Contact information
Type
Scientific
Primary contact
Dr R John Leigh
ORCID ID
Contact details
Neurology (127W)
Louis Stokes Department
Veterans Affairs Medical Center
10701 East Boulevard
Cleveland
Ohio
44106-1702
United States of America
rjl4@case.edu
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2003-057
Study information
Scientific title
Comparison of gabapentin and memantine as treatment for acquired nystagmus: a double-blind cross-over study with each patient serving as their own control
Acronym
Study hypothesis
To compare the therapeutic effects of gabapentin versus memantine at treatment for acquired nystagmus.
Ethics approval
1. Cleveland Veterans Affairs Medical Center Institutional Review Board approved on the 22nd June 2004
2. US Food and Drug Adminstration approved on the 8th January 2004 (ref: CPA #521)
Study design
Double-blind cross-over study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please contact rjl4@case.edu to request a patient information sheet
Condition
Nystagmus
Intervention
Gabapentin will be given at a starting dose of 1 capsule (300 mg) per day for 3 days; then 1 capsule twice per day for 3 days; then 1 capsule three times per day for 3 days, and finally 1 capsule four times per day (total = 1200 mg/day) for the final remaining 5 days. The final evaluation of vision and eye movements will be made during the 14th day of taking gabapentin. Memantine will be given at a starting dose of 1 capsule (10 mg) per day for 3 days; then 1 capsule twice per day for 3 days; then 1 capsule three times per day for 3 days, and finally 1 capsule four times per day (total = 40 mg/day) for the final remaining 5 days. The final evaluation of vision and eye movements will be made during the 14th day of taking memantine. Side effects of each medication will be monitored with a provision for holding at the maximum dose of the drug that the patient can tolerate for the duration of the study.
Intervention type
Drug
Phase
Not Applicable
Drug names
Gabapentin, memantine
Primary outcome measures
1. Visual acuity of each eye, measured at far or near prior to, and on the final day of, treatment with each drug
2. Median eye speed, measured with the magnetic search coil technique, prior to, and on the final day of, treatment with each drug
Measured at the end of 14 days on each medicine.
Secondary outcome measures
The patient's overall assessment of whether either drug improves their vision and is generally well tolerated, measured at the end of 14 days on each medicine.
Overall trial start date
22/06/2004
Overall trial end date
22/06/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients with acquired nystagmus due to multiple sclerosis, stroke (brain stem) or cerebellar disease (such as Chiari malformation)
2. Medically stable
3. Able to give informed consent
4. Can understand and cooperate with the testing
5. Aged 18 years or older, both sexes
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
10
Participant exclusion criteria
1. Not able to understand or follow the instructions of each protocol
2. Too frail to sit in the vestibular chair during testing for the required period
3. Judged to be at risk for falls (many patients with poor balance adjust to this, and are not at risk of falls)
4. History of mental illness or confusion
5. Known to have an allergy to gabapentin or memantine
6. Pregnant, since the safety of memantine in pregnancy is unknown
Recruitment start date
22/06/2004
Recruitment end date
22/06/2009
Locations
Countries of recruitment
United States of America
Trial participating centre
Neurology (127W)
Cleveland, Ohio
44106-1702
United States of America
Sponsor information
Organisation
National Eye Institute/National Institutes of Health (USA)
Sponsor details
2020 Vision Place
Bethesda
MD 20892-3655
United States of America
+1 301 496 5248
2020@nei.nih.gov
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
National Institutes of Health (NIH) (USA) (ref: R01-EY06717)
Alternative name(s)
NIH
Funding Body Type
government organisation
Funding Body Subtype
federal/national government
Location
United States of America
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary