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

December 8, 2018 updated by: AB Science

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: masitinib 3 mg/kg/day
Drug: masitinib
masitinib 3 mg/kg/day
Drug: masitinib
masitinib 6 mg/kg/day
Experimental: masitinib 6 mg/kg/day
Drug: masitinib
masitinib 3 mg/kg/day
Drug: masitinib
masitinib 6 mg/kg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MSFC subcategories
Time Frame: 12 months
timed 25-foot walk (T25FW)
12 months
Expanded Disability Status Scale (EDSS)
Time Frame: 12 months
12 months
MFSC subcategories
Time Frame: 12 months
9-Hole Peg Test (9-HPT)
12 months
MFSC subcategories
Time Frame: 12 months
Paced Auditory Addition Test (PASAT-3'')
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AB Science

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

October 6, 2011

First Submitted That Met QC Criteria

October 10, 2011

First Posted (Estimate)

October 12, 2011

Study Record Updates

Last Update Posted (Actual)

December 11, 2018

Last Update Submitted That Met QC Criteria

December 8, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AB04011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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