Efficacy and Safety Study of Neramexane to Treat Congenital and Acquired Nystagmus
Status and phase
Completed
Phase 2
Conditions
Nystagmus, Congenital Idiopathic
Nystagmus, Acquired
Treatments
Drug: Neramexane mesylate
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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.
Enrollment
48 estimated patients
Sex
All
Ages
18 to 80 years old
Volunteers
No Healthy Volunteers
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)
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
Double Blind
48 participants in 2 patient groups
1
Other group
Treatment:
Drug: Neramexane mesylate
2
Other group
Treatment:
Drug: Neramexane mesylate
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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