Clinical Trial: Efficacy and Safety Study of Neramexane to Treat Congenital and Acquired Nystagmus

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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-

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 Summary:
Sponsor: Merz Pharmaceuticals GmbH

Current Primary Outcome: Visual acuity [ Time Frame: Screening, Baseline, Week 3, 7, 11, 14, 18, and Follow-up ]

Original Primary Outcome: Same as current

Current Secondary Outcome: nystagmus intensity, expanded nystagmus acuity function, reading ability, questionnaires, safety parameter

Original Secondary Outcome: Same as current

Information By: Merz Pharmaceuticals GmbH

Dates:
Date Received: April 15, 2008
Date Started: May 2008
Date Completion:
Last Updated: November 25, 2009
Last Verified: November 2009