E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
clinical isolated syndrome |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028248 |
E.1.2 | Term | Multiple sclerosis-like syndrome |
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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 assess the feasibility of optical coherence tomography (OCT) measurement in patient with CIS other than optic neuritis (ON) or in patients with early MS in the Dutch clinical setting by qualitative evaluation |
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E.2.2 | Secondary objectives of the trial |
To assess the efficacy of GA on the Retinal Nerve Fiber Layer (RNFL) and visual function in patients with CIS as determined by the mean change in RNFL |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Age: 18 – 45 years • Early RRMS, defined as a disease course less than 3 years • CIS other than ON • Expanded disability status scale (EDSS) score 0-4 • Able and willing to provide written informed consent prior to enrolment • Willing and able to comply with the protocol requirements for the duration of the study
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E.4 | Principal exclusion criteria |
• Clinical definite multiple sclerosis (CDMS) with a disease course more than 3 years • Acute ON or a history of ON • Primary progressive multiple sclerosis • Secondary progressive multiple sclerosis • Current use of any approved or investigational disease modifying agents for the treatment of MS. • Neuromyelitis Optica (Devic’s disease) • Any condition that may interfere with the quality of the OCT scan: clouding of the media, e.i. cataract, pupil which are hard to dilate. • Contra-indications for Copaxone ® as defined in the Summary of Product Characteristics (SPC) text • Hypersensitivity to GA or mannitol • Subject's inability to complete the study or if the subject is considered by the investigator to be for any reason, an unsuitable candidate for this study.
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E.5 End points |
E.5.1 | Primary end point(s) |
• Feasibility of OCT measurement in patient with CIS other than ON or with early RRMS in the Dutch clinical setting. • Mean change in RNFL in both eyes determined by OCT at baseline, month 3, month 6, month 9, month 12.
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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 | Yes |
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 | Yes |
E.8.1.1 | Randomised | Yes |
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 | 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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 3 |
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 | 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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |