A Phase 2a Magnetic Resonance Imaging Study of the Safety and Efficacy of MLN1202 in Patients in Multiple Sclerosis

NCT01199640 Phase 2 COMPLETED

This was a phase 2a study of MLN1202 to determine safety, tolerability and initial efficacy in patients with relapsing-remitting multiple sclerosis (RRMS). It was conducted in 2 dose cohorts enrolling a total of 50 patients. Efficacy was assessed by comparing the numbers of new gadolinium-enhancing brain lesions during the screening and treatment periods.

Details

Lead sponsor	Millennium Pharmaceuticals, Inc.
Phase	Phase 2
Status	COMPLETED
Enrolment	50
Start date	2005-05
Completion	2007-10

Conditions

• Multiple Sclerosis

Interventions

• MLN1202

Primary outcomes

• To determine the safety and tolerability of MLN1202 in patients with relapsing-remitting multiple sclerosis (RRMS) — Day 61- Day 330
  Vital sign measurement, physical examinations, multiple sclerosis (MS) relapses, changes in expanded disability status scale (EDSS) scores and standard laboratory test results, as well as the incidence of adverse events and serious adverse events
• To determine the efficacy of MLN1202 in patients with RRMS — Day 0- Day 180
  Comparing the mean number of new gadolinium-diethylenetriamine pentaacetic acid (Gd)-enhancing lesions on magnetic resonance imaging (MRI) scans during the pretreatment phase with the mean number of new Gd-enhancing lesions found during the treatment phase