Condition category
Eye Diseases
Date applied
23/06/2009
Date assigned
01/09/2009
Last edited
01/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.nei.nih.gov/

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

Publication citations

Additional files

Editorial Notes