The pharmacological treatment of nystagmus
Not Applicable
Completed
- Conditions
- ystagmusEye DiseasesNystagmus
- Registration Number
- ISRCTN58592532
- Lead Sponsor
- niversity Hospitals of Leicester (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 180
Inclusion Criteria
1. Patients with congenital or acquired nystagmus
2. Over the age of 16 years
Exclusion Criteria
1. Contraindication for gabapentin or memantine such as epilepsy, renal impairment, pregnancy or breast-feeding
2. For women of childbearing potential, a pregnancy test will be performed and documentation of adequate contraception during the study drug administration will be obtained
3. Patients on medication incompatible with gabapentin or memantine, such as amantadin
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in distance in Logarithm of the Minimum Angle of Resolution (LogMAR) visual acuity between memantine, gabapentin and placebo.<br><br>Each of the primary and secondary outcomes will be measured at day 0, 15, 57, 77 and 119 of each treatment arm.
- Secondary Outcome Measures
Name Time Method 1. Change in near LogMAR visual acuity between memantine, gabapentin and placebo<br>2. Change in nystagmus intensity (expanded Nystagmus Acuity Function [NAFX]) function and reading speed will be evaluated as described above at 1.2 m for the different fixation points tested and at near for null point between memantine and gabapentin and placebo<br>3. Subjective changes in visual function by self-assessment on Visual Function 14 (VF14) questionnaire between memantine and gabapentin and placebo<br><br>Each of the primary and secondary outcomes will be measured at day 0, 15, 57, 77 and 119 of each treatment arm.