Congenital idiopathic nystagmus and acquired nystagmus MedDRA version: 9.1 Level: LLT Classification code 10029864 Term: Nystagmus MedDRA version: 9.1 Level: LLT Classification code 10029867 Term: Nystagmus congenital
Conditions
Sponsors
Merz Pharmaceuticals GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Only patients meeting all of the inclusion criteria and not presenting any of the exclusion criteria as listed will be considered for enrolment into the study. • patients with CIN or acquired nystagmus subsequent to MS; • male or female outpatients aged between 18 and 80 years (inclusive) at screening (visit 1); • patients with a nystagmus-related, best-corrected, reduced metric VA of 6/9 or worse (= 6/9); • for females of childbearing potential (last menses less than one year prior to enrolment): negative pregnancy test at screening and at baseline (i.e. prior to entry in the double-blind treatment phase); not breast-feeding; either surgically sterile or agreement to use a medically accepted, highly effective contraception during the entire duration of the study; • patients having given written informed consent prior to any testing under this protocol, including screening tests and evaluations that are not considered part of the patients’ routine care; • refraction done prior to enrolment, in particular in patients in whom the last refractive correction dates back to more than 12 months from screening. If required prescription and receipt of new glasses or contact lenses at least 2 weeks prior to the screening examination; • results of normal electrocardiogram (ECG) and safety laboratory at screening, or abnormal findings which are judged not clinically significant by the investigator; • absence of relevant medical disability or laboratory test results that, in the judgment of the investigator, would interfere with assessment of the tolerability, safety, or efficacy of the investigational compound or would compromise the patient's ability to provide informed consent; Congenital idiopathic nystagmus patients only: • normal results of electroretinography (ERG) and visually evoked potential (VEP) testing; historical results may be accepted if obtained according to International Society for Clinical Electrophysiology of Vision (ISCEV) standards within 3 years of the screening examination; • normal results of ophthalmological examination incl. slit lamp and funduscopy; Multiple sclerosis patients only: • diagnosis ‘multiple sclerosis’ as defined by 2005 Revisions to the McDonald criteria; neurologically stable with no evidence of acute relapse. • normal results of ophthalmological examination incl. slit lamp and funduscopy other than optic nerve atrophy; Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients in whom any of the following criteria applies at the first study visit, i.e. screening visit (Visit 1, Period 1) of the cross-over trial will be excluded from the study enrolment. Patients presenting with uncontrolled arterial hypertension (SBP >160 mmHg and/or DBP >100 mmHg), arterial hypotension (SBP 160 mmHg and/or DBP >100 mmHg), arterial hypotension (SBP <90 mmHg and/or DBP <50 mmHg), and/or orthostatic dysregulation; • patients with known active systemic bacterial, viral or fungal infections, or a known diagnosis of HIV or hepatitis C infection; • patients with an oncology diagnosis/malignancy (hematology or solid tumor) currently undergoing treatment, completion of such treatment within the past six months, or who still have evidence of active disease (except for successfully treated basal or squamous cell carcinoma of the skin); • known or suspected alcoholism or drug abuse; • unwillingness or inability to comply with the requirements of this protocol, including the presence of any condition that is likely to affect the patient’s returning for scheduled follow-up visits on schedule; • employees or direct relatives of an employee of the CRO, the investigational site or medical students of the University of Leicester or Merz Pharmaceuticals; patients who are lawfully kept in an institution or are imprisoned • any other condition which in the opinion of the investigator would compromise patient safety or interfere with the interpretation of study results; Multiple sclerosis patients only: • history of epi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this cross-over study will be to investigate the safety and efficacy of neramexane mesylate at daily doses of up to 75 mg (target dose, reduction to 50 mg will be allowed) in the treatment of CIN in comparison to placebo. In addition, a subgroup of up to 20 MS patients (or fewer patients in case 28 patients with CIN have already been randomized) suffering from acquired nystagmus will be included and analyzed in an exploratory manner.;Secondary Objective: ; Primary end point(s): The primary response variable in this trial will be the mean best corrected VA which will be measured prior to treatment initiation and at the end of each of the two treatment periods of the cross-over trial, i.e. after 7 weeks of treatment. The measurement will be performed at null point at distance (4m) using the LogMAR VA charts and with both eyes opened. Central VA is the clinically most relevant variable and represents the ‘gold standard’ by which the outcomes of drug therapy (or other interventions) are measured in this indication in the framework of clinical trials. In this study, LogMAR will be used as a primary response variable rather than the traditional Snellen notation. | — |
Countries
United Kingdom
Outcome results
None listed