Efficacy and safety of neramexane mesylate in congenital idiopathic nystagmus and acquired nystagmus: a randomized, double-blind, placebo-controlled, single center, proof of concept study using a two-period cross-over design.
- Conditions
- Congenital idiopathic nystagmus and acquired nystagmusMedDRA version: 9.1 Level: LLT Classification code 10029864 Term: NystagmusMedDRA version: 9.1 Level: LLT Classification code 10029867 Term: Nystagmus congenital
- Registration Number
- EUCTR2007-002595-34-GB
- Lead Sponsor
- Merz Pharmaceuticals GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 48
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
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 <90 mmHg and/or DBP <50 mmHg), and/or orthostatic dysregulation at the second baseline visit (Visit 5, Period 2) will be excluded from further trial participation.
• diseases affecting the vestibular organ in the inner ear;
• 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), including, but not limited to epilepsy, infranuclear disorders such as benign paroxysmal positional vertigo (BBPV), vestibular neuritis, Menière’s disease, superior canal dehiscence syndrome, vestibular paroxysmia, or superior oblique myokymia;
• nystagmus due to tumor lesions (e.g. pituitary tumors);
• nystagmus due to inflammatory processes other than MS;
• patients with known hypersensitivity or intolerance to neramexane, amantadine, or memantine; patients with intake of non-permitted concomitant medication;
• prior exposure to gabapentin or memantine for the treatment of nystagmus (patients treated with these medications in the past for other reasons may be enrolled if last dose administered at least 1 month before screening visit);
• simultaneous participation in another clinical trial or participation in any clinical research study evaluating another investigational compound within 3 months prior to screening;
• patients with evidence of clinically significant and active pulmonary, gastrointestinal, renal, hepatic, endocrine, psychiatric or cardiovascular system disease (patients with medically controlled stable hypertension and/or diabetes may be enrolled);
• patients with uncontrolled arterial hypertension (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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method