Long-Term treatment of Nystagmus with neramexane mesylate, Vers. Final

• Research type

  Research Study

• Full title

  A Long-Term Open Label Extension Study to assess the Safety, Tolerability and Efficacy of neramexane mesylate in congenital idiopathic nystagmus and acquired nystagmus.

• Contact name

• Sponsor organisation

  Merz Pharmaceuticals GmbH

• Eudract number

  2007-007663-25

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Idiopathic nystagmus is anon-serious, but long-lasting if not life-long medical condition for which sofar no approved pharmacological treatment modalities are available. In allpatients, visual acuity (VA) is reduced. The disease can have an importantimpact on everyday??s activities (e.g. reading, driving a car, computer work,etc.) and social functions. So far, no drug is approved for the treatment ofnystagmus. Neramexane will be first investigated in a short-term study andcompared against placebo treatment. Only patients who successfully completedthis study and showed some benefit in the judgement of the investigator will beasked to participate in this long-term trial with neramexane. The purpose ofthe study is to evaluate the long-term safety and tolerability of daily dosesof 25,50,75 mg neramexane mesylate in the treatment of congenital idiopathicnystagmus or secondary nystagmus in multiple sclerosis patients. The study willalso investigate the permanence of visual acuity improvement (long-termefficacy).

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  08/H0402/104

• Date of REC Opinion

  17 Nov 2008

• REC opinion

  Further Information Favourable Opinion