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

Phase 2

Completed

• Conditions: Nystagmus, Congenital Idiopathic; Nystagmus, Acquired
• Interventions: Drug: Neramexane mesylate

• Registration Number: NCT00661440
• Lead Sponsor: Merz Pharmaceuticals GmbH

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-04-15
• Study First Submitted QC: 2008-04-17
• Study First Posted: 2008-04-18
• Study Start: 2008-05
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-25
• Last Update Posted: 2009-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Neramexane mesylate	-
2	Neramexane mesylate	-

Primary Outcome Measures

Name	Time	Method
Visual acuity	Screening, Baseline, Week 3, 7, 11, 14, 18, and Follow-up

Secondary Outcome Measures

Name	Time	Method
nystagmus intensity, expanded nystagmus acuity function, reading ability, questionnaires, safety parameter

Trial Locations

Locations (1)

University of Leicester, Leicester Royal Infirmary, Ophthalmology Group; 🇬🇧 Leicester, United Kingdom