Pharmacological treatment of nystagmus: A randomised double masked placebo controlled crossover study using gabapentin and memantine. - Pharmacological treatment of nystagmus 3
Phase 1
- Conditions
- ystagmus
- Registration Number
- EUCTR2007-004297-40-GB
- Lead Sponsor
- niversity Hospitals of Leicester NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 180
Inclusion Criteria
Patients with cingenital or acquired nystagmus over the age of 16 years.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Patients with contraindication for gabapentin or memantine such as epilepsy, renal impairment, pregnancy or breast-feeding. For women of childbearing potential, a pregnancy test will be performed and documentation of adequate contraception during the study drug administration will be obtained. Patients on medication incompatible with gabapentin or memantine, such as amantadin.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): Completion of all examinations in 180 patients. A clinically significant improvement in visual acuity, (approximately >1 line logMAR scale), will be the primary endpoint. Secondary endpoint is a reduction of nystagmus and subjective improvement in visual acuity.;Secondary Objective: ;Main Objective: The main objective of the trial is to compare memantine and gabapentin treatment in nystagmus and to identify specific types and congenital and acquired nystagmus that respond to treatment with memantine or gabapentin in terms of improvement in visual acuity and reduction in the amount of nystagmus.
- Secondary Outcome Measures
Name Time Method