Cross-Over Comparison of Gabapentin and Memantine as Treatment for Acquired Nystagmus | RxWiki

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

Overview[ - collapse ][ - ]

Purpose	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	Nystagmus, Pathological
Intervention	Drug: gabapentin Drug: memantine
Phase	N/A
Sponsor	Case Western Reserve University
Responsible Party	Case Western Reserve University
ClinicalTrials.gov Identifier	NCT00928954
First Received	June 25, 2009
Last Updated	June 25, 2009
Last verified	June 2009

Tracking Information[ + expand ][ + ]

First Received Date	June 25, 2009
Last Updated Date	June 25, 2009
Start Date	February 2005
Estimated Primary Completion Date	May 2009
Current Primary Outcome Measures	Visual acuity of each eye, measured during far or near viewing [Time Frame: After 2 weeks of therapy, for both drugs] [Designated as safety issue: No] Median eye speed during attempted visual fixation, of each eye. [Time Frame: Measured after two weeks of therapy with either drug] [Designated as safety issue: No]
Current Secondary Outcome Measures	Patient's report of whether they think that they have benefitted from either drug treatment [Time Frame: After two weeks of therapy, for either drug] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	Cross-Over Comparison of Gabapentin and Memantine as Treatment for Acquired Nystagmus
Official Title	Investigation and Treatment of Ocular Motor Disorders: Cross-Over Comparison of Gabapentin and Memantine as Treatment for Nystagmus
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.
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
Study Phase	N/A
Study Design	Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Condition	Nystagmus, Pathological
Intervention	Drug: gabapentin increasing to 1200 mg/day Other Names: NeurontinDrug: memantine increasing to 40 mg/day Other Names: Nameda
Study Arm (s)	Active Comparator: Gabapentin Increasing dose to 300 mg four times per day (total of 1200 mg/day) Active Comparator: Memantine Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day).

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	10
Estimated Completion Date	May 2009
Estimated Primary Completion Date	May 2009
Eligibility 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 described their visual symptoms, cooperate with testing, or give informed consent - Individuals with intolerance of gabapentin or memantine
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00928954
Other Study ID Numbers	NIHR01EY06717
Has Data Monitoring Committee	Yes
Information Provided By	Case Western Reserve University
Study Sponsor	Case Western Reserve University
Collaborators	Not Provided
Investigators	Not Provided
Verification Date	June 2009

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