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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of memantine versus placebo on visual functions of patient with optic neuritis
Scientific title
In patients with optic neuritis, is Memantine as good as or better than placebo for improving visual functions?
Secondary ID [1] 253275 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
isolated optic neuritis 258723 0
optic neuritis 258724 0
Condition category
Condition code
Eye 258876 258876 0 0
Diseases / disorders of the eye

Study type
Description of intervention(s) / exposure
Memantine tablets for treatment group for 3 weeks orally(5mg/day for the first week and 10 mg/ day for the next two weeks)
Intervention code [1] 257674 0
Treatment: Drugs
Comparator / control treatment
Oral administration of placebo (550 miligram of lactose powder) for control group, daily for three weeks (550 mg per day for 3 weeks).
Control group

Primary outcome [1] 259736 0
visual acuity, testing by Early Treatment Diabetic Retinopathy Study (ETDRS) chart in LogMAR (Logarithmic value for Minimum Angle of Resolution)
Timepoint [1] 259736 0
Baseline, 3 months after randomisation
Primary outcome [2] 259737 0
Any change in NFL thickness measured by optical coherence tomography (OCT)
Timepoint [2] 259737 0
baseline, 3months after randomisation
Secondary outcome [1] 266473 0
Amplitudes of P waves measured by performing visual evoked potential
Timepoint [1] 266473 0
baseline, 3 months after randomisation

Key inclusion criteria
Isolated acute optic neuritis with duration of less than 8 days as patient declares
Minimum age
10 Years
Maximum age
50 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
anti-convulsants, barbiturates, neuroleptics, Amantadine hydrochlorothiazids, digoxin and dextrometorphan (interacting with memantine)
Pregnancy or nursing
Renal disease

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation by using a randomisation table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Subjects, therapist or clinician, assessor, and data analyst were all masked
Phase 2 / Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Active, not recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 3070 0
Iran, Islamic Republic Of
State/province [1] 3070 0

Funding & Sponsors
Funding source category [1] 258148 0
Name [1] 258148 0
Tehran University, Ophthalmology department/ School of medicine/ Medical Sciences
Address [1] 258148 0
Farabi Eye Hospital, Kargar Ave., Qazvin Square, Tehran 1336616351
Country [1] 258148 0
Iran, Islamic Republic Of
Primary sponsor type
Tehran University of Medical sciences
Tehran university, Enghelab Ave., Enghelab Square, Tehran
Iran, Islamic Republic Of
Secondary sponsor category [1] 257370 0
Name [1] 257370 0
Address [1] 257370 0
Country [1] 257370 0

Ethics approval
Ethics application status
Ethics committee name [1] 260126 0
The investigational review board and ethics committees of Tehran University of Medical Sciences
Ethics committee address [1] 260126 0
Tehran University eye research center, Farabi eye hospital, Kargar Ave., Qazvin Sq., Tehran 1336616351
Ethics committee country [1] 260126 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 260126 0
Approval date [1] 260126 0
Ethics approval number [1] 260126 0

Brief summary
Evaluation of the neuroprotective effect of Memantine in visual function of patients with optic neuritis. Our hypothesis was that Memantine helps for better improvement of visual function in acute optic neuritis.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 31960 0
Address 31960 0
Country 31960 0
Phone 31960 0
Fax 31960 0
Email 31960 0
Contact person for public queries
Name 15207 0
Mohammad Riazi-Esfahani MD
Address 15207 0
Farabi Eye Hospital, Kargar Ave., Qazvin Square, Tehran 1336616351
Country 15207 0
Iran, Islamic Republic Of
Phone 15207 0
+98 9121446987
Fax 15207 0
+98 21 22678090
Email 15207 0
Contact person for scientific queries
Name 6135 0
Mohammad Riazi-Esfahani MD
Address 6135 0
Farabi Eye Hospital, Kargar Ave., Qazvin Square, Tehran 1336616351
Country 6135 0
Iran, Islamic Republic Of
Phone 6135 0
+98 9121446987
Fax 6135 0
+98 21 22678090
Email 6135 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary