E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Synsnervebetændelse og Multiple Sklerose (MS) |
|
MedDRA Classification |
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 |
Formålet med forsøget er at undersøge, om behandlingen med simvastatin bedrer synsfunktionen 3 måneder efter inklusion i undersøgelsen og påvirker forandringer på MR scanning af cerebrum efter 3 måneder og 6 mndr. samt udvikling af nye demyelinisernde attakker. |
|
E.2.2 | Secondary objectives of the trial |
Hos patienter med monosymptomatisk opticusneuritis undersøges, om simvastatin reducerer risiko for udvikling af dissemineret sclerose. |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
• Diagnosticeret ON • Abnorm kontrastfølsomhed (score >80) • Varighed af ON højst 4 uger • Mænd og kvinder 18 år og 59 år Patienten skønnes fysisk og mentalt at kunne deltage i et forsøg af 6 må- neders varighed • Skriftlig informeret samtykke til deltagelse foreligger
|
|
E.4 | Principal exclusion criteria |
• Tidligere ON på samme øje • Graviditet • Amning • Fertile kvinder, der ikke bruger antikonception • Kvinder, der påtænker graviditet inden for forsøgsperioden • Patienter, der har været i behandling med steroider inden for de seneste 4 uger, samt patienter, for hvem behandling med steroider er plan-lagt på inklusionstidspunktet • Immunsupprimerende behandling inden for de seneste 6 måneder • Aktiv leversygdom eller vedvarende transaminaseforhøjelse af ukendt årsag. Svær nyreinsufficiens. Myopati • Hypothyreoidisme, Diabetes Melitus, Alkoholisme • Samtidig administration af fibrater (herunder gemfibrozil), Niacin, Ciclosporin, Itraconazol, Ketoconazol, Macrolid antibiotica, Nefazo-don, Verapamil, Diltiazem, Amiodaron og perorale antikoagulantia. • Aktuel behandling med statin eller indikation herfor. • Allergi mod indholdsstoffer i produktet • Samtidig deltagelse i andre lægemiddelafprøvninger |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Øjets kontrastfølsomhed efter 3 måneder. Udvikling af dissemineret sclerose efter 6 måneder.
|
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Information not present in EudraCT |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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
| |
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 | 6 |
E.8.9.1 | In the Member State concerned days | |