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

NCT ID: NCT01450488

Last Updated: 2018-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2010-01-31

Brief Summary

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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

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Conditions

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Multiple Sclerosis

Keywords

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primary progressive multiple sclerosis relapse-free secondary progressive multiple sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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masitinib 3 mg/kg/day

Group Type EXPERIMENTAL

masitinib

Intervention Type DRUG

masitinib 3 mg/kg/day

masitinib 6 mg/kg/day

Group Type EXPERIMENTAL

masitinib

Intervention Type DRUG

masitinib 6 mg/kg/day

Interventions

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masitinib

masitinib 3 mg/kg/day

Intervention Type DRUG

masitinib

masitinib 6 mg/kg/day

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AB Science

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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Vermersch P, Benrabah R, Schmidt N, Zephir H, Clavelou P, Vongsouthi C, Dubreuil P, Moussy A, Hermine O. Masitinib treatment in patients with progressive multiple sclerosis: a randomized pilot study. BMC Neurol. 2012 Jun 12;12:36. doi: 10.1186/1471-2377-12-36.

Reference Type RESULT
PMID: 22691628 (View on PubMed)

Related Links

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https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3467179/

Link to article

Other Identifiers

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AB04011

Identifier Type: -

Identifier Source: org_study_id