|
ISRCTN
|
ISRCTN57618066
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Cross-over comparison of gabapentin and memantine as treatment for acquired nystagmus
|
|
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
|
N/A
|
|
Serial number at source
|
2003-057
|
|
Study hypothesis
|
To compare the therapeutic effects of gabapentin versus memantine at treatment for acquired nystagmus.
|
|
Lay summary
|
|
|
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
|
|
Countries of recruitment
|
United States of America
|
|
Disease/condition/study domain
|
Nystagmus
|
|
Participants - 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
|
|
Participants - 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
|
|
Anticipated start date
|
22/06/2004
|
|
Anticipated end date
|
22/06/2009
|
|
Status of trial
|
Completed |
|
Patient information material
|
Not available in web format, please contact rjl4@case.edu to request a patient information sheet
|
|
Target number of participants
|
10
|
|
Interventions
|
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.
|
|
Primary outcome measure(s)
|
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 measure(s)
|
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.
|
|
Sources of funding
|
National Institutes of Health (NIH) (USA) (ref: R01-EY06717)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
R John
Leigh
|
|
Address
|
Neurology (127W)
Louis Stokes Department
Veterans Affairs Medical Center
10701 East Boulevard
|
|
City/town
|
Cleveland, Ohio
|
|
Zip/Postcode
|
44106-1702
|
|
Country
|
United States of America
|
|
Email
|
rjl4@case.edu
|
|
Sponsor
|
National Eye Institute/National Institutes of Health (USA)
|
|
Address
|
2020 Vision Place
|
|
City/town
|
Bethesda
|
|
Zip/Postcode
|
MD 20892-3655
|
|
Country
|
United States of America
|
|
Tel
|
+1 301 496 5248
|
|
Email
|
2020@nei.nih.gov
|
|
Sponsor website:
|
http://www.nei.nih.gov/
|
|
Date applied
|
23/06/2009
|
|
Last edited
|
01/09/2009
|
|
Date ISRCTN assigned
|
01/09/2009
|
