optic neuritis
Conditions
Interventions
Product Name: Minocyclin-ratiopharm 100 mg
Pharmaceutical Form: Capsule, hard
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Sponsors
HUCH Eye Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The subject has to fulfil the following criteria at the time of randomization: • The subject must give written informed consent prior to study activities • Age between 18 and 50 years • Has acute optic neuritis where the symptoms has lasted less than ten days and the visual acuity is less than 0.5 in either eye with best correction (standard criterion for conrticosteroid treatment). Subjects with optic neuritis as the first demyelinative event and subjects with previous diagnosis of MS with first optic neuritis are eligible • Pre-study MRI shows at least one white matter lesion of more than >3mm in diameter. 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 150 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The subject must not be included if she/he fulfills any of the criteria at the time of randomization as mentioned below: • Any condition which might cause similar symptoms as MS • Has alcohol or drug abuse • Has contraindications to MRI • Has received treatment with steroids or ACTH later than 30 days before inclusion • Has had a relapse within 30 days prior to inclusion into this study • The patient has participated in any other clinical studies within 30 days prior to participating in the study • Patient is pregnant or breast-feeding or planning pregnancy - women in fertile age should have adequate contraception or be otherwise unlikely to become pregnant • Has been treated with interferons, azathioprine, mitoxantrone or glatiramer acetate six months before entering the study • Has elevated liver enzymes or has a known liver disease - SGOT/SGPT over two times the upper normal limit • Has known allergy to minocycline or other tetracyclines • Previous optic neuritis • Marked obesity (BMI>30) (risk of intracranial hypertension with tetracycline use)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the efficacy of minocycline in the treatment of optic neuritis as measured by visual acuity;Secondary Objective: ;Primary end point(s): • The primary endpoint is the visual acuity measured by using ETDRS chart at 6 months. o Mean change in ETDRS points o Number of patients with >15 points decrease in ETDRS points ;Timepoint(s) of evaluation of this end point: At Pre-Study / Baseline visit, 1 month visit and 6 month visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The number of new or enlarging lesions in T2 weighted MRI compared to baseline MRI. • The white matter lesion load (WMLL) in MRI compared to baseline. • The use of high-dose glucocorticoid treatment for relapses (0-24 months). • The number of patients without relapse at the end of study • Mean change in visual evoked potentials (VEP) P100 response at 6 months. Safety endpoints • The occurrence of serious adverse events during the active treatment period • The occurrence of adverse drug reactions during the active treatment period • Changes in laboratory parameters evaluated throughout the study ;Timepoint(s) of evaluation of this end point: Patients have routinely MRI in pre-study and study related MRI at 6 month visit | — |
Countries
Finland
Outcome results
None listed