Clinical trials: enrolling by invitation
OsteoFlo HydroFiber
OsteoFlo HydroFiber Ambispective Evaluation
The goal of this observational, ambispective study is to collect real world patient outcomes to characterize the safety and effectiveness of OsteoFlo HydroFiber when used to promote fusion in the lumbar spine.
- Trial name
- NCT07784673
- Testing
- OsteoFlo HydroFiber
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- SurGenTec LLC
Subjects Treated With NMP as Part of Their Spine Surgery, Degenerative Disc Disease (DDD)
INDUCE: A Prospective 2-Year Spine Registry
The primary objective of this prospective, observational registry study is to evaluate the safety and effectiveness of Natural Matrix Protein® (NMP®) when used to promote fusion in the cervical or lumbar spine.
- Trial name
- NCT06971835
- Testing
- NMP
- Where
- 3 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Red Rock Regeneration Inc.
Type 2 Diabetes Mellitus, Type2diabetes
Continued Access to the Endogenex System for Participants in the ReCET Pivotal Study
This study is designed to collect real-world data on the safety and performance of the Endogenex System in the cohort of participants who were originally randomized to the sham control arm of the ReCET Study.
- Conditions
- Type 2 Diabetes Mellitus, Type2diabetes, Diabetes Mellitus, Type 2, Type 2 Diabetes
- Trial name
- NCT07197788
- Testing
- Endogenex System
- Where
- 11 sites in United States, Australia
- Volunteers
- 50 people
- Sponsor
- Endogenex, Inc.
Immunoglobulin A Nephropathy
A Phase 3 Open-Label Study of Long-term Treatment With Povetacicept in Adults With Immunoglobulin A Nephropathy
The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of povetacicept in participants with immunoglobulin A nephropathy (IgAN).
- Trial name
- NCT07807995
- Testing
- Povetacicept
- Where
- 4 sites in United States
- Volunteers
- 605 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Substance Use Disorder (SUD)
Research and Engagement on Substance Use: Harnessing Awareness and Personalized Education (RESHAPE) to Improve Well-being and Self-efficacy
The goal of the RESHAPE study is to learn about the needs and experiences of adults who report having, or being at risk for, substance use disorder.
- Trial name
- RESHAPE (NCT06952491)
- Where
- United States
- Volunteers
- 1,910 people
- Sponsor
- Evidation Health
AML (Acute Myelogenous Leukemia), MDS (Myelodysplastic Syndrome)
Forecasting Relapse Outcomes With AlloHeme-based Risk Detection in Post-Allo-HCT AML/MDS Patients (FORWARD)
AlloHeme is a blood-based monitoring test developed by the CareDx laboratory that utilizes NGS technology coupled with a proprietary algorithm to predict the likelihood of a relapse in post-allo-HCT AML/MDS patients.
- Conditions
- AML (Acute Myelogenous Leukemia), MDS (Myelodysplastic Syndrome), CMML
- Trial name
- FORWARD (NCT07607327)
- Testing
- AlloHeme
- Where
- 3 sites in United States
- Volunteers
- 400 people
- Sponsor
- CareDx
Heart Diseases, Heart Failure
Global Utilization And Registry Database for Improved heArt preservatioN
The primary objective of this study is to collect real-world clinical performance data to assess the clinical outcomes of patients receiving heart transplants using donor hearts transported via the SherpaPak CTS System.
- Conditions
- Heart Diseases, Heart Failure, Heart Defects, Congenital
- Trial name
- GUARDIAN (NCT04141605)
- Testing
- SherpaPak Cardiac Transport System
- Where
- 22 sites in United States, Austria and 2 more
- Volunteers
- 4,000 people
- Sponsor
- Paragonix Technologies
Myositis, Active Idiopathic Inflammatory Myopathy
A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy
The main purpose of this study is to measure the long-term safety and tolerability of efgartigimod PH20 SC in adult participants with Idiopathic Inflammatory Myopathy (IIM) who previously participated in ARGX-113-2007.
- Conditions
- Myositis, Active Idiopathic Inflammatory Myopathy, Dermatomyositis, Polymyositis
- Trial name
- ALKIVIA+ (NCT05979441)
- Testing
- Efgartigimod PH20 SC
- Where
- 92 sites in United States, Argentina and 27 more
- Volunteers
- 240 people
- Sponsor
- argenx
Systemic Lupus Erythematosus
A Study to Evaluate the Safety and Tolerability of Dapirolizumab Pegol in Study Participants With Systemic Lupus Erythematosus
The purpose of this study is to evaluate long-term safety and tolerability of dapirolizumab pegol treatment.
- Trial name
- NCT04976322
- Testing
- Dapirolizumab pegol
- Where
- 123 sites in United States, Argentina and 22 more
- Volunteers
- 760 people
- Sponsor
- UCB Biopharma SRL
Arteriovenous Malformation, Gastrointestinal Bleed
Case-Specific Health Care Professional Clinical Survey for Concerto Versa™ Detachable Coils
The purpose of the Case-Specific Health Care Professional (HCP) Clinical Survey for Concerto Versa™ Detachable Coils, also known as the Concerto Versa HCP Clinical Assessment, is to collect early clinical data from HCPs to assess…
- Conditions
- Arteriovenous Malformation, Gastrointestinal Bleed, Gastric Varices, Hemorrhoid
- Trial name
- NCT07639853
- Testing
- Concerto Versa™ Detachable Coils
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Medtronic Endovascular
Plasma Cell Myeloma
International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefit From Isatuximab
This is a multi-center, open-label, Phase 2 treatment extension study in participants with multiple myeloma who are still benefitting from isatuximab based therapy following completion of a Phase 1, 2, or 3 parental study.
- Trial name
- NCT05669989
- Testing
- Isatuximab intravenous (IV), Cemiplimab (SAR439684), Dexamethasone
- Where
- 37 sites in United States, Australia and 15 more
- Volunteers
- 70 people
- Sponsor
- Sanofi
Parkinson Disease
Quantification of Parkinson's Disease Patients as a Biomarker for Classification, Prediction and Response to Treatment
This is a three-armed open investigational study that aims to differentiate, quantify, and categorize abnormal eye movements and upper limbs movements in patients with Parkinson's disease.
- Trial name
- NCT06586320
- Testing
- 150% of their routine home dopaminergic medications dose right in the clinic, Evaluation of mathematical models
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Stardots AB
Developmental and Epileptic Encephalopathy
A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathy (DEE)
This (DEEp OLE Study) is a multicentre, open-label study to investigate the long-term safety, efficacy, tolerability, and pharmacokinetics (PK) of LP352 in the treatment of seizures in children and adults with DEE who completed…
- Trial name
- NCT06908226
- Testing
- LP352
- Where
- 88 sites in United States, Australia and 15 more
- Volunteers
- 324 people
- Sponsor
- Longboard Pharmaceuticals
Myotonic Dystrophy Type 1 (DM1)
A Study of Long-term Safety and Efficacy of VX-670 in Participants With Myotonic Dystrophy Type I
The purpose of the study is to evaluate the long-term safety and tolerability, efficacy and pharmacokinetics of VX-670 in participants with Myotonic Dystrophy Type I (DM1).
- Trial name
- NCT06926621
- Testing
- VX-670
- Where
- 16 sites in United States, Australia and 6 more
- Volunteers
- 44 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Prader-Willi Syndrome
Observational Study of VYKAT™ XR in Patients With Prader-Willi Syndrome
Prospective observational study developed to generate more evidence of the safety profile, clinical characteristics and outcomes of patients with PWS treated with VYKAT XR.
- Trial name
- NCT07450664
- Testing
- VYKAT XR
- Where
- 25 sites in United States
- Volunteers
- 200 people
- Sponsor
- Soleno Therapeutics, Inc.
Hypofibrinogenemia, Hemorrhage
Cryo-FIRST: Effectiveness of INTERCEPT Fibrinogen Complex (IFC) for Trauma-Associated Hemorrhage
The objective of this multicenter, single-arm, observational study is to determine the feasibility and effectiveness of early administration of FDA-approved, pre-thawed Pathogen Reduced Cryoprecipitated Fibrinogen Complex…
- Conditions
- Hypofibrinogenemia, Hemorrhage, Trauma Associated Hemorrhage, Hemorrhagic Shock
- Trial name
- CRYO-FIRST (NCT07218185)
- Testing
- Pathogen Reduced Cryoprecipitated Fibrinogen Complex
- Where
- 4 sites in United States
- Volunteers
- 320 people
- Sponsor
- Cerus Corporation
Duchenne Muscular Dystrophy (DMD)
An Open-label Long-term Follow-up Study of SAT-3247 for Participants With Duchenne Muscular Dystrophy Including Those Who Participated in SAT-3247-CL-101
This is an open-label long-term safety and efficacy study of orally administered SAT-3247 in patients with DMD including those who previously participated in SAT-3247-CL-101.
- Trial name
- NCT06867107
- Testing
- SAT-3247
- Where
- 6 sites in United States, Australia
- Volunteers
- 30 people
- Sponsor
- Satellos Bioscience, Inc.
ADHD
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
This study is a Phase 3, multi-center, open-label trial to evaluate the long-term safety of solriamfetol in children and adolescents with ADHD.
- Trial name
- NCT07773883
- Testing
- Solriamfetol
- Where
- 7 sites in United States
- Volunteers
- 300 people
- Sponsor
- Axsome Therapeutics, Inc.
Fibromyalgia
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
This is a Phase 3, multi-center, 52-week, open-label trial to evaluate the long-term safety and efficacy of AXS-14 in the management of fibromyalgia.
- Trial name
- NCT07637162
- Testing
- AXS-14 (esreboxetine)
- Where
- 35 sites in United States
- Volunteers
- 300 people
- Sponsor
- Axsome Therapeutics, Inc.
Chronic Rhinosinusitis With Nasal Polyps
Long-term Safety and Efficacy Evaluation of Lunsekimig in Adult Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Completed a Previous Lunsekimig CRSwNP Clinical Study
This is a single-arm extension study to investigate the long-term safety, tolerability, and efficacy of lunsekimig in adult participants with inadequately controlled CRSwNP who have completed a previous lunsekimig CRSwNP clinical…
- Trial name
- ENSEMBLE (NCT06914908)
- Testing
- Lunsekimig, Mometasone furoate nasal spray (MFNS)
- Where
- 24 sites in United States, Argentina and 4 more
- Volunteers
- 71 people
- Sponsor
- Sanofi