Ongoing Investigator-Initiated Studies

Ongoing Investigator-Initiated Studies

There are a number of investigator-initiated studies related to Mallinckrodt products in varying stages of completion. The following studies are listed on www.clinicaltrials.gov. Click on the links provided below to learn more.

H.P. Acthar Gel

A Pilot Study of Acthar as an Anti-Fibrotic Agent in Patients 1-Year Post Renal Transplantation

A Single Site, Investigator Initiated, Open Label, Observational Study on the Use of Acthar in Adult Onset Still's Disease

ACTH as a Re-Emerging Therapy for Uveitis (The ACTHAR Study)

ACTH as Treatment for Intractable Chronic Migraine

ACTH for Acute Treatment of Rheumatoid Arthritis Patients with Inadequate Response to Methotrexate

ACTH for Cutaneous Sarcoidosis Open Label Study

ACTH for Frequently Relapsing and Steroid Dependent Nephrotic Syndrome in Children

ACTH for Sarcoidosis-associated Calcium Dysregulation: Pilot Study

ACTH Treatment of APOL1-Associated Nephropathy

Acthar as Rescue Therapy for Transplant Glomerulopathy (TG) in Kidney Transplant Recipients

Acthar Dermatomyositis and Polymyosities Treatment (ADAPT Registry)

Acthar Effects on Myelination in Multiple Sclerosis Patients

Acthar Exposure and Outcomes Study in Adult Patients with Nephrotic Syndrome

Acthar for the Management of Treatment Resistant Nephrotic Syndrome in Children - A Pilot Study

Acthar in Rheumatoid Arthritis, Histologic and Functional Effect on Synovium

Acthar in the Treatment of Lupus Nephritis

Acthar Therapy for Severe CNS Sarcoidosis

Addition of Acthar to Treatment Regimen of Patients with Rheumatoid Arthritis Inadequately Controlled with Biologic Disease-Modifying Agents

Adrenocorticotropic Hormone (ACTH) for the Treatment of Sarcoid Uveitis

An Open Label, Multi-centered, Randomized Phase 2 Study to Evaluate the Safety, TolerabiLity and Bioactivity of Subcutaneous ACTH Gel in Patients with Scleritis: The ATLAS Study

An Open-Label Pilot Study of ACTH in the Treatment of IgA Nephropathy at High Risk of Progression

An Open-Label Randomized Phase IV Study of the Safety and Efficacy of Acthar in Patients with Membranous Lupus Nephritis

Analysis of Relapse in Multiple Sclerosis

Biomarkers to Characterize Subtypes of Neuroinflammation in Infantile Spasms and Responsiveness to ACTH

BRIGHT-MS Study: Utility of ADC Maps in Patients with Acute Demyelinating Lesions

Changes in Autoreactive Memory B Cells as Biomarker of Response to ACTH in Patients with Membranous Nephropathy

Clinical and Electroencephalographic Treatment and Outcome Biomarkers in ACTH Treated Patients with Infantile Spasms

Clinical Biomarkers of Disease Activity and Treatment Response in Patients with CNS Sarcoidosis Treated with ACTH Gel

Clinical Efficacy of Acthar in Severe Dry Eye Patients

Clinical Impact of Acthar in the Psoriatic Arthritis Patient

Cognitive Relapse in Multiple Sclerosis

Cytokine Profile Before and After Acthar Treatment for Chronic Sarcoidosis

Defining the Functional and Neuro-protective Potential of Acthar in Acute Optic Neuritis

Early Treatment of Infants at High Risk of Developing West Syndrome with Low-dose Adrenocorticotropin Hormone (ACTH)

Effect of ACTH on Interactions Between Antigen Presenting Cells and CD4 Tcells - Relapsing Remitting MS

Effect of ACTH on Measures of Fatigue in Patients with Relapsing Multiple Sclerosis

Effect of Acthar Therapy on Residual Renal Function in Dialysis Patients

Effects of Acthar on Advanced MRI Surrogate Markers of Disease Activity and on Comprehensive Immune Signature During MS Relapses

Efficacy Safety and Steroid Sparing Effect of ACTH in Patients with Hematologic Manifestations of SLE

Efficacy and Safety of Acthar for the Treatment of Refractory Cutaneous Manifestations of Dermatomyositis

Efficacy of Acthar in Recurrent Focal Segmental Glomerusclerosis after Kidney Transplant

Establishing a National Pediatric Glomerular Disease Learning Health System

Evaluations of the Patterns and Predictors of Corticosteroid Efficacy in the Management of Disease Flares in RA

Experience with H.P. Acthar® Gel for Treatment of Patients with Nephrotic Syndrome Due to Various Etiologies and Its Effects on Podocyte Function

Exploring the Immunoregulatory Functions of Melanocortins

Glomerularnephritis Biopsy Registry

Impact of Acthar on Proteinuria and Disease Progression in IgA Nephropathy Patients with Nephrotic Range Proteinuria

Mechanism of Action of Acthar Gel on Sarcoidosis Granulomas in a Novel Ex Vivo Model

Melanocortin Receptor Profiling in Dermatomyositis

MS Connect App: An Interactive Platform Connecting Physicians and Patients to Better Manage Multiple Sclerosis, Identify Relapses, and Improve Patient Quality of Life

Multicenter Trial of Acthar in the Treatment of Posttransplant Recurrent Focal Segmental Glomerulosclerosis

Multiple Sclerosis Relapse Patients Who Failed Recovery After High Dose IV Methylprednisolone

Neuroinflammation in Children with Infantile Spasms Measured with 11C-PK In11195 PET Response to ACTH

Ocular Sarcoidosis: Open Label Trial of Acthar Gel

Open-Label, Pilot Protocol of Patients with RA Who Were Treated with Acthar after an Incomplete Response to a Combination of DMARDs and Biologic DMARDs

Open Label Proof of Concept Study to Evaluate Efficacy and Safety of ACTH Gel in Refractory DM/PM

Open Label Prospective Study on the Efficacy of Repository Corticotropin (Acthar) in the Treatment of Non-infectious Retinal Vasculitis

Open Label Study to Evaluate Efficacy and Safety of Short-term Adjunctive Adrenocorticotropic Hormone (ACTH) Gel Therapy in Rheumatoid Arthritis

Phase 4 Trial of Neuroprotection with ACTH in Acute Optic Neuritis

Pilot Trial of ACTH 14 Days vs 5 Days Multiple Sclerosis Relapse

Practice Patterns and Outcomes of Acthar use in Children with Nephrotic Syndrome

Prospective Open Label Study of Acthar in Patients with Active Anterior Uveitis Who are Not Controlled with, or Intolerant to, Corticosteroids

Prospective Open Label Study of H.P. Acthar Gel Injection in Patients with Active Non-infectious Uveitis Who Have Associated Glaucoma Thus High Frequency Topical, Regional Corticosteroids and Oral Corticosteroids Cause Intolerable or Undesirable Side-effects

Registry for Advanced Sarcoidosis

Safety and Efficacy of Acthar Gel in Outpatient Dialysis Population

The Effect of ACTH with Methotrexate in Newly Diagnosed Rheumatoid Arthritis Patients from a Clinical and Structural Perspective as Measured by a CDAI Score

Tolerability of ACTH for Multiple Sclerosis Relapses

Treatment of Aggressive Forms of Multiple Sclerosis with Pulsed ACTH

Treatment of Chronic Antibody-Mediated Rejection in Kidney Transplant with Acthar

Use of ACTH in RA Related Flares

Use of Acthar in CKD Stage V or ESRD Patients in Preparation for a Kidney Transplant

Use of CXCL9 as a Biomarker of Acthar Efficacy

Utilizing Magnetoencephalography (MEG) to Improve Outcomes for Infantile Spasms

Whole Exome Sequencing and ACTH Responsiveness in Infantile Spasms

INOMAX

Dynamic Assessment Of Right Ventricular Function With Inhaled Nitric Oxide During Cardiac MRI

Effect Of Early Ino On Oxidative Stress, Vascular Tone, And Inflammation In Term And Late Preterm Infants With Hypoxic Respiratory Failure

Effect of Nitric Oxide on Therapeutic Potential of Umbilical Cord Derived Mesenchymal Stem Cells (UC-Mscs)

Effect of Nitric Oxide on Key Hox Transcription Factor Proteins During ELBW O2-Induced Lung Injury

Effects of Inhaled Nitric Oxide on Cerebral Blood Flow in Healthy Adults and Ischemic Stroke Patients

Efficacy Of Nitric Oxide Administration In Attenuating Ischemia/Reperfusion Injury During Neonatal Cardiopulmonary Bypass

Exercising Capacity and Gas Exchange in Adults with a History of Bronchopulmonary Dysplasia

Improvement in Acute Respiratory Parameters in Preterm Infants Under 34 Weeks Gestation after Initiation of INO in the Setting of Hypoxemic Respiratory Failure

Inhaled Nitric Oxide after Out-Of-Hospital Cardiac Arrest

Inhaled Nitric Oxide and Brain Outcomes after Pediatric Traumatic Brian Injury

Inhaled Nitric Oxide and Hypoxic Brain Injury in the Newborn

Inhaled Nitric Oxide And Neuroprotection In Premature Infants

Inhaled NO In Pulmonary Embolism, A Randomized, Double Blind, Placebo Controlled Study

Investigation Of The Effect Of Nitric Oxide On Ischemia Reperfusion Injury During Extended Donor Criteria Liver Transplantation

Potential Use Of Inhaled Nitric Oxide (Ino) As An Adjunct To Neonatal Resuscitation Protocol

OFIRMEV

Analgesic and Opioid-sparring Effects of IV APAP During Craniotomy

Analgesic Efficacy of IV Acetaminophen and the Post-Operative Consumption of Opiates in the Management of Acute Post-Operative Pain and Nausea after Laparoscopic Roux-en-Y Gastric Bypass (LRYGBP)

Comparison of Multimodal Analgesic Regimen with Intravenous Acetaminophen to Standard Oral Multimodal Therapy in Primary Total Hip Arthroplasty: A Randomized Controlled Double Blind Trial

Comparisons of Clinical, Pharmacological and Molecular Effects of Intravenous and Oral Acetaminophen in Adults with Sub Arachnoid Hemorrhage

Dexmedetomidine and IV acetaminophen For The Prevention Of Postoperative Delirium Following Cardiac Surgery In Adult Patients 60 Years Of Age And Older

Effect of Intravenous Acetaminophen on Postoperative Opioid-related Complications

Gastrointestinal Tract Recovery in Patients Undergoing Selected Surgical Procedures

IV Acetaminophen Use and Associated Outcomes in Neurocritical Care Patients with Fever

IV vs. Oral APAP as a Component of Multimodal Analgesia after Total Hip Arthroplasty: A Randomized, Blinded Controlled Trial

Pharmacoeconomics and Related Patient Outcomes of Multi-dose Intravenous Acetaminophen (OFIRMEV) in Patients Undergoing Robotic-assisted Laparoscopic Prostatectomy

Prospective, Double blind, Placebo control, Study of Acetaminophen IV on Hospital Length Of Stay in Morbidly Obese Individuals Undergoing Elective Laparoscopic Sleeve Gastrectomy

Randomized Control Trial of Intravenous Acetaminophen (OFIRMEV) for the Reduction of Intrapartum Maternal Fever and Fetal Tachycardia

Randomized, Double-Blind, Pilot Study on the Effect of Intravenous Multi-Dose Acetaminophen on Readiness for Discharge in Patients Undergoing Surgery with General Anesthesia

Role of Scheduled Intravenous Acetaminophen for Postoperative Pain Management in an Enhanced Recovery after Surgery Population

Single-Center, Randomized Clinical Trial to Study the Effectiveness of Intravenous Acetaminophen vs Oral Acetaminophen for Immediate Post-Operative Care in Posterolateral Lumbar Fusion

The Efficacy of Intravenous Acetaminophen during the Perioperative Period of Neurosurgical Patients Undergoing Craniotomies

The Opioid-Sparing and Analgesic Effects of IV Acetaminophen in Craniotomy: A Prospective, Randomized, Placebo-Controlled, Double-Blind Study

TERLIPRESSIN

Retrospective Data Review for Evaluation of Safety Profile of Terlipressin Usage in Single Centre Tertiary PICU in England

Terlipressin in the Treatment of Type-1 Hepatorenal Syndrome: Role of Inflammation in Disease Severity and Factors Associated with Response to Therapy

THERAKOS – U.S.

Effect of New Cellex Photopheresis System on the Cellular Immunity in CTCL Patients

Extracorporeal Photopheresis for the Management of Progressive Bronchiolitis Obliterans Syndrome in Medicare-Eligible Recipients of Lung Allografts

Mechanism of Action and Involvement of Tregs Differs in ECP-Treated CTCL and GvHD Patients

T-Regulatory Subsets as a Predictor of Response GvHD Treated with ECP

THERAKOS – EU

Exploratory Study of Biomarkers Associated with Clinical Response to ECP in the Treatment of aGvHD and cGvHD Post Allogeneic Hematopoietic Stem Cell Transplantation HSCT

Management of Acute and Chronic Graft-Versus-Host Disease with Extracorporeal Photopheresis (ECP). The Helsinki experience.

OL Prospective Study of Response to ECP and Role of Regulatory B Cells in cGvHD

Registry of the Therapeutic Impact and Quality of Life of Patients with Graft Versus Host Disease Undergoing Extracorporeal Photopheresis