E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Optic neuritis. |
Synsnervebetændelse. |
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E.1.1.1 | Medical condition in easily understood language |
Inflammation of the optic nerve. |
Synsnervebetændelse. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10030946 |
E.1.2 | Term | Optic neuritis, unspecified |
E.1.2 | System Organ Class | 100000004852 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To see if early treatment of acute optic neuritis with high-dosis intravenous Solu-medrol, has effect on visual function at follow-up 6 months and 12 months later. |
At se om tidlig behandling af akut opticus neurit med højdosis intravenøs Solu-medrol har effekt på synet ved follow-up 6 mdr og 12 mdr senere.
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E.2.2 | Secondary objectives of the trial |
Not applicable. |
Ikke relevant. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Optic neuritis diagnosed by ophthalmologist. - Visual acuity 6/12 (0,50) or worse, and/or bilateral optic neuritis. 2) Age >18 years. |
1) Opticus neurit diagnosticeret ved speciallæge i øjensygdomme. - Syn 6/12 (0,50) eller dårligere, og/eller bilateral opticus neurit. 2) Alder >18 år.
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E.4 | Principal exclusion criteria |
1) Persons not of age, and persons without ability to give informed concent. 2) Pregnant. 3) Patients with a large alcohol consumption. 4) Patients with clinically relevant neurological, cardiovascular, hepatic, endocrine or other severe systemic diseases, that can make implementation of protocol and interpretation of results difficult, or that will put the patient at risk by participating. 5) The following eyediseases: Glaucoma, refraction error of at least 8,0 dioptries, anterior ischaemic opticus neuropathy, retinitis pigmentosa, congenital abnormalities in the optic nerve, previous retinal surgery, previous retinal infection, previous retinal vein occlusion, cataract surgery within the last year and intraocular malign disease. |
1) Ikke myndige personer og personer med manglende evne til at give informeret samtykke. 2) Gravide. 3) Patienter med stort alkoholforbrug. 4) Patienter med klinisk relevante neurologiske, kardiovaskulære, hepatiske, endokrine eller andre alvorlige systemiske sygdomme, som kan gøre implementering af protokol og tolkning af resultater svært, eller som vil udsætte patienten for risiko ved deltagelse i forsøget. 5) Følgende øjensygdomme: Glaukom, refraktionsfejl på mindst 8,0 D, anterior iskæmisk opticus neuropati, retinitis pigmentosa, kongenitte abnormiteter i n. opticus, tidligere operation på retina, tidligere infektion i retina, tidligere retinal veneokklusion, kataraktoperation indenfor det sidste år og intraokulær malignitet.. |
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E.5 End points |
E.5.1 | Primary end point(s) |
1) Retinal nerve fiber layer thickness. 2) Visual acuity.
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1) Tykkelsen af retinas nervefiber lag. 2) Visus. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Follow-up at 6 months and 12 months. |
Follow-up ved 6 mdr og 12 mdr. |
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E.5.2 | Secondary end point(s) |
Contrast sensitivity, colour vision, visual field, appearance of optic nerve papil, vascular changes in retina, changes in retina's inner nuclear layer, visual evoked potentials, MRI changes in brain and spinal cord, NMO-IgG in blood, Extended Disability Status Scale (EDSS) score. |
Kontrast sensitivitet, farvesyn, synsfelt, udseende af papil, vaskulære forandringer i retina, forandringer i retinas indre kernelag, ledningshastighed i synsnerven, MR forandringer i hjerne og rygmarv, NMO-IgG i blod, EDSS score. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
6 and 12 months. |
6 og 12 mdr. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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LVLS |
Sidste patient, sidste besøg. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |