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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00928954
Recruitment Status : Completed
First Posted : June 26, 2009
Results First Posted : July 29, 2016
Last Update Posted : July 29, 2016
Information provided by (Responsible Party):
John Leigh, Case Western Reserve University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Nystagmus Drug: gabapentin Drug: memantine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigation and Treatment of Ocular Motor Disorders: Cross-over Comparison of Gabapentin and Memantine as Treatment for Nystagmus
Study Start Date : February 2005
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

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 Name: 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 Name: Nameda

Primary Outcome Measures :
  1. Change in logMAR Visual Acuity of Each Eye, Measured During Far or Near Viewing [ Time Frame: After 2 weeks of therapy, for both drugs ]
  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00928954

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United States, Ohio
Veterans Affairs Medical Center, 10701 East Boulevard
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Case Western Reserve University
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Principal Investigator: Richard J Leigh, MD Case Western Reserve University
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Responsible Party: John Leigh, R. John Leigh, M.D., Case Western Reserve University Identifier: NCT00928954    
Other Study ID Numbers: NIHR01EY06717
NIHR01EY06717 ( Other Identifier: National Eye Institute )
NIH R01 EYO6717 ( Other Grant/Funding Number: National Eye Institute )
First Posted: June 26, 2009    Key Record Dates
Results First Posted: July 29, 2016
Last Update Posted: July 29, 2016
Last Verified: July 2016
Keywords provided by John Leigh, Case Western Reserve University:
Drug treatment
Additional relevant MeSH terms:
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Nystagmus, Pathologic
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents