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The pharmacological treatment of nystagmus

Not Applicable
Completed
Conditions
ystagmus
Eye Diseases
Nystagmus
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
NameTimeMethod
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
NameTimeMethod
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.
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