PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT04776239: Allogeneic Mesenchymal Human Stem Cell Infusion Therapy for Endothelial DySfunctiOn in Diabetic Subjects With Symptomatic Ischemic Heart Disease. (ACESO-IHD)
Official title: Allogeneic Mesenchymal Human Stem Cell Infusion Therapy for Endothelial DySfunctiOn in Diabetic Subjects With Symptomatic Ischemic Heart Disease.
Conditions: Diabetes Mellitus
Ischemic Heart Disease
Summary: The purpose of this study is to test the hypothesis that allogeneic Mesenchymal Stem Cells (MSCs) promote systemic and coronary endothelial repair through rescue of bone marrow progenitors in type 2 diabetic patients with symptomatic IHD compared to placebo.
Interventions:
description: 1 single intravenous infusion
name: 100 million Allogeneic Mesenchymal Human Stem Cells
other_name: allo-human Mesenchymal Stem Cells (hMSCs)
stem cells
type: Drug
description: Placebo delivered via peripheral intravenous infusion
name: Placebo
type: Other
Study arms:
design_group_description: Participants in this group will be receive a single administration of intravenous allogeneic human Mesenchymal Stem Cells (hMSCs) (100 million).
design_group_title: Group A: Allogeneic Mesenchymal Stem Cells (MSCs) Group
design_group_type: Experimental
design_group_description: Participants in this group will receive a single dose of placebo (Cell-free PlasmaLyte-A medium supplemented with 1% HSA) infusion.
design_group_title: Group 2: Placebo Group
design_group_type: Experimental
Sponsor: University of Miami
Collaborators: National Heart, Lung & Blood Institute
Drug name mappings:
name: Allogeneic human mesenchymal stem cells(University of Miami)
lang: EN
Clinical trial NCT07502768: Tislelizumab Plus Zeprumetostat for Relapsed or Refractory NK/T-Cell Lymphoma
Official title: A Multicenter, Open-Label, Seamless Phase Ib/II Study Evaluating the Safety and Efficacy of Tislelizumab in Combination With Zeprumetostat (SHR2554) in Patients With Relapsed or Refractory NK/T-Cell Lymphoma
Conditions: Extranodal NK/T-cell Lymphoma
NK/T-cell Lymphoma
Relapsed or Refractory NK/T-Cell Lymphoma
Summary: This is a multicenter, open-label, phase Ib/II study evaluating tislelizumab in combination with zeprumetostat (SHR2554) in patients with relapsed or refractory NK/T-cell lymphoma after at least one prior asparaginase-based chemotherapy-containing regimen, with or without radiotherapy. In phase Ib, two fixed dose levels of zeprumetostat in combination with tislelizumab will be evaluated to determine the recommended phase II dose (RP2D). In phase II, patients will be enrolled into 2 predefined cohorts according to prior exposure to PD-1 inhibitors to further evaluate efficacy and safety. The primary phase II endpoint is objective response rate at week 12 assessed by independent blinded imaging review according to Lugano 2014 criteria.
Interventions:
description: Tislelizumab 200 mg administered intravenously on day 1 of each 21-day cycle.
name: Tislelizumab
type: Drug
description: Zeprumetostat (SHR2554), an oral EZH2 inhibitor, administered twice daily. In phase Ib, dose levels are 300 mg BID and 350 mg BID. In phase II, zeprumetostat is administered at the recommended phase II dose selected from phase Ib.
name: Zeprumetostat
type: Drug
Study arms:
design_group_description: Tislelizumab 200 mg IV every 3 weeks plus zeprumetostat 300 mg orally twice daily.
design_group_title: Phase Ib Dose Level A
design_group_type: Experimental
design_group_description: Tislelizumab 200 mg IV every 3 weeks plus zeprumetostat 350 mg orally twice daily.
design_group_title: Phase Ib Dose Level B
design_group_type: Experimental
design_group_description: Tislelizumab 200 mg IV every 3 weeks plus zeprumetostat at the RP2D in patients previously exposed or refractory to PD-1 inhibitor therapy.
design_group_title: Phase II Cohort-R (Prior PD-1 Exposed/Refractory)
design_group_type: Experimental
design_group_description: Tislelizumab 200 mg IV every 3 weeks plus zeprumetostat at the RP2D in patients without prior PD-1 inhibitor therapy.
design_group_title: Phase II Cohort-N (PD-1 Inhibitor-Naive)
design_group_type: Experimental
Sponsor: Fudan University
Collaborators: Fudan University
Drug name mappings:
name: 替雷利珠单抗
lang: CN
name: Tislelizumab
lang: EN
name: チスレリズマブ（遺伝子組換え）（JAN）
lang: JP
name: 泽美妥司他
lang: CN
name: Zeprumetostat
lang: EN
Clinical trial NCT00852124: Safety of VSL#3 in Adult Asthmatics
Official title: Safety of VSL#3 for Adult Asthmatics
Conditions: Asthma
Summary: We are proposing to test the safety of the probiotic, VSL#3, in a placebo controlled double blind safety study in 30 asthmatic adults. This adult safety trial was requested by the FDA IND review of a pediatric asthma protocol.
Adults with a doctor diagnosis of persistent asthma will take VSL#3 or placebo twice daily for 3 months. Data will be collected, including age, race, height, and weight, present medications, past medical history with emphasis on signs/symptoms of asthma.
On visits to the clinic we will evaluate
* Changes in lung function
* Intestinal permeability
* Intestinal bacteria
* Levels of inflammation in the blood
* Women will have repeat urine pregnancy testing at each clinic visit
Interventions:
description: VSL#3 2 times daily
name: VSL#3
type: Biological
description: 1 packet 2 x daily of placebo
name: VSL#3 or placebo
type: Biological
Study arms:
design_group_description: Packets similar to VSL#3 will be taken 2 X daily but not containing active bacteria
design_group_title: Placebo
design_group_type: Placebo Comparator
design_group_description: Packets of VSL#3 (powder containing 8 bacteria believed to be beneficial) will be taken 2 x daily in food or a cool beverage.
design_group_title: VSL#3
design_group_type: Active Comparator
Sponsor: University of Maryland Baltimore
Collaborators: National Center For Complementary & Integrative Health
Drug name mappings:
name: Live lactic acid bacteria probiotics(Vsl Pharmaceuticals, Inc.)
lang: EN
Clinical trial NCT04713488: An Open Study on the Safety, Tolerability, and Immunogenicity of "Sputnik Light" Vaccine
Official title: An Open Study on the Safety, Tolerability, and Immunogenicity of "Sputnik Light" t Vaccine for Prevention of Coronavirus Infection Caused by the SARS-CoV-2 Viruso
Conditions: COVID-19 Prevention
Summary: Phase I-II open prospective, two-stage, non-randomized study in healthy volunteers.
Interventions:
description: solution for intramuscular injection Composition for 1 dose (0.5 ml)
name: Sputnik Light
other_name: vector vaccine to help prevent the SARS-CoV-2-induced coronavirus infection
type: Biological
Study arms:
design_group_description: solution for intramuscular injection Composition for 1 dose (0.5 ml): Active substance: recombinant serotype 26 adenoviral particles containing the SARS-CoV-2 S protein gene, in the amount of (1.0±0.5) x 10*11 particles per dose.
design_group_title: Sputnik Light Vaccine
design_group_type: Experimental
Sponsor: Gamaleya Research Institute Of Epidemiology And Microbiology, Health Ministry Of The Russian Federation
Collaborators: Russian Direct Investment Fund
Drug name mappings:
name: Gam-COVID-Vac
lang: EN
Clinical trial NCT01083667: SOD1 Inhibition by Pyrimethamine in Familial Amyotrophic Lateral Sclerosis (ALS)
Official title: Phase I/II Study of SOD1 Inhibition by Pyrimethamine in Familial ALS
Conditions: Familial Amyotrophic Lateral Sclerosis
Summary: The objective of this study will be to evaluate the safety, tolerability and effect on SOD1 levels by pyrimethamine in patients with familial amyotrophic lateral sclerosis.
Interventions:
description: Open Label, dose escalating,
name: Pyrimethamine
other_name: Daraprim
type: Drug
Study arms:
design_group_description: Open label. Only one arm will receive the intervention.
design_group_title: Pyrimethamine
design_group_type: Experimental
Sponsor: Weill Medical College of Cornell University
Collaborators: Muscular Dystrophy Association, Inc.
Drug name mappings:
name: 乙胺嘧啶
lang: CN
name: Pyrimethamine
lang: EN
Clinical trial NCT05905120: Assessing Dopamine Transporter Occupancy in the Healthy Adult Brain With Toludivenlafaxine Hydrochloride Extended-Release Tablets Using 11C-CFT Positron Emission Tomography (PET)
Official title: A Single-Arm, Non-Randomized, Open-Label, Exploratory Mechanistic Validation (PoM) Clinical Trial of Toludivenlafaxine Hydrochloride Extended-Release Tablets Assessing Dopamine Transporter Occupancy in the Healthy Adult Brain Using 11C-CFT Positron Emission Tomography (PET)
Conditions: Major Depressive Disorder
Summary: This study was a single-arm, non-randomized, open-label clinical study to assess dopamine transporter occupancy in the brain of healthy adults using 11C-CFT positron emission tomography (PET)
Interventions:
description: 80 mg/tablet, 2 tablets each time, once a day, for 4 days, orally at 30 min after the start of meals, 200 mL water to take
name: Toludivenlafaxine hydrochloride sustained-release tablets
type: Drug
Study arms:
design_group_description: 80 mg/tablet, 2 tablets each time, once a day, for 4 days
design_group_title: Toludivenlafaxine hydrochloride sustained-release tablets
design_group_type: Experimental
Sponsor: Shanghai Mental Health Center
Collaborators: Yantai University
Drug name mappings:
name: 盐酸托鲁地文拉法辛
lang: CN
name: Toludesvenlafaxine Hydrochlorid
lang: EN
Clinical trial NCT00005807: Treating Patients With Advanced Solid Tumors, Breast Cancer or Recurrent Ovarian Cancer
Official title: A Phase I Scientific Exploratory Study of Epothilone B Analog in Patients With Solid Tumors and Gynecological Malignancies
Conditions: Breast Cancer
Ovarian Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of BMS-247550 in treating patients who have metastatic, recurrent, or locally advanced, ovarian cancer, breast cancer, or metastatic or unresectable solid tumors.
Interventions:
description: anticancer agent for the treatment of patients with malignant tumors.
name: BMS-247550
other_name: epothilone derivative
type: Drug
Study arms:
design_group_description: dose escalation treatment
design_group_title: Treated Participants
design_group_type: Experimental
Sponsor: Albert Einstein College of Medicine, Inc.
Collaborators: National Cancer Institute
Drug name mappings:
name: 伊沙匹隆
lang: CN
name: Ixabepilone
lang: EN
Clinical trial NCT07215923: A First in Human Single Ascending Dose (SAD) Study of ATI-1013 in Healthy Smokers
Official title: A First in Human, Double-Blind, Placebo-Controlled, Randomized Evaluation of Single Ascending Doses of ATI-1013, a Human Monoclonal Antibody to Nicotine in Healthy Smokers
Conditions: Thromboangiitis Obliterans (Buerger's Disease)
Summary: This study is a first-in-human clinical trial of drug ATI-1013, in healthy adult cigarette smokers. The main questions it aims to answer are to learn about the safety of drug ATI-1013, how long drug ATI-1013 remains within the body, does drug ATI-1013 trigger an immune response, and the effects of drug ATI-1013 on nicotine levels within the body.
The clinical trial will compare drug ATI-1013 to a placebo (a look-alike substance that contains no drug) to see if drug ATI-1013 has comparable safety.
Participants will have a Screening visit (Day -28 to -3) and will be admitted on Day -2. Each participant will receive one intravenous (IV) infusion of ATI-1013 or placebo (Day 1). Participants will remain in-clinic for at least 48 hours post-dose and return for follow-up visits on Days 7, 21, 42, 56, and 84, with telephone check-ins on Days 5, 14, 28, and 70. Participants will keep a diary of their cigarette use and smoking behaviors.
Interventions:
description: Single intravenous (IV) infusion of ATI-1013, 0.2 g total dose.
name: ATI-1013 (0.2 g)
type: Biological
description: Single IV infusion of ATI-1013, 0.8 g total dose.
name: ATI-1013 (0.8 g)
type: Biological
description: Single IV infusion of ATI-1013, 3.2 g total dose.
name: ATI-1013 (3.2 g)
type: Biological
description: Matching placebo (vehicle) IV infusion.
name: Placebo
type: Other
Study arms:
design_group_description: Single-ascending-dose Cohort 1. Participants receive a single intravenous (IV) infusion of ATI-1013 0.2 g on Day 1. Randomization within the cohort is 4:1 (ATI-1013:placebo).
design_group_title: ATI-1013 (0.2 g)
design_group_type: Experimental
design_group_description: Single-ascending-dose Cohort 2. Participants receive a single IV infusion of ATI-1013 0.8 g on Day 1. Randomization 4:1 (ATI-1013:placebo).
design_group_title: ATI-1013 (0.8 g)
design_group_type: Experimental
design_group_description: Single-ascending-dose Cohort 3. Participants receive a single IV infusion of ATI-1013 3.2 g on Day 1. Randomization 4:1 (ATI-1013:placebo).
design_group_title: ATI-1013 (3.2 g)
design_group_type: Experimental
Sponsor: Antidote Therapeutics, Inc.
Collaborators: National Institute on Drug Abuse
National Institutes of Health
Drug name mappings:
name: ATI-1013
lang: EN
Clinical trial NCT04314206: VNRX-5024 Safety and PK in Healthy Adult Volunteers
Official title: A Randomized, Double-Blind, Placebo-Controlled, Sequential Group, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of Single and Repeat Doses of VNRX-5024 Administered Orally for 10 Days in Healthy Adult Volunteers
Conditions: Healthy Subjects
Summary: This is a 2-part dose-ranging study to evaluate the safety and pharmacokinetics of escalating doses of VNRX-5024. Subjects will be enrolled in one of three dose cohorts. They will receive a single dose on Day 1 in Part 1 and will proceed into the multiple dose Part 2 of the study after safety assessments and PK samples are collected. In the multiple dose part of the study, subjects will receive multiple doses of VNRX-5024 for 10 days.
Interventions:
description: Part 1: one dose<br/>Part 2:<br/>Cohort 1: 10 doses (once a day for 10 days) Cohort 2: 19 doses (once every 12 hours [q12h] dosing for 9 days with a single morning dose on Day 10) Cohort 3: 28 doses (once every 8 hours [q8h] dosing for 9 days with a single morning dose on Day 10)
name: VNRX-5024
type: Drug
description: Part 1: one dose<br/>Part 2:<br/>Cohort 1: 10 doses (once a day for 10 days) Cohort 2: 19 doses (once every 12 hours [q12h] dosing for 9 days with a single morning dose on Day 10) Cohort 3: 28 doses (once every 8 hours [q8h] dosing for 9 days with a single morning dose on Day 10)
name: Placebo for VNRX-5024
type: Drug
Study arms:
design_group_description: Capsule formulation
design_group_title: VNRX-5024
design_group_type: Experimental
design_group_description: Placebo for VNRX-5024
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: Basilea Pharmaceutica AG
Collaborators: National Institute of Allergy & Infectious Diseases
Drug name mappings:
name: VNRX-5024
lang: EN
Clinical trial NCT01036893: M0001 Effects on Oral Contraceptive Plasma Levels
Official title: The Effect of Prucalopride on the Plasma Levels of Oral Contraceptives (Ethinylestradiol and Norethisterone) in Healthy Subjects
Conditions: Healthy Volunteers
Summary: This is a randomized, open-label, two-way cross-over drug-drug interaction Phase I trial.
The objectives of this phase I trial are to investigate in healthy female subjects:
* the effect of prucalopride on the absorption of ethinylestradiol and norethisterone acetate, the active constituents of several oral contraceptives, after the first dose of prucalopride.
* the effect of multiple oral dosing of 2 mg prucalopride, for 6 days o.d. (steady state), on the pharmacokinetics of ethinylestradiol and norethisterone acetate.
This trial will be conducted in healthy females of child bearing potential, i.e. females aged between 18 and 45 years (pre-menopausal).
Interventions:
description: prucalopride 2 mg oral dosing o.d. for 6 days
name: prucalopride
type: Drug
Study arms:
design_group_title: oral contraceptives without prucalopride
design_group_type: No Intervention
design_group_description: prucalopride
design_group_title: oral contraceptives with prucalopride
design_group_type: Active Comparator
Sponsor: Movetis NV
Collaborators: FOCUS GmbH
Drug name mappings:
name: 琥珀酸普芦卡必利
lang: CN
name: Prucalopride Succinate
lang: EN
Clinical trial NCT05440942: Combined MEK, STAT3 and PD-1 Inhibition in Metastatic Pancreatic Ductal Adenocarcinoma
Official title: A Phase 1 Trial of Combined MEK, STAT3 and PD-1 Inhibition in Metastatic Pancreatic Ductal Adenocarcinoma
Conditions: Pancreatic Ductal Adenocarcinoma
Summary: The purpose of this research is to test whether a combination treatment of Trametinib, Retifanlimab, and Ruxolitinib (TR^2) will reduce tumor size in patients with metastatic pancreatic ductal adenocarcinoma (PDAC).
Interventions:
description: Trametinib will be administered orally once daily via tablet.
name: Trametinib
other_name: GSK1120212
Mekinist
TMT212-NXA
type: Drug
description: Ruxolitinib will be administered orally twice daily (BID) via tablet.
name: Ruxolitinib
other_name: INC424
INCB018424
type: Drug
description: Retifanlimab will be administered intravenously (IV) on Day 8 of a 28-day cycle..
name: Retifanlimab
other_name: INCMGA00012
type: Drug
Study arms:
design_group_description: Participants in this group will receive Trametinib, Ruxolitinib and Retifanlimab in a dose escalation/de-escalation design to determine the maximum tolerated dose (MTD). Participants will receive Trametinib and Ruxolitinib for two weeks on (Days 1-14) and two weeks off (Days 15-28) and Retifanlimab on Day 8 of a 28-day cycle. Doses will be administered as follows:<br/>* Dose Level -1A: Trametinib 1 mg orally (PO), Ruxolitinib 5 mg PO, Retifanlimab 500 mg intravenously (IV);<br/>* Starting Dose Level 1A: Trametinib 1.5 mg PO, Ruxolitinib 10 mg PO, Retifanlimab 500 mg IV;<br/>* Dose Level 2A: Trametinib 2 mg PO, Ruxolitinib 10 mg PO, Retifanlimab 500 mg IV;<br/>* Dose Level 3A: Trametinib 2 mg PO, Ruxolitinib 15 mg PO, Retifanlimab 500 mg IV.
design_group_title: Part 1 Schedule A: TR^2 Dose Escalation/De-Escalation
design_group_type: Experimental
design_group_description: Participants in this group will receive the MTD determined in Part 1 Schedule A on a continuous dosing cycle: Trametinib and Ruxolitinib on Days 1-28 and Retifanlimab on Day 8 of a 28-Day Cycle.
design_group_title: Part 1 Schedule B: TR^2 Alternate Schedule
design_group_type: Experimental
design_group_description: Participants in this group will receive Trametinib, Ruxolitinib and Retifanlimab at the most appropriate dose and schedule determined in Part 1. Participants will continue to receive treatment as long as receiving clinical benefit or until disease progression.
design_group_title: Part 2: TR^2 Expansion Cohort
design_group_type: Experimental
Sponsor: University of Miami
Collaborators: Novartis Pharmaceuticals Corp.
Incyte Corp.
University of Miami
Drug name mappings:
name: 二甲基亚砜曲美替尼
lang: CN
name: Trametinib dimethyl sulfoxide
lang: EN
name: トラメチニブ ジメチルスルホキシド付加物
lang: JP
name: 磷酸芦可替尼
lang: CN
name: Ruxolitinib  Phosphate
lang: EN
name: ルキソリチニブリン酸塩
lang: JP
name: 瑞弗利单抗
lang: CN
name: Retifanlimab
lang: EN
name: レチファンリマブ（遺伝子組換え）
lang: JP
Clinical trial NCT00562250: Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy Subjects
Official title: Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy Subjects
Conditions: Diabetes Mellitus, Type 2
Summary: The purpose of the study is to determine the effect of glimepiride on dapagliflozin and the effect of dapagliflozin on glimepiride in healthy volunteers. In addition, the safety and tolerability of dapagliflozin with be assessed alone and while taking glimepiride
Interventions:
description: Tablets, Oral, 20 mg, once daily, single dose
name: Dapagliflozin
type: Drug
description: Tablets, Oral, 4 mg, once daily, single dose
name: Glimepiride
type: Drug
description: Tablets, Oral, Dapagliflozin 20 mg + Glimepiride 4 mg, once daily, single dose
name: Dapagliflozin + Glimepiride
type: Drug
Study arms:
design_group_title: Arm 1
design_group_type: Experimental
design_group_title: Arm 2
design_group_type: Active Comparator
design_group_title: Arm 3
design_group_type: Active Comparator
Sponsor: AstraZeneca PLC
Collaborators: Bristol Myers Squibb Co.
Drug name mappings:
name: 达格列净
lang: CN
name: Dapagliflozin
lang: EN
name: ダパグリフロジンプロピレングリコール水和物
lang: JP
Clinical trial NCT07424222: Ruxolitinib for Immune Effector Cell Associated Hemophagocytic Lymphohistiocytosis-like Syndrome (RISE)
Official title: Ruxolitinib for Immune Effector Cell Associated Hemophagocytic Lymphohistiocytosis-like Syndrome (RISE)
Conditions: Immune Effector Associated Hemophagocytic Lymphohistiocytosis-like Syndrome (IEC-HS)
Summary: This is a pilot study to gather information about safety and efficacy of using ruxolitinib (RUX) to treat Immune Effector Cell Associated Hemophagocytic Lymphohistiocytosis-like Syndrome (IEC-HS) occurring after CAR-T therapy. In addition, correlative studies will be done to 1) estimate the optimal duration of RUX therapy, 2) to identify immunological biomarkers associated with response (3) To evaluate the dynamics of CAR T expansion following RUX treatment.
Oral RUX will be administered twice daily, with dosing determined by the participant's baseline platelet count. Treatment will continue for up to 8 weeks unless significant adverse events occur or the treating physician concludes that the therapy is no longer providing clinical benefit.
The study expects to accrue 16 evaluable patients diagnosed with IEC-HS over 2 years.
Interventions:
description: In this study, Ruxolitinib will be supplied as 5 mg tablets which will be administered orally twice daily (BID) as an open-label, investigational product.<br/>Ruxolitinib dosing based on platelet numbers:<br/>* 5 mg twice a day if platelets are under 30,000/µL,<br/>* 10 mg twice a day if platelets are more than or equal to 30,000/µL but less than 50,000/µL, or<br/>* 15 mg twice a day if platelets are more than or equal to 50,000/µL<br/>Patients who respond may continue treatment for at least 8 weeks. Therapy will be discontinued for significant toxicity or evidence of IEC-HS progression. After 8 weeks, the dose may be tapered as clinically appropriate, with continued therapy permitted for up to 6 additional months if clinical benefit persists.
name: Ruxolitinib
other_name: JAKAFI
type: Drug
Study arms:
design_group_description: Patients will receive ruxolitinib at a dose of 5 mg twice a day if platelets are under 30,000/µL, ruxolitinib 10 mg twice a day if platelets are ≥30,000/µL but under 50,000/µL, or ruxolitinib 15 mg twice a day if platelets are ≥50,000/µL at the start of treatment.<br/>If a favorable response to ruxolitinib is noted (as defined in the protocol), patients will continue on treatment for at least 8 weeks if it is tolerated without significant side effects.
design_group_title: Ruxolitinib (RUX) therapy
design_group_type: Experimental
Sponsor: The Sidney Kimmel Comprehensive Cancer Center
Collaborators: Incyte Corp.
Drug name mappings:
name: 磷酸芦可替尼
lang: CN
name: Ruxolitinib  Phosphate
lang: EN
name: ルキソリチニブリン酸塩
lang: JP
Clinical trial NCT04204889: Trial of Oxaloacetate in ALS
Official title: Trial of Oxaloacetate in Amyotrophic Lateral Sclerosis
Conditions: ALS
Summary: The purpose of this study is to determine the safety and the maximal tolerated dose of Oxaloacetate (OAA) in patients with Amyotrophic Lateral Sclerosis (ALS).
Interventions:
description: The first 3 patients will receive 500 mg twice daily, and subsequent cohorts will increase by 500 mg per dose to a maximum of 2500 mg twice daily.
name: Oxaloacetic Acid
other_name: Oxaloacetate
type: Drug
Study arms:
design_group_description: 3+3 dose escalating trial starting with 500mg twice daily orally and ending with 2500mg twice daily.
design_group_title: Oxaloacetate
design_group_type: Experimental
Sponsor: University of Kansas Medical Center
Collaborators: Terra Biological LLC
Drug name mappings:
name: Oxaloacetic Acid
lang: EN