Pharmacological treatment with memantine of oscilloscopy in patients suffering from multiple sclerosis: randomized,double blind placebo controlled study. - ND

Phase 1

• Conditions: multiple sclerosis; MedDRA version: 9.1Level: LLTClassification code 10028053Term: MS

• Registration Number: EUCTR2008-000490-37-IT
• Lead Sponsor: OSPEDALE S. RAFFAELE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-03-20
• Last Update Posted: 26 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

male or female aged 18-60 yrs
diagnosis of Multiple Sclerosis (any course of disease)
presence of nystagmus associated with oscillopsy (as reported by the patient)
no MS relapse within the last 3 months and/or deterioration of >1.0 at EDSS scale in the last 6 months prior to enrolment
Oscillopsy is present at least for 25% of daytime as assessed with specific ordinal questionary for patients
Visual Acuity greater than 2/10 in the worst eye
Patients have signed the informed consent form to participate the study
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

current treatment with GABAergic drugs from at least 30 days prior to baseline visit
involvement in any other experimental pharmacological treatment in the previous 3 months
clinical history of epilepsy, Coronaric Heart Disease, pregnancy, uncontrolled hypertension, moderate renal failure

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the efficacy of memantine on symptomatic oscillopsy by means of the VAS and the Snellen Visual Scale (SVS). The primary end point is the reduction of symptoms (VAS score);Secondary Objective: Secondary End Point is a reduction of physical parameter of Nystagmus (amplitude, frequency, speed and rythm) and improving of Fixation Index (FI), as measured with Videoculography (VOG). Reading test.;Primary end point(s): the primary outcome measure will be a reduction of > 33% of oscilloscopy as assessed by the VAS and improvement of visual acuity assessed by SVS.