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

AB Science

Status and phase: Completed; Phase 2

Conditions: Multiple Sclerosis

Treatments: Drug: masitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01450488

AB04011

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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35 participants in 2 patient groups

masitinib 3 mg/kg/day

Experimental group

Treatment:

Drug: masitinib

Drug: masitinib

masitinib 6 mg/kg/day

Experimental group

Treatment:

Drug: masitinib

Drug: masitinib