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A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the trea...

Mise à jour : Il y a 4 ans
Référence : EUCTR2010-021219-17

A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis AB07002: 96 TÝŽDŇOVÁ, PROSPEKTÍVNA, MULTICENTRICKÁ, RANDOMIZOVANÁ, DVOJITO ZASLEPENÁ, PLACEBOM KONTROLOVANÁ ŠTÚDIA 3. FÁZY 2 PARALELNÝCH SKUPÍN, POROVNÁVAJÚCEJ ÚČINNOSŤ A BEZPEČNOSŤ MASITINIBU V DÁVKE 4,5 MG / KG / DEŇ PROTI PLACEBU PRI LIEČBE PACIENTOV S PRIMÁRNOU PROGRESÍVNOU SKLERÓZOU MULTIPLEX ALEBO SEKUNDÁRNE PROGRESÍVNOU SKLERÓZOU MULTIPLEX BEZ RELAPSOV

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Extrait

The objective of the study is to compare the safety and efficacy of masitinib at 4.5 mg/kg/day or masitinib at 4.5 mg/kg/day with a dose escalation to 6 mg/kg/day after three month of treatment versus placebo in the treatment of patients with primary progressive multiple sclerosis or relapse-free secondary progressive multiple sclerosis. Primary endpoint: Multiple Sclerosis Functional Composite (MSFC) at week 96

Critère d'inclusion

  • Primary progressive or relapse-free secondary progressive multiple sclerosis

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