Clinical trials: Proof of Concept
Antiphospholipid (aPL)-Positive
Phase IIa Trial of ALXN1007 for the Treatment of Non-criteria Manifestations of Antiphospholipid Syndrome
The primary purpose of this study was to evaluate the safety and tolerability of intravenous (IV) ALXN1007 in persistently antiphospholipid (aPL)-positive patients with at least 1 of the following non-criteria manifestations of…
- Trial name
- NCT02128269
- Testing
- Study Drug- ALXN1007
- Where
- 9 sites in United States, Brazil and 4 more
- Volunteers
- 9 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Treatment for Basal Cell Carcinomas (BCCs) in Gorlin Syndrome Patients
A Trial to Evaluate the Safety, Local Tolerability, Pharmacokinetics and Pharmacodynamics of LDE225 on Skin Basal Cell Carcinomas in Gorlin Syndrome Patients
Part I was a double-blind, randomized, vehicle-controlled Proof of Concept (PoC) study to evaluate the safety, local tolerability, pharmacokinetics and pharmacodynamics of multiple topical administrations of LDE225 (a specific…
- Trial name
- NCT00961896
- Testing
- Vehicle, LDE225 0.25%, LDE225 0.75%
- Where
- 3 sites in Austria, Switzerland
- Volunteers
- 18 people
- Sponsor
- Novartis Pharmaceuticals
Postpartum Depression
Evaluate SAGE-547 in Female Participants With Severe Postpartum Depression
This is an open-label proof-of-concept study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of SAGE-547 Injection in adult female participants diagnosed with severe postpartum depression (PPD).
- Trial name
- NCT02285504
- Testing
- SAGE-547
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Supernus Pharmaceuticals, Inc.
Paroxysmal Nocturnal Hemoglobinuria
Proof of Concept Study to Assess the Efficacy, Safety and Pharmacokinetics of LFG316 in Patients With Paroxysmal Nocturnal Hemoglobinuria
The purpose of this study was to determine whether LFG316 can induce a hematological response, as measured by reduction in hemolytic activity, in patients with paroxysmal nocturnal hemoglobinuria (PNH).
- Trial name
- NCT02534909
- Testing
- LFG316, LNP023
- Where
- 7 sites in Czechia, Japan and 1 more
- Volunteers
- 10 people
- Sponsor
- Novartis Pharmaceuticals
Prostate Cancer
Study to Assess the Efficacy of Brachytherapy With or Without Hormone Therapy, Using Triptorelin 22.5mg in Patients With Recurrence of Prostate Cancer
The primary objective of the study was to compare the efficacy of brachytherapy versus brachytherapy + triptorelin 22.5 mg (single injection) in subjects with recurrence of prostate cancer previously treated with radiotherapy.
- Trial name
- ANABRAQ (NCT01374087)
- Testing
- Triptorelin 22.5 mg, Brachytherapy
- Where
- 11 sites in Spain
- Volunteers
- 32 people
- Sponsor
- Ipsen
Fibromyalgia
A Study to Test the Effectiveness and Safety of Fremanezumab on Participants With Fibromyalgia
The primary objective of the study is to estimate the treatment effect of fremanezumab administered subcutaneously (SC) in reducing pain in adult participants with fibromyalgia (FM).
- Trial name
- NCT03965091
- Testing
- Fremanezumab
- Where
- 49 sites in United States
- Volunteers
- 189 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Covid19
Effect of Dalcetrapib in Patients With Confirmed Mild to Moderate COVID-19
This study is a placebo-controlled, Phase 2a proof-of-concept clinical study which will evaluate efficacy and safety of dalcetrapib in outpatients patients with mild to moderate, symptomatic, confirmed COVID 19.
- Trial name
- NCT04676867
- Testing
- Dalcetrapib
- Where
- Canada
- Volunteers
- 227 people
- Sponsor
- DalCor Pharmaceuticals
Heartburn
Proof of Concept Study Efficacy of an Antacid/Lansoprazole Combination for Relief of Heartburn
This study will investigate the safety and efficacy of an antacid/Lansoprazole combination product for the relief of heartburn after consuming a heartburn-inducing meal.
- Trial name
- NCT01037452
- Testing
- Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg, Lansoprazole, Calcium carbonate/magnesium hydroxide
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Novartis
Mycobacterium Avium Complex, Non-tuberculous Mycobacterium Pulmonary Disease
Safety, Tolerability, Pharmacokinetics and Efficacy of SPR720 for the Treatment of Patients With Mycobacterium Avium Complex (MAC) Pulmonary Disease
To evaluate the pharmacokinetics (PK) of SPR719, the active moiety, generated from the orally (po) administered SPR720 prodrug in a patient population with nontuberculous mycobacteria pulmonary disease (NTM-PD)
- Trial name
- NCT04553406
- Testing
- SPR720, Open-label Standard of Care
- Where
- 9 sites in United States
- Volunteers
- 2 people
- Sponsor
- Spero Therapeutics
Gastroesophageal Reflux
Comparison of Vonoprazan to Esomeprazole in Participants With Symptomatic GERD Who Responded Partially to a High Dose of Proton Pump Inhibitor (PPI)
The purpose of this study is to determine the effect of vonoprazan compared to esomeprazole for preventing heartburn symptoms over a 4-week treatment period in participants who have a partial response to treatment with…
- Trial name
- NCT02743949
- Testing
- Vonoprazan, Esomeprazole
- Where
- 39 sites in Belgium, Bulgaria and 4 more
- Volunteers
- 256 people
- Sponsor
- Takeda
Radiculopathy Lumbar
A Two-part Proof-of-Concept Study Assessing the Safety and Efficacy of LAT8881 in Lumbar Radicular Pain
The study consists of two parts. Part A will evaluate the safety and tolerability of intravenous LAT8881 in healthy volunteers using an ascending dose schedule.
- Trial name
- NCT05298306
- Testing
- LAT8881
- Where
- Australia
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Lateral Pharma Pty Ltd
Insomnia, Sleep
Frequen-ZZZ SleepPad Investigational Device POC
The investigators propose to examine the potential effects of the Frequen- ZZZ sleep pad - a noninvasive, unobtrusive appliance that generates a localized low-level electromagnetic field via radiofrequency, and that is used on…
- Conditions
- Insomnia, Sleep, Sleep Disturbance
- Trial name
- NCT05908344
- Testing
- Activated Sleep Pad system (Frequen-ZZZ), Deactivated Sleep Pad system (Frequen-ZZZ)
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Kunasan Inc.
Primary Biliary Cholangitis, Primary Biliary Cirrhosis
Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis
The purpose of this open-label study is to evaluate the safety and tolerability of HDT1801 (BUDCA) over 12 weeks in adult subjects with PBC who have an inadequate response to standard therapy.
- Conditions
- Primary Biliary Cholangitis, Primary Biliary Cirrhosis, Cholangitis, Cholestasis
- Trial name
- PRONTO-PBC (NCT04604652)
- Testing
- HTD1801 (BUDCA)
- Where
- 12 sites in United States
- Volunteers
- 24 people
- Sponsor
- HighTide Therapeutics (Hong Kong) Limited
FSGS, MCD
Tumor Necrosis Factor Inhibition in Focal Segmental Glomerulosclerosis and Treatment Resistant Minimal Change Disease
Adalimumab, a treatment which blocks tumor necrosis factor (TNF), was tested to see if it changed levels of urine biomarker levels, tissue inhibitor of metalloprotease-1 (TIMP1), and monocyte chemoattractant protein-1 (MCP1).
- Conditions
- FSGS, MCD, Focal Segmental Glomerulosclerosis, Minimal Change Disease
- Trial name
- NCT04009668
- Testing
- adalimumab
- Where
- 4 sites in United States
- Volunteers
- 7 people
- Sponsor
- University of Michigan
Sleep Apnea, Obstructive
Safety and Efficacy Study of Dronabinol to Treat Obstructive Sleep Apnea
This is a proof of concept study to determine the safety and efficacy of dronabinol for the treatment of obstructive sleep apnea syndrome (OSA).
- Trial name
- PACE (NCT01755091)
- Testing
- Dronabinol
- Where
- 2 sites in United States
- Volunteers
- 75 people
- Sponsor
- University of Illinois Chicago
Elective Surgery
Telemedicine Control Tower for the Post-Anesthesia Care Unit
A single center prospective before-and-after proof-of-concept study to evaluate a telemedicine center for the PACU.
- Trial name
- PACU Telemed (NCT04020887)
- Testing
- Alertwatch - Interaction
- Where
- United States
- Volunteers
- 560 people
- Sponsor
- Washington University School of Medicine
Pain, Cancer
A Phase 2a, Proof-of-Concept Study of GIC-1001 in the Management of Visceral Pain During Sedation-Free, Full Colonoscopy
GIC-1001 is a novel, orally-administered, colonic analgesic drug developed as an alternative to i.v. sedation during full colonoscopy.
- Conditions
- Pain, Cancer, Colonic Diseases
- Trial name
- NCT01926444
- Testing
- GIC-1001
- Where
- 15 sites in United States, Canada
- Volunteers
- 308 people
- Sponsor
- gicare Pharma Inc.
Emphysema
Prostaglandin Inhibition for Emphysema
The Prostaglandin Inhibition for Emphysema (PIE) study will determine if a currently available therapy, ibuprofen 600 mg three times daily, can block PGE production in the lower respiratory tract and if this results in…
- Trial name
- PIE (NCT02006576)
- Testing
- 600 mg ibuprofen three times daily for 48 weeks
- Where
- 5 sites in United States
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- University of Nebraska
Influenza
The Effectiveness of CD388 to Prevent Flu in an Influenza Challenge Model in Healthy Adults
The purpose of this study is to evaluate the preventative antiviral activity of CD388, as compared to saline placebo, when administered as a single dose to healthy adult participants in a human viral challenge model of influenza.
- Trial name
- NCT05523089
- Testing
- CD388
- Where
- United Kingdom
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Alzheimer Disease
Proof-of-Concept Study of a Selective p38 MAPK Alpha Inhibitor, Neflamapimod, in Subjects With Mild Alzheimer's Disease
This is a phase 2b, double-blind, placebo controlled proof-of-concept study of a an oral small molecule selective inhibitor of p38 alpha kinase, neflamapimod, administered for 24 weeks in subjects with mild Alzheimer's disease.
- Trial name
- REVERSE-SD (NCT03402659)
- Testing
- neflamapimod
- Where
- 38 sites in United States, Czechia and 3 more
- Volunteers
- 161 people
- Sponsor
- EIP Pharma Inc