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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-000490-37-IT

Enrollment

Registered

2008-03-20

Start date

2008-02-26

Completion date

Unknown

Last updated

2021-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

multiple sclerosis MedDRA version: 9.1 Level: LLT Classification code 10028053 Term: MS

Interventions

Trade Name: EBIXA Pharmaceutical Form: Oral drops, solution INN or Proposed INN: Memantine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form o

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026