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OpenTrials
Completed

NCT Number: NCT01450488

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Immune System Diseases Multiple Sclerosis, Chronic Progressive Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Patients with EDSS score in the range of 2 to 6.5, inclusive
  • EDSS progression ≥ 1 point within 2 years before inclusion

Exclusion criteria

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

Treatment and study plan

Masitinib

Drug

masitinib 3 mg/kg/day

Primary outcomes

  1. change in MSFC

    Time frame: 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 outcomes

  1. MSFC subcategories

    Time frame: 12 months

    timed 25-foot walk (T25FW)

  2. Expanded Disability Status Scale (EDSS)

    Time frame: 12 months

  3. MFSC subcategories

    Time frame: 12 months

    9-Hole Peg Test (9-HPT)

  4. MFSC subcategories

    Time frame: 12 months

    Paced Auditory Addition Test (PASAT-3'')

Sponsors and collaborators

Lead sponsor

AB Science

Industry

Registry information

Official study title

A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Activity of Oral AB1010 Administered at 2 Dose Levels to Patients With Primary Progressive or Relapse-free Secondary Progressive Multiple Sclerosis

Important dates

Study start
2005
Primary completion
2007
Study completion
2010
First posted
Oct 12, 2011
Registry last updated
Dec 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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