Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000350921
Ethics application status
Approved
Date submitted
12/12/2010
Date registered
5/04/2011
Date last updated
5/04/2011
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
Nil
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

Intervention/exposure
Study type
Interventional
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
Placebo

Outcomes
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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
Treatment
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
Parallel
Other design features
Subjects, therapist or clinician, assessor, and data analyst were all masked
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/04/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 3070 0
Iran, Islamic Republic Of
State/province [1] 3070 0

Funding & Sponsors
Funding source category [1] 258148 0
University
Name [1] 258148 0
Tehran University, Ophthalmology department/ School of medicine/ Medical Sciences
Country [1] 258148 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Tehran University of Medical sciences
Address
Tehran university, Enghelab Ave., Enghelab Square, Tehran
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 257370 0
None
Name [1] 257370 0
Address [1] 257370 0
Country [1] 257370 0

Ethics approval
Ethics application status
Approved
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

Summary
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

Contacts
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
mriazi@sinatums.ac.ir
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
mriazi@sina.tums.ac.ir

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
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