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

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ClinicalTrials.gov Identifier: NCT00928954

Recruitment Status : Completed

First Posted : June 26, 2009

Results First Posted : July 29, 2016

Last Update Posted : July 29, 2016

Sponsor:

Information provided by (Responsible Party):

John Leigh, Case Western Reserve University

Study Description

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.

Study Design

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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

Resource links provided by the National Library of Medicine

Drug Information available for: Memantine Memantine hydrochloride Gabapentin Gabapentin enacarbil

Genetic and Rare Diseases Information Center resources: Oculocerebral Syndrome With Hypopigmentation

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

Change in logMAR Visual Acuity of Each Eye, Measured During Far or Near Viewing [ Time Frame: 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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00928954

Locations

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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

Investigators

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

More Information

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Responsible Party:	John Leigh, R. John Leigh, M.D., Case Western Reserve University
ClinicalTrials.gov 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:


gabapentin memantine nystagmus Drug treatment

Additional relevant MeSH terms:

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Nystagmus, Pathologic Ocular Motility Disorders Cranial Nerve Diseases Nervous System Diseases Eye Diseases Gabapentin Memantine Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anticonvulsants	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

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