E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10029247 |
E.1.2 | Term | Neuritis optic |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10030946 |
E.1.2 | Term | Optic neuritis, unspecified |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10030942 |
E.1.2 | Term | Optic neuritis |
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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 determine whether high dose vitamin D treatment in optic neuritis can reduce axonal loss as measured by Optical Coherence Tomography (OCT) |
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E.2.2 | Secondary objectives of the trial |
- To investigate whether the occurrence of a second attack (defining clinically definite MS) is postponed in the vitamin D treatment group compared to placebo; - To investigate the effect of vitamin D treatment on visual outcome measures (visual acuity and visual field); - To investigate the effect of vitamin D treatment on clinical outcome measures (EDSS, MSIS, fatigue scales); - To investigate the effect of vitamin D treatment on immune and neurodegenerative markers in blood and CSF. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients fulfilling the following criteria are included: - Single unilateral optic neurits (ON) - Age between 18 and 50 year - Neuro-ophtalmological examination within 4 weeks of symptom onset Clinically confirmed ON is defined as fulfilling at least 4 of 5 of following criteria: pain with eye movement, sub-acute onset of decreased Snellen acuity, color vision loss, a relative afferent pupillary defect, and compatible fundus examination (i.e. mild or no optic edema and the absence of pallor at the time of the acute event). |
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E.4 | Principal exclusion criteria |
Patients are excluded who: - Have prior known ON, MS or prior symptoms suggestive of demyelination; - Have other suspected or established causes of vision loss (e.g. glaucoma, amblyopia); - Are unable to undergo OCT testing; - Use more than 1 vitamin supplement; - Have used immunomodulatory therapy (e.g. interferone) in the 3 months prior to inclusion; - Have had methylprednisolone treatment in the 3 months prior to inclusion; - Have an allergy to peanuts. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The main endpoint of this study is retinal nerve fiber layer thickness in optic neuritis patients with either vitamin D treatment of placebo, as measured by OCT. |
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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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
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
|
The end of the study is defined as the last patient’s last visit. |
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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 | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |