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

ISRCTN	ISRCTN57618066
DOI	https://doi.org/10.1186/ISRCTN57618066
Protocol serial number	2003-057
Sponsor	National Eye Institute/National Institutes of Health (USA)
Funder	National Institutes of Health (NIH) (USA) (ref: R01-EY06717)

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

Primary study design	Interventional
Study design	Double-blind cross-over study
Secondary study design	Non randomised controlled trial
Study type	Participant information sheet
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
Study objectives	To 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) studied	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 / device / biological / vaccine name(s)	Gabapentin, memantine
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.
Key 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.
Completion date	22/06/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	10
Total final enrolment	10
Key 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
Key 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
Date of first enrolment	22/06/2004
Date of final enrolment	22/06/2009

Locations

Countries of recruitment

United States of America

Study participating centre

Neurology (127W)

Cleveland, Ohio
44106-1702
United States of America

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

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