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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002112-27 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MD1003 | Experimental | MD1003 100mg capsule, 1 capsule TID for 12 months |
|
| Placebo | Placebo Comparator | Placebo capsule, 1 capsule TID for 6 months, then switch to MD1003 100mg capsule, 1 capsule TID for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MD1003 100mg capsule | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual field mean deviation change from baseline | Visual field analyses are performed using the standard automated perimetry method | Baseline, 6 months, 12 months |
| Reappearance or improvement of the P00 wave on Visual Evoked Potential |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ayman Tourbah, MD, PhD | Hopital Maison Blanche | Principal Investigator |
| Frederic Sedel, MD, PhD | MedDay Pharmaceuticals SA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Pellegrin | Bordeaux | 33000 | France | |||
| Hopital de la cote de Nacre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29808469 | Derived | Tourbah A, Gout O, Vighetto A, Deburghgraeve V, Pelletier J, Papeix C, Lebrun-Frenay C, Labauge P, Brassat D, Toosy A, Laplaud DA, Outteryck O, Moreau T, Debouverie M, Clavelou P, Heinzlef O, De Seze J, Defer G, Sedel F, Arndt C. MD1003 (High-Dose Pharmaceutical-Grade Biotin) for the Treatment of Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis: A Randomized, Double-Blind, Placebo-Controlled Study. CNS Drugs. 2018 Jul;32(7):661-672. doi: 10.1007/s40263-018-0528-2. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 29, 2020 | |
| Reset | Nov 20, 2020 |
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Two parameters will be evaluated: (1) presence of a clear P100 wave, (2) P100 latency
| Baseline, 6 months, 12 months |
| Optical Coherence Tomography | Values of RNFL thickness and macular volume | Baseline, 6 months, 12 months |
| Caen |
| 14000 |
| France |
| Hopital Gabriel Montpied | Clermont-Ferrand | 63000 | France |
| Hopital general du Bocage | Dijon | 21000 | France |
| CHRU de Lille | Lille | 59000 | France |
| Hopital Pierre Wertheimer | Lyon | 69000 | France |
| Hopital de la Timone | Marseille | 13000 | France |
| Hopital Gui de Chauliac | Montpellier | 34000 | France |
| Hopital Central | Nancy | 54000 | France |
| Hopital Nord Laennec | Nantes | 44000 | France |
| Hopital Pasteur | Nice | 06000 | France |
| Centre hospitalier national d'ophtalmologie des Quinze Vingts | Paris | 75012 | France |
| Groupe hospitalier la Pitie-Salpetriere | Paris | 75013 | France |
| Fondation Rothschild | Paris | 75019 | France |
| Centre hospitalier Intercommunal Poissy/Saint-Germain-en-Laye | Poissy | 78300 | France |
| Hopital Maison Blanche | Reims | 51000 | France |
| Hopital Pontchaillou | Rennes | 35000 | France |
| Hopital de Hautepierre | Strasbourg | 67000 | France |
| Hopital Purpan | Toulouse | 31000 | France |
| UCL Institute of Neurology | London | WC1N 3BG | United Kingdom |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 29, 2020 | Nov 20, 2020 |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D009902 | Optic Neuritis |
| D014786 | Vision Disorders |
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D020528 | Multiple Sclerosis, Chronic Progressive |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D005128 | Eye Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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