4 completed, 4 unknown, 3 terminated. 4 Phase 1, 4 Phase 3, 3 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 4 | Terminated 2, Completed 1, Unknown 1 |
| Phase 3 | 4 | Unknown 2, Completed 1, Terminated 1 |
| Phase 2 | 3 | Completed 3 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-MD1003 in Healthy Male Subjects [14C]-MD1003 - Healthy Volunteers | Phase 1 | Completed | MedDay Pharmaceuticals SA | 6 | 2019-12-10 | 2020-11-02 |
| TQT2 Study to Evaluate the Effect of MD1003 on Cardiac Repolarization in Healthy Adult Subjects MD1003, Moxifloxacin 400mg, Placebo for MD1003 - Healthy Volunteers | Phase 1 | Unknown | MedDay Pharmaceuticals SA | 64 | 2019-11-11 | 2020-02-20 |
| HI Study to Assess and Compare the Pharmacokinetic Parameters of MD1003 in Hepatic Impaired Patients and Healthy Subjects MD1003 - Healthy Volunteers, Hepatic Impairment of Moderate Child Pugh Category | Phase 1 | Terminated | MedDay Pharmaceuticals SA | 15 | 2019-10-11 | 2020-05-13 |
| RI Study to Assess and Compare the Pharmacokinetic Parameters of MD1003 in Renal Impaired Patients and Healthy Subjects MD1003 - Healthy Volunteers, Impaired Renal Function | Phase 1 | Terminated | MedDay Pharmaceuticals SA | 24 | 2019-10-09 | 2020-05-13 |
| Evaluation of the Incidence of Relapses in Patients With Biotin-treated Progressive Multiple Sclerosis biotin, propensity score - Progressive Multiple Sclerosis | Unknown | University Hospital, Clermont-Ferrand | 3000 | 2018-05-30 | 2018-06-11 | |
| SERENDEM : MD1003 in Patients Suffering From Demyelinating Neuropathies, an Open Label Pilot Study MD1003 - Chronic Inflammatory Demyelinating Polyneuropathy, Peripheral Neuropathy | Phase 2 | Completed | MedDay Pharmaceuticals SA | 15 | 2016-12-05 | 2020-11-02 |
| Effect of MD1003 in Progressive Multiple Sclerosis (SPI2) MD1003 100mg capsule, PLACEBO - Multiple Sclerosis | Phase 3 | Terminated | MedDay Pharmaceuticals SA | 642 | 2016-12-01 | 2020-11-23 |
| Effect of MD1003 in Amyotrophic Lateral Sclerosis MD1003, Placebo oral capsule - ALS, Amyotrophic Lateral Sclerosis | Phase 2 | Completed | MedDay Pharmaceuticals SA | 30 | 2016-06-29 | 2019-06-04 |
| MD1003-AMN MD1003 in Adrenomyeloneuropathy MD1003 100 mg capsule, Placebo - Adrenomyeloneuropathy, Adrenoleukodystrophy | Phase 2 / Phase 3 | Completed | MedDay Pharmaceuticals SA | 67 | 2014-10-01 | 2017-10-09 |
| Effect of MD1003 in Spinal Progressive Multiple Sclerosis MD1003 100mg capsule, Placebo - Multiple Sclerosis | Phase 3 | Unknown | MedDay Pharmaceuticals SA | 144 | 2013-10-01 | 2017-03-27 |
| Effect of MD1003 in Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis MD1003 100mg capsule - Multiple Sclerosis | Phase 3 | Unknown | MedDay Pharmaceuticals SA | 105 | 2013-10-01 | 2017-03-27 |
Multiple Sclerosis (4) · Multiple Sclerosis, Chronic Progressive (3) · Adrenoleukodystrophy (1) · Amyotrophic Lateral Sclerosis (1) · Charcot-Marie-Tooth Disease (1) · Motor Neuron Disease (1) · Multiple Sclerosis, Relapsing-Remitting (1) · Optic Neuritis (1) · Peripheral Nervous System Diseases (1) · Polyradiculoneuropathy, Chronic Inflammatory Demyelinating (1) · Recurrence (1) · Renal Insufficiency (1) · Vision Disorders (1)
Biotin (6) · Moxifloxacin (1) · Propensity Score (1)
France (8) · United Kingdom (4) · Hungary (3) · Germany (2) · Spain (2) · Australia (1) · Belgium (1) · Canada (1) · Czechia (1) · Italy (1) · Poland (1) · Sweden (1) · Turkey (Türkiye) (1) · United States (1)
Ayman Tourbah, MD, PhD (2) · Frederic Sedel, MD (2) · Frederic Sedel, MD, PhD (2) · Yves Donazzolo, MD (2) · Bruce Cree, MD, PHD (1) · Frederic Sedel, MD, PHD (1) · Muna Albayaty, MD (1) · Patrick Aubourg, MD (1) · Somasekhara Menakuru, MS, MRCS (1)
PMID 29808469, PMID 32140672, PMID 33222767, PMID 37899433, PMID 42712237
2019 (2)