Cross-over comparison of gabapentin and memantine as treatment for acquired nystagmus

ISRCTN ISRCTN57618066
DOI https://doi.org/10.1186/ISRCTN57618066
Secondary identifying numbers 2003-057
Submission date
23/06/2009
Registration date
01/09/2009
Last edited
08/08/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr R John Leigh
Scientific

Neurology (127W)
Louis Stokes Department
Veterans Affairs Medical Center
10701 East Boulevard
Cleveland, Ohio
44106-1702
United States of America

Email rjl4@case.edu

Study information

Study designDouble-blind cross-over study
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please contact rjl4@case.edu to request a patient information sheet
Scientific titleComparison of gabapentin and memantine as treatment for acquired nystagmus: a double-blind cross-over study with each patient serving as their own control
Study objectivesTo compare the therapeutic effects of gabapentin versus memantine at treatment for acquired nystagmus.
Ethics approval(s)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)
Health condition(s) or problem(s) studiedNystagmus
InterventionGabapentin 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Gabapentin, memantine
Primary outcome measure1. 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 measuresThe 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 study start date22/06/2004
Completion date22/06/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants10
Total final enrolment10
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment22/06/2004
Date of final enrolment22/06/2009

Locations

Countries of recruitment

  • United States of America

Study participating centre

Neurology (127W)
Cleveland, Ohio
44106-1702
United States of America

Sponsor information

National Eye Institute/National Institutes of Health (USA)
Government

2020 Vision Place
Bethesda
MD 20892-3655
United States of America

Phone +1 301 496 5248
Email 2020@nei.nih.gov
Website http://www.nei.nih.gov/
ROR logo "ROR" https://ror.org/03wkg3b53

Funders

Funder type

Government

National Institutes of Health (NIH) (USA) (ref: R01-EY06717)
Government organisation / National government
Alternative name(s)
Institutos Nacionales de la Salud, US National Institutes of Health, NIH
Location
United States of America

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/05/2010 08/08/2019 Yes No

Editorial Notes

08/08/2019: Publication reference and total final enrolment added.