Masitinib in patients with primary progressive or secondary progressive multiple sclerosis

Phase 3

• Conditions: Multiple sclerosis; Nervous System Diseases; Patients with primary progressive or secondary progressive multiple sclerosis without relapse

• Registration Number: ISRCTN93303620
• Lead Sponsor: Dokumeds

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-20
• Last Update Posted: 20 June 2022
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

1. Patients with either primary progressive or secondary progressive multiple sclerosis with onset of symptoms at least five years before inclusion and with no relapse diagnosed according to the 2017 revised McDonald’s criteria at least two years before screening
2. Patients with Expanded Disability Status Scale (EDSS) score between 3.0 to 6.0 (both inclusive) at screening and baseline
3. Patients with an EDSS score progression =1 point with no improvement during 2 years before screening
4. Absence of T1 Gadolinium-enhancing brain lesions at baseline as measured by MRI at screening

Exclusion Criteria

1. Patients suffering from a disease other than MS that would better explain the patient’s neurological clinical signs and symptoms and/or MRI lesions observed at screening
2. Inability to complete screening MRI (contraindications for MRI) and/or any known allergy or hypersensitivity or any contra-indication to gadolinium macrocyclic
3. Patients treated with other disease modifying treatments in the time frames and conditions mentioned under previous treatment wash out period, assessed at baseline
4. Patients with lymphocytes <1.0 × 10^9/L at screening and at baseline

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to confirmed (12-weeks CDP [Confirmed Disability Progression]) Expanded Disability Status Scale (EDSS) progression. The EDSS progression is defined as 1-point worsening when EDSS baseline score =5.5 or 0.5 if baseline score >5.5 from randomization to Week 96.