We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Masitinib in Patients With Primary Progressive Multiple Sclerosis (PPMS) or Relapse-free Secondary Progressive Multiple Sclerosis (SPMS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01450488
First Posted: October 12, 2011
Last Update Posted: October 12, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AB Science
  Purpose
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.

Condition Intervention Phase
Multiple Sclerosis Drug: masitinib Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by AB Science:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • MSFC subcategories [ Time Frame: 12 months ]
    timed 25-foot walk (T25FW)

  • Expanded Disability Status Scale (EDSS) [ Time Frame: 12 months ]
  • MFSC subcategories [ Time Frame: 12 months ]
    9-Hole Peg Test (9-HPT)

  • MFSC subcategories [ Time Frame: 12 months ]
    Paced Auditory Addition Test (PASAT-3'')


Enrollment: 35
Study Start Date: June 2005
Study Completion Date: January 2010
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: masitinib 3 mg/kg/day Drug: masitinib
masitinib 3 mg/kg/day
Experimental: masitinib 6 mg/kg/day Drug: masitinib
masitinib 6 mg/kg/day

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: AB Science
ClinicalTrials.gov Identifier: NCT01450488     History of Changes
Other Study ID Numbers: AB04011
First Submitted: October 6, 2011
First Posted: October 12, 2011
Last Update Posted: October 12, 2011
Last Verified: October 2011

Keywords provided by AB Science:
primary progressive multiple sclerosis
relapse-free secondary progressive multiple sclerosis

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Recurrence
Multiple Sclerosis, Chronic Progressive
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Disease Attributes