11 completed, 3 terminated, 1 active not recruiting, 1 withdrawn. 6 Phase 2, 4 Phase 1, 3 Phase 3, 2 Not applicable, 1 Early Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 6 | Completed 4, Active not recruiting 1, Terminated 1 |
| Phase 1 | 4 | Completed 4 |
| Phase 3 | 3 | Completed 2, Withdrawn 1 |
| Not applicable | 2 | Completed 1, Terminated 1 |
| Early Phase 1 | 1 | Terminated 1 |
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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 |
|---|---|---|---|---|---|---|
| A Study of Chenodeoxycholic Acid (CDCA) in Newly Diagnosed Participants With Cerebrotendinous Xanthomatosis (CTX) Chenodeoxycholic acid, Chenodeoxycholic acid Placebo - Cerebrotendinous Xanthomatoses | Phase 3 | Withdrawn | Leadiant Biosciences, Inc. | 2024-05-27 | 2024-11-18 | |
| Multi-Center Study of ManNAc for GNE Myopathy ManNAc, Placebo - GNE Myopathy | Phase 2 | Active not recruiting | Leadiant Biosciences, Inc. | 54 | 2022-04-05 | 2025-06-13 |
| STP206 for the Prevention of Necrotizing Enterocolitis (NEC) STP206, Control - Necrotizing Enterocolitis | Phase 1 | Completed | Leadiant Biosciences, Inc. | 103 | 2014-01-30 | 2020-03-24 |
| EZN-2279 in Patients With ADA-SCID EZN-2279, Adagen - ADA-SCID, Adenosine Deaminase Deficiency | Phase 3 | Completed | Leadiant Biosciences, Inc. | 7 | 2014-01-24 | 2020-04-16 |
| Chemotherapy With Liposomal Cytarabine CNS Prophylaxis for Adult Acute Lymphoblastic Leukemia & Lymphoblastic Lymphoma DNR, VCR, PEG-asp - Acute Lymphocytic Leukemia, Adult Lymphoblastic Lymphoma | Phase 2 | Terminated | University of California, San Diego | 31 | 2014-01-01 | 2022-05-02 |
| A Pilot Study of Oncaspar® + Dexamethasone in Patients With Relapsed or Refractory T-Cell Lymphoma PEG-L-asparaginase, Dexamethasone acetate - T-Cell Lymphoma, Relapsed T-Cell Lymphoma | Early Phase 1 | Terminated | Dana-Farber Cancer Institute | 2 | 2013-07-01 | 2017-03-06 |
| Effect of Chronic Intranasal Oxytocin Administration on Sexual Function in Pre- and Postmenopausal Women Syntocinon Nasalspray, Placebo Nasalspray - Female Sexual Dysfunction | Phase 2 | Completed | Medical University of Vienna | 30 | 2012-06-01 | 2014-09-01 |
| Safety and Tolerability of STP206 in Healthy Adult Subjects STP206 or vehicle control - Healthy | Phase 1 | Completed | Leadiant Biosciences, Inc. | 24 | 2010-03-01 | 2013-05-17 |
| Confocal Endomicroscopy for Biliary Strictures -Phase I ERCP and Confocal imaging - Biliary Stricture | Not applicable | Terminated | Mayo Clinic | 12 | 2009-04-01 | 2012-02-24 |
| Methotrexate, Vincristine, Pegylated L-Asparaginase and Dexamethasone (MOAD) in Acute Lymphoblastic Leukemia (ALL) Salvage Methotrexate, Vincristine, PEG-l-asparaginase - Leukemia, Lymphocytic, Acute | Phase 2 | Completed | M.D. Anderson Cancer Center | 37 | 2009-03-01 | 2015-06-29 |
| Acetyl-L-Carnitine in Type 2 Diabetes acetyl-L-carnitine/statin (simvastatin), placebo - Diabetes Type 2, Hypertension | Phase 3 | Completed | Mario Negri Institute for Pharmacological Research | 229 | 2008-04-01 | 2013-02-25 |
| CARNIVAL Type I: Valproic Acid and Carnitine in Infants With Spinal Muscular Atrophy (SMA) Type I Valproic Acid and Levocarnitine - Spinal Muscular Atrophy Type I | Phase 1 / Phase 2 | Completed | University of Utah | 40 | 2008-04-01 | 2015-06-15 |
| Valproic Acid and Carnitine in Patients With Spinal Muscular Atrophy Valproic Acid and Levocarnitine, Placebo - Spinal Muscular Atrophy | Phase 2 | Completed | University of Utah | 94 | 2005-09-01 | 2025-03-19 |
| Carnitine Levels and Carnitine Supplementation in Type I Diabetes Carnitine (drug) - Diabetes Mellitus, Type I, Hypoglycemia | Completed | Children's Mercy Hospital Kansas City | 200 | 2004-10-01 | 2012-02-28 | |
| Study of Safety and Dosing Effect on SMN Levels of Valproic Acid (VPA) in Patients With Spinal Muscular Atrophy Valproic Acid - Spinal Muscular Atrophy | Phase 1 | Completed | University of Utah | 42 | 2003-09-01 | 2023-05-10 |
| Randomized Study of New Formulation Ophthalmic Cysteamine Hydrochloride for Corneal Cystine Accumulation in Patients With Cystinosis cysteamine hydrochloride - Cystinosis | Not applicable | Completed | FDA Office of Orphan Products Development | 30 | 1999-12-01 | 2015-03-25 |
Muscular Atrophy, Spinal (3) · Precursor Cell Lymphoblastic Leukemia-Lymphoma (2) · Cholangiocarcinoma (1) · Cystinosis (1) · Diabetes Mellitus, Type 1 (1) · Diabetes Mellitus, Type 2 (1) · Distal myopathy, Nonaka type (1) · Enterocolitis, Necrotizing (1) · Hypertension (1) · Hypoglycemia (1) · Leukemia (1) · Lymphoma, T-Cell (1) · Rare Diseases (1) · Severe Combined Immunodeficiency (1) · Severe combined immunodeficiency due to adenosine deaminase deficiency (1)
Carnitine (3) · Valproic Acid (3) · pegaspargase (3) · Methotrexate (2) · Rituximab (2) · Vincristine (2) · Acetylcarnitine (1) · Calcium Dobesilate (1) · Chenodeoxycholic Acid (1) · Cholangiopancreatography, Endoscopic Retrograde (1) · Cyclophosphamide (1) · Cysteamine (1) · Cytarabine (1) · Dasatinib (1) · Daunorubicin (1)
United States (12) · Canada (2) · Austria (1) · Germany (1) · Israel (1) · Italy (1)
Anthony A. Amato, MD (1) · Edward F. Lemanowicz (1) · Elie Haddad, MD, PhD (1) · Francis Rossignol, MD (1) · Gautam Borthakur, M.D. (1) · James K Mangan, MD, PhD (1) · Kathryn J Swoboda, M.D (1) · Kathryn J Swoboda, M.D. (1) · Kathryn Swoboda, M.D. (1) · Larry K Midyett, MD (1) · Michael B. Wallace, M.D. (1) · Michael S Caplan, MD (1) · Phillippe Armand, MD (1) · Piero Ruggenenti, MD (1) · Sandra P Reyna, M.D. (1)
PMID 12011123, PMID 19440247, PMID 20808854, PMID 21754985, PMID 26151620, PMID 28189292
2023 (1), U01AR070498 (1)