Un nuovo sintomo (Italian Edition)

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Date on which this record was first entered in the EudraCT database:. A phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the safety and efficacy of NU in patients with relapsing forms of multiple sclerosis.

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Studio di Fase III, multicentrico, in doppio cieco, randomizzato, controllato con placebo, a gruppi paralleli, volto a valutare la sicurezza e l'efficacia di NU in pazienti con forme recidivanti di sclerosi multipla. Title of the trial for lay people, in easily understood, i.

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A clinical trial to test if NU is safe and can treat patient with relapsing types of multiple sclerosis. Studio clinico che testa se NU e' sicuro ed efficace nel trattamento di pazienti con forme recidivanti di sclerosi multipla. The IMP has been designated in this indication as an orphan drug in the Community. Committee on Advanced therapies CAT has issued a classification for this product.

Combination product that includes a device, but does not involve an Advanced Therapy. To evaluate the safety and efficacy of NU in patients with relapsing remitting multiple sclerosis as compared to placebo and an active comparator. The primary clinical objective selected for this Phase 3 study, the cumulative number of new combined unique active lesions CALs; defined as new gadolinium T1-weighted lesions and non enhancing new and newly enlarging T2-weighted lesions on magnetic resonance imaging MRI scans over the course of 4 and 12 months of treatment to demonstrate the superiority of NU to placebo and the non-inferiority of NU to Betaferon, respectively.

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Patients will be eligible to participate in the study if all of the following criteria are met at both screening V-1 and baseline V0: Female or male patients, aged between 18 and 60 years, inclusive 2. Signed and dated statement of informed consent 3.

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No relapse in the 4 weeks prior to the screening visit V Must be in a clinically stable or improving neurological state 4 weeks preceding the screening visit V Criteri di inclusione I pazienti saranno ritenuti idonei a partecipare allo studio se sono soddisfatti tutti i seguenti criteri, allo screening V-1 come al basale V0: From Malicious to Redemptive Violence. Loss and Community Against the Ethics of Power.

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