Nystagmus, Acquired, Nystagmus, Congenital Idiopathic
Conditions
Brief summary
The purpose of this study is to investigate the safety and efficacy of neramexane mesylate in the treatment of congenital idiopathic nystagmus (CIN) in comparison to placebo. In addition, a subgroup of multiple sclerosis (MS) patients suffering from acquired nystagmus will be included; this subgroup will be analyzed in an exploratory manner only.
Interventions
2 double-blind, cross-over treatment periods of 7 weeks separated by a wash-out phase, up to 75 mg Neramexane mesylate per day
Sponsors
Merz Pharmaceuticals GmbH
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* patients with congenital idiopathic nystagmus or acquired nystagmus subsequent to multiple sclerosis * male or female outpatients * aged between 18 and 80 years (inclusive) at screening
Exclusion criteria
* patients with evidence of neurologic disorders other than CIN such as congenital nystagmus due to albinism or retinal diseases and/or acquired nystagmus (exemption: secondary to MS)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual acuity | Screening, Baseline, Week 3, 7, 11, 14, 18, and Follow-up |
Secondary
| Measure | Time frame |
|---|---|
| nystagmus intensity, expanded nystagmus acuity function, reading ability, questionnaires, safety parameter | — |
Countries
United Kingdom
Outcome results
None listed