Efficacy and Safety Study of Neramexane to Treat Congenital and Acquired Nystagmus

Merz Pharmaceuticals GmbH48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Nystagmus, Congenital Idiopathic Nystagmus, Acquired

Interventions

Neramexane mesylateDRUG

2 double-blind, cross-over treatment periods of 7 weeks separated by a wash-out phase, up to 75 mg Neramexane mesylate per day

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)

Locations (1)

University of Leicester, Leicester Royal Infirmary, Ophthalmology Group

Leicester, United Kingdom

Outcomes

Primary Outcomes

Visual acuity

Time frame: Screening, Baseline, Week 3, 7, 11, 14, 18, and Follow-up

Secondary Outcomes

nystagmus intensity, expanded nystagmus acuity function, reading ability, questionnaires, safety parameter

Data from ClinicalTrials.gov

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