Cross-over Comparison of Gabapentin and Memantine as Treatment for Acquired Nystagmus

July 28, 2016 updated by: John Leigh, Case Western Reserve University

Investigation and Treatment of Ocular Motor Disorders: Cross-over Comparison of Gabapentin and Memantine as Treatment for Nystagmus

Involuntary oscillations of the eyes (nystagmus) impairs vision so that affected patients, who have neurological disorders such as Multiple Sclerosis (MS) , cannot read or watch TV. Two medicines have been reported to suppress nystagmus and improve vision in such patients: gabapentin and memantine. The investigators set out to test which of these two drug was more effective by carrying out a double-blind cross-over study. In this way, we could determine which drug worked best in each patient.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study entails careful measurements of visual acuity and precise measurements of eye movements, using a contact lens device (magnetic search coil method). In this way, it is possible to make objective and reliable measurements of the effect of each drug, which are unbiased by the investigator or the patient.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Veterans Affairs Medical Center, 10701 East Boulevard

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult (18 years or older) males or females with acquired nystagmus that is degrading their vision

Exclusion Criteria:

  • Pregnant women
  • Individuals who cannot describe their visual symptoms, cooperate with testing, or give informed consent
  • Individuals with intolerance of gabapentin or memantine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Gabapentin
Increasing dose to 300 mg four times per day (total of 1200 mg/day)
Drug: gabapentin
increasing to 1200 mg/day
Other Names:
  • Neurontin
Active Comparator: Memantine
Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day).
Drug: memantine
increasing to 40 mg/day
Other Names:
  • Nameda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in logMAR Visual Acuity of Each Eye, Measured During Far or Near Viewing
Time Frame: After 2 weeks of therapy, for both drugs
After 2 weeks of therapy, for both drugs
Percent Change in Median Eye Speed
Time Frame: After 2 weeks of therapy, for both drugs
Median eye speed during attempted visual fixation by each eye
After 2 weeks of therapy, for both drugs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Western Reserve University

Investigators

  • Principal Investigator: Richard J Leigh, MD, Case Western Reserve University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

June 25, 2009

First Submitted That Met QC Criteria

June 25, 2009

First Posted (Estimate)

June 26, 2009

Study Record Updates

Last Update Posted (Estimate)

July 29, 2016

Last Update Submitted That Met QC Criteria

July 28, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIHR01EY06717 (Other Identifier: National Eye Institute)
  • NIH R01 EYO6717 (Other Grant/Funding Number: National Eye Institute)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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