Clinical Trials Logo
  1. Home
  2. Multiple Sclerosis
  3. NCT02220244
  4. Details
NCT02220244 Clinical Trial

Effect of MD1003 in Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— MS-ON  

Official title:
Effect of MD1003 in Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis: a Pivotal Randomized Double Masked Placebo Controlled Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02220244
Other study ID # MD1003CT2013-01MS-ON
Secondary ID 2013-002112-27
Status Active, not recruiting
Phase Phase 3
First received August 18, 2014
Last updated March 23, 2017
Start date October 2013
Est. completion date January 2018

Study information
Verified date March 2017
Source MedDay Pharmaceuticals SA
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to demonstrate the superiority of MD1003 over placebo in the visual improvement of patients suffering from chronic visual loss resulting from multiple sclerosis related optic neuritis.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 105
Est. completion date January 2018
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

1. Diagnosis criteria of MS fulfilling revised Mc Donald criteria (2010)

2. Uni-or bilateral optic neuropathy with worst eye VA= 5/10 confirmed at 6 months

3. Worsening of visual acuity during the last three years

4. Informed consent prior to any study procedure

5. Patient aged 18-75 years

Exclusion Criteria:

1. Optic neuritis relapse within the three months before inclusion

2. Normal RNFL at OCT

3. Presence of other ocular pathology (glaucoma, cataract, retinopathy, anterior uveitis, myopia>7 dioptrics, intraocular pressure>20 mm Hg, amblyopia, retinal or optic head abnormalities (drusen, tilted disc)

4. Bilateral visual acuity <1/20

5. Visual impairment caused by ocular flutter or nystagmus

6. Pregnancy or childbearing potential woman without contraception

7. Any general chronic handicapping disease other than MS

8. New treatment introduced less than 3 months prior to inclusion or less than 1 month for Fampridine

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MD1003 100mg capsule

Locations
Country Name City State
France Hopital Pellegrin Bordeaux
France Hopital de la cote de Nacre Caen
France Hopital Gabriel Montpied Clermont Ferrand
France Hopital general du Bocage Dijon
France CHRU de Lille Lille
France Hopital Pierre Wertheimer Lyon
France Hopital de la Timone Marseille
France Hopital Gui de Chauliac Montpellier
France Hopital Central Nancy
France Hopital Nord Laennec Nantes
France Hopital Pasteur Nice
France Centre hospitalier national d'ophtalmologie des Quinze Vingts Paris
France Fondation Rothschild Paris
France Groupe hospitalier la Pitie-Salpetriere Paris
France Centre hospitalier Intercommunal Poissy/Saint-Germain-en-Laye Poissy
France Hopital Maison Blanche Reims
France Hopital Pontchaillou Rennes
France Hopital de Hautepierre Strasbourg
France Hopital Purpan Toulouse
United Kingdom UCL Institute of Neurology London

Sponsors (1)
Lead Sponsor Collaborator
MedDay Pharmaceuticals SA

Countries where clinical trial is conducted

France,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline of the best corrected visual acuity at 100% contrast Best corrected visual acuity using the ETDRS logMar chart at 100% contrast Baseline, 6 months
Secondary Visual field mean deviation change from baseline Visual field analyses are performed using the standard automated perimetry method Baseline, 6 months, 12 months
Secondary Reappearance or improvement of the P00 wave on Visual Evoked Potential Two parameters will be evaluated: (1) presence of a clear P100 wave, (2) P100 latency Baseline, 6 months, 12 months
Secondary Optical Coherence Tomography Values of RNFL thickness and macular volume Baseline, 6 months, 12 months
See also
  Status Clinical Trial Phase
Completed NCT05528666 - Risk Perception in Multiple Sclerosis
Completed NCT03608527 - Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis N/A
Recruiting NCT05532943 - Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis Phase 1/Phase 2
Completed NCT02486640 - Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon
Completed NCT01324232 - Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis Phase 2
Completed NCT04546698 - 5-HT7 Receptor Implication in Inflammatory Mechanisms in Multiple Sclerosis
Active, not recruiting NCT04380220 - Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
Completed NCT02835677 - Integrating Caregiver Support Into MS Care N/A
Completed NCT03686826 - Feasibility and Reliability of Multimodal Evoked Potentials
Recruiting NCT05964829 - Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis N/A
Withdrawn NCT06021561 - Orofacial Pain in Multiple Sclerosis
Completed NCT03653585 - Cortical Lesions in Patients With Multiple Sclerosis
Recruiting NCT04798651 - Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis N/A
Active, not recruiting NCT05054140 - Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis Phase 2
Completed NCT05447143 - Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis N/A
Recruiting NCT06195644 - Effect of Galvanic Vestibular Stimulation on Cortical Excitability and Hand Dexterity in Multiple Sclerosis Patients Phase 1
Completed NCT04147052 - iSLEEPms: An Internet-Delivered Intervention for Sleep Disturbance in Multiple Sclerosis N/A
Completed NCT03591809 - Combined Exercise Training in Patients With Multiple Sclerosis N/A
Completed NCT03594357 - Cognitive Functions in Patients With Multiple Sclerosis
Completed NCT03269175 - BENEFIT 15 Long-term Follow-up Study of the BENEFIT and BENEFIT Follow-up Studies Phase 4

External Links