purpose

Pendular Nystagmus, Oculopalatal Tremor

Status
Completed
Phase
Phase 4
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 focused on measuring nystagmus, pharmacological trial, multiple sclerosis, oscillopsia

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with a diagnosis of oculopalatal tremor (OPT), following a focal brainstem lesion.
  • All patients may present a chronic acquired pendular nystagmus due to OPT, 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 gabapentin or memantine.
  • For women: efficient contraception during the experimental time and in the two month following treatment withdrawal.

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

  • Hospices Civils de Lyon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

memantine first

gabapentin first

Arm 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.

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.

Outcomes

Primary Outcome Measures

Velocity, amplitude and frequency of nystagmus using eye movement recording
Velocity, amplitude and frequency of nystagmus using eye movement recording
Velocity, amplitude and frequency of nystagmus using eye movement recording
Velocity, amplitude and frequency of nystagmus using eye movement recording

Secondary Outcome Measures

Functional score on questioning as measured by the 25-Item National Eye Institute Visual Function Questionnaire
Functional score on questioning as measured by the 25-Item National Eye Institute Visual Function Questionnaire
Functional score on questioning as measured by the 25-Item National Eye Institute Visual Function Questionnaire
Functional score on questioning as measured by the 25-Item National Eye Institute Visual Function Questionnaire
subjective measure of oscillopsia
subjective measure of oscillopsia
subjective measure of oscillopsia
subjective measure of oscillopsia
far visual acuity as measured by monocularly and binocularly direction and amplitude (measures in degrees) of their oscillopsia while viewing, with best correction, a stationary target at far (5 m) and near (57 cm) location.
far visual acuity as measured by monocularly and binocularly direction and amplitude (measures in degrees) of their oscillopsia while viewing, with best correction, a stationary target at far (5 m) and near (57 cm) location.
far visual acuity as measured by monocularly and binocularly direction and amplitude (measures in degrees) of their oscillopsia while viewing, with best correction, a stationary target at far (5 m) and near (57 cm) location.
far visual acuity as measured by monocularly and binocularly direction and amplitude (measures in degrees) of their oscillopsia while viewing, with best correction, a stationary target at far (5 m) and near (57 cm) location.

Full Information

First Posted
May 22, 2015
Last Updated
July 10, 2018
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02466191
Brief Title
Treatment of Pendular Nystagmus in OPT
Official Title
Treatment of Pendular Nystagmus With Gabapentin and Memantine in Patients With Oculopalatal Tremor: a Controled Open-label Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (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
Pendular nystagmus corresponds to an enduring to and fro eye oscillation without resetting quick phases. The most common causes of acquired pendular nystagmus (APN) are multiple sclerosis (MS) and focal brainstem lesions (oculopalatal tremor, OPT). Based on pathophysiological hypothesis, pharmacological treatments of acquired nystagmus have been thoroughly proposed over different publications of cases, series, reviews or expert opinions. Acquired pendular nystagmus underwent the most rigorous treatment trials, leading to the proposal of gabapentin or memantine as valuable drugs. Whether gabapentin and memantine are effective in APN associated with OPT remains unclear, since none of the previous studies has evaluated the effect of these medications in a group of OPT patients. However, this is an important issue in prospect to a clinical use of these medications. In the current study, the investigators aim is to evaluate the effect of gabapentin and memantine on the mean velocity, amplitude and frequency of pendular nystagmus, as well as on visual acuity and vision-specific health-related quality of life score, in a group of OPT patients

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pendular Nystagmus, Oculopalatal Tremor
Keywords
nystagmus, pharmacological trial, multiple sclerosis, oscillopsia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
memantine first
Arm Type
Experimental
Arm 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.
Arm Title
gabapentin first
Arm Type
Experimental
Arm 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)
Memantine
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Primary Outcome Measure Information:
Title
Velocity, amplitude and frequency of nystagmus using eye movement recording
Time Frame
at Day 17-21
Title
Velocity, amplitude and frequency of nystagmus using eye movement recording
Time Frame
at Day 34-42
Title
Velocity, amplitude and frequency of nystagmus using eye movement recording
Time Frame
at Day 64-79
Title
Velocity, amplitude and frequency of nystagmus using eye movement recording
Time Frame
at Day 81-100
Secondary Outcome Measure Information:
Title
Functional score on questioning as measured by the 25-Item National Eye Institute Visual Function Questionnaire
Time Frame
at Day 17-21
Title
Functional score on questioning as measured by the 25-Item National Eye Institute Visual Function Questionnaire
Time Frame
at Day 34-42
Title
Functional score on questioning as measured by the 25-Item National Eye Institute Visual Function Questionnaire
Time Frame
at Day 64-79
Title
Functional score on questioning as measured by the 25-Item National Eye Institute Visual Function Questionnaire
Time Frame
at Day 81-100
Title
subjective measure of oscillopsia
Time Frame
at Day 17-21
Title
subjective measure of oscillopsia
Time Frame
at Day 34-42
Title
subjective measure of oscillopsia
Time Frame
at Day 64-79
Title
subjective measure of oscillopsia
Time Frame
at Day 81-100
Title
far visual acuity as measured by monocularly and binocularly direction and amplitude (measures in degrees) of their oscillopsia while viewing, with best correction, a stationary target at far (5 m) and near (57 cm) location.
Time Frame
at Day 17-21
Title
far visual acuity as measured by monocularly and binocularly direction and amplitude (measures in degrees) of their oscillopsia while viewing, with best correction, a stationary target at far (5 m) and near (57 cm) location.
Time Frame
at Day 34-42
Title
far visual acuity as measured by monocularly and binocularly direction and amplitude (measures in degrees) of their oscillopsia while viewing, with best correction, a stationary target at far (5 m) and near (57 cm) location.
Time Frame
at Day 64-79
Title
far visual acuity as measured by monocularly and binocularly direction and amplitude (measures in degrees) of their oscillopsia while viewing, with best correction, a stationary target at far (5 m) and near (57 cm) location.
Time Frame
at Day 81-100

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with a diagnosis of oculopalatal tremor (OPT), following a focal brainstem lesion. All patients may present a chronic acquired pendular nystagmus due to OPT, 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 gabapentin or memantine. For women: efficient contraception during the experimental time and in the two month following treatment withdrawal. 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
Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69002
Country
France

12. IPD Sharing Statement

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Treatment of Pendular Nystagmus in OPT

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