Clinical Trial: Treatment of Pendular Nystagmus in OPT

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Treatment of Pendular Nystagmus With Gabapentin and Memantine in Patients With Oculopalatal Tremor: a Controled Open-label Study

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

Detailed Summary:
Sponsor: Hospices Civils de Lyon

Current Primary Outcome:

  • Velocity, amplitude and frequency of nystagmus using eye movement recording [ Time Frame: at Day 17-21 ]
  • Velocity, amplitude and frequency of nystagmus using eye movement recording [ Time Frame: at Day 34-42 ]
  • Velocity, amplitude and frequency of nystagmus using eye movement recording [ Time Frame: at Day 64-79 ]
  • Velocity, amplitude and frequency of nystagmus using eye movement recording [ Time Frame: at Day 81-100 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Functional score on questioning as measured by the 25-Item National Eye Institute Visual Function Questionnaire [ Time Frame: at Day 17-21 ]
  • Functional score on questioning as measured by the 25-Item National Eye Institute Visual Function Questionnaire [ Time Frame: at Day 34-42 ]
  • Functional score on questioning as measured by the 25-Item National Eye Institute Visual Function Questionnaire [ Time Frame: at Day 64-79 ]
  • Functional score on questioning as measured by the 25-Item National Eye Institute Visual Function Questionnaire [ Time Frame: at Day 81-100 ]
  • subjective measure of oscillopsia [ Time Frame: at Day 17-21 ]
  • subjective measure of oscillopsia [ Time Frame: at Day 34-42 ]
  • subjective measure of oscillopsia [ Time Frame: at Day 64-79 ]
  • subjective measure of oscillopsia [ Time Frame: at Day 81-100 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]


Original Secondary Outcome: Same as current

Information By: Hospices Civils de Lyon

Dates:
Date Received: May 22, 2015
Date Started: June 2015
Date Completion:
Last Updated: May 3, 2016
Last Verified: May 2016