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

Efficacy and Safety of Neramexane Mesylate in Congenital Idiopathic Nystagmus and Acquired Nystagmus: a Randomized, Double-blind, Placebo-controlled, Single Center, Proof of Concept Study Using a Two-period Cross-over Design

Sponsors

Lead Sponsor: Merz Pharmaceuticals GmbH

Source 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.

Overall Status Completed
Start Date 2008-05-01
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Visual acuity Screening, Baseline, Week 3, 7, 11, 14, 18, and Follow-up
Secondary Outcome
Measure Time Frame
nystagmus intensity, expanded nystagmus acuity function, reading ability, questionnaires, safety parameter
Enrollment 48
Condition
Intervention

Intervention Type: Drug

Intervention Name: Neramexane mesylate

Description: 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

Criteria:

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)

Gender:

All

Minimum Age:

18 Years

Maximum Age:

80 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Irene Gottlob, Prof., MD Principal Investigator University of Leicester, Leicester, United Kingdom
Location
Facility: University of Leicester, Leicester Royal Infirmary, Ophthalmology Group
Location Countries

United Kingdom

Verification Date

2009-11-01

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: 1

Type: Other

Label: 2

Type: Other

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

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