Masitinib in Primary Progressive Multiple Sclerosis or Relapse-free Secondary Progressive Multiple Sclerosis

Phase 2

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: masitinib

• Registration Number: NCT01450488
• Lead Sponsor: AB Science

Brief Summary

The purpose of this study is to evaluate the activity of oral AB1010, administered at two dose levels during 3 years to patients with primary or secondary progressive multiple sclerosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Primary Completion: 2007-07
• Study Completion: 2010-01
• Study First Submitted: 2011-10-06
• Study First Submitted QC: 2011-10-10
• Study First Posted: 2011-10-12
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-08
• Last Update Posted: 2018-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1. Patients aged 18 to 60 years, from both sex, and suffering from multiple sclerosis either primary progressive or secondary progressive without relapse within 2 years before inclusion.
2. Patients with EDSS score in the range of 2 to 6.5, inclusive
3. EDSS progression ≥ 1 point within 2 years before inclusion

Exclusion Criteria

1. Disease other than MS responsible for clinical signs and/or MRI lesions
2. Secondary progressive MS with relapse in the 2 years before inclusion
3. Treatment with interferon or glatiramer acetate within four weeks prior to treatment allocation
4. Treatment with oral or systemic corticosteroids or ACTH within four weeks prior to treatment allocation.
5. Active current bacterial, viral (including hepatitis B and C, HIV, EBV, CMV, herpes zoster, herpes simplex), fungal, mycobacterium, protozoan, or other infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
masitinib 3 mg/kg/day	masitinib	-
masitinib 6 mg/kg/day	masitinib	-

Primary Outcome Measures

Name	Time	Method
change in MSFC	12 months	average change in multiple sclerosis functional composite (MSFC) score relative to baseline, with clinical response defined as a \> 100% improvement (increase) from baseline

Secondary Outcome Measures

Name	Time	Method
MFSC subcategories	12 months	Paced Auditory Addition Test (PASAT-3'')
MSFC subcategories	12 months	timed 25-foot walk (T25FW)
Expanded Disability Status Scale (EDSS)	12 months