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
Scientific
Neurology (127W)
Louis Stokes Department
Veterans Affairs Medical Center
10701 East Boulevard
Cleveland, Ohio
44106-1702
United States of America
| rjl4@case.edu |
Study information
| Study design | Double-blind cross-over study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please contact rjl4@case.edu to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Gabapentin, memantine |
| Primary outcome measure | 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 study start date | 22/06/2004 |
| Completion date | 22/06/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
44106-1702
United States of America
Sponsor information
National Eye Institute/National Institutes of Health (USA)
Government
Government
2020 Vision Place
Bethesda
MD 20892-3655
United States of America
| Phone | +1 301 496 5248 |
|---|---|
| 2020@nei.nih.gov | |
| Website | http://www.nei.nih.gov/ |
"ROR" |
https://ror.org/03wkg3b53 |
Funders
Funder type
Government
National Institutes of Health (NIH) (USA) (ref: R01-EY06717)
Government organisation / National government
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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.
