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Clinical Trials/NCT00799942
NCT00799942TerminatedPhase 2

Long-term Open-label Extension Study to Assess the Safety, Tolerability, and Efficacy of Neramexane Mesylate in Congenital Idiopathic Nystagmus and Acquired Nystagmus

Merz Pharmaceuticals GmbH2 sites in 1 country48 target enrollmentStarted: May 2009Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Terminated
Enrollment
48
Locations
2
Primary Endpoint
Long-term safety, Visual acuity

Study Overview

Brief Summary

The purpose of this study is to investigate the long-term safety, tolerability and efficacy of neramexane mesylate in the treatment of congenital idiopathic nystagmus (CIN). In addition, a subgroup of multiple sclerosis (MS) patients suffering from acquired nystagmus will be included.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 81 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • patients who has succesfully completed the lead-in study MRZ 92579-0707/1

Exclusion Criteria

  • Occurence of any major treatment-emergent adverse event or condition during the previous protocol (MRZ 92579-0707/1)

Outcomes

Primary Outcomes

Long-term safety, Visual acuity

Time Frame: Baseline, week 4, month 3, 6, 9, 12, 18, 24, 30, 36 and follow-up

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry

Study Sites (2)

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