CompletedPhase 2MS (type not specified)NCT01744444

What it found

Result in a paper, not read yet

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Memantine
  • Gabapentin

    Voltage-gated calcium channel modulator

What it measured

Main measures

  • Velocity using eye movement recording

    at Day17-21

    Nerve conduction tests
  • Velocity using eye movement recording

    at Day34-42

    Nerve conduction tests
  • Velocity using eye movement recording

    at Day64-79

    Nerve conduction tests
  • Velocity using eye movement recording

    at Day81-100

    Nerve conduction tests

Other measures (3)

  • Functional score on questioning

    at Day17-21, Day34-42, Day64-79, Day81-100

  • Subjective measure of oscillopsia

    at Day17-21, Day34-42, Day64-79, Day81-100

  • Far visual acuity

    at Day17-21, Day34-42, Day64-79, Day81-100

    Vision

Who could take part

MS (type not specified) · 18 and over

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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Related trials

History

    1. Started

      Nov 2012

    2. Main results due

      Jul 2013

    3. Finished

      Jul 2013

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