Open-lable Extension Study on Safety and Efficacy of Neramexane to Tre
Long-term Open-label Extension Study to Assess the Safety, Tolerability, and Efficacy of Neramexane Mesylate in Congenital Idiopathic Nystagmus and Acquired Nystagmus
What it found
The trial ended early for another reason (see below).
What was tested
Treatment tested
- Neramexane
What it measured
Main measures
Long-term safety, Visual acuity
Baseline, week 4, month 3, 6, 9, 12, 18, 24, 30, 36 and follow-up
VisionSafetyThe primary objective of this open-label, extension study is to evaluate the long-term safety and tolerability of daily doses of 25, 50, or 75 mg neramexane mesylate in the treatment of CIN or nystagmus secondary to multiple sclerosis. A further objective of the trial will be to investigate the permanence of visual acuity improvement.
VisionSafety
Who could take part
MS (type not specified) · 18 to 81
Show the full criteria
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)
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
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History
Started
May 2009