Effect of MD1003 in progressive multiple sclerosis with walking impairment

Phase 1

• Conditions: Progressive spinal multiple sclerosis; MedDRA version: 18.0Level: PTClassification code 10053395Term: Progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2013-002113-35-FR
• Lead Sponsor: MEDDAY SAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-29
• Study Completion: 2020-06-04
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

1) Diagnosis criteria of secondary or primary progressive MS with clinical or radiological evidence of spinal cord involvement fulfilling revised MacDonald criteria (2010) and Lublin criteria (1996)
2) Progression of the EDSS of at least 0.5 point during the past two years
3) EDSS score between 4.5 and 7 (measured beside a relapse and confirmed at 6 months)
4) Informed consent
5) Patient aged 18-64 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 105
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Any general chronic handicapping disease other than MS
2) Intensive physical therapy program within the 3 months prior to inclusion
3) Differences of the TW25 mean score between screening and baseline above 20%
4) New treatment introduced less than 3 months prior to inclusion or less than 1 month for Fampridine
5) Pregnancy or childbearing potential woman without contraception

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified