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

Nystagmus, Acquired Clinical Trial

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-period Cross-over Design

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00661440
• Other study ID #: MRZ 92579-0707/1
• Secondary ID: EudraCT Number 2
• Status: Completed
• Phase: Phase 2
• First received: April 15, 2008
• Last updated: November 25, 2009
• Start date: May 2008

Study information

• Verified date: November 2009
• Source: Merz Pharmaceuticals GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nystagmus, Acquired
• Nystagmus, Congenital
• Nystagmus, Congenital Idiopathic

Intervention

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

Locations

Country	Name	City	State
United Kingdom	University of Leicester, Leicester Royal Infirmary, Ophthalmology Group	Leicester

Sponsors (1)

Lead Sponsor	Collaborator
Merz Pharmaceuticals GmbH

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity		Screening, Baseline, Week 3, 7, 11, 14, 18, and Follow-up	No
Secondary	nystagmus intensity, expanded nystagmus acuity function, reading ability, questionnaires, safety parameter