Clinical trials: Proof of Concept
Atrial Fibrillation
Study to Evaluate the Effect of Ranolazine and Dronedarone When Given Alone and in Combination in Patients With Paroxysmal Atrial Fibrillation
The primary objective of this study is to evaluate the effect of ranolazine and of low-dose dronedarone when given alone and in combination at different dose levels on atrial fibrillation burden (AFB) over 12 weeks of treatment.
- Trial name
- HARMONY (NCT01522651)
- Testing
- Ranolazine, Dronedarone
- Where
- 50 sites in United States, Germany and 5 more
- Volunteers
- 134 people
- Sponsor
- Gilead Sciences
Essential Tremor
Evaluate SAGE-547 in Participants With Essential Tremor
Stage 1 is a double-blind, proof-of-concept study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of SAGE-547 Injection in male and female participants with essential tremor in the upper limb.
- Trial name
- NCT02277106
- Testing
- SAGE-547
- Where
- 2 sites in United States
- Volunteers
- 25 people
- Sponsor
- Sage Therapeutics
Multiple Sclerosis
An Open Label, Proof of Concept Study to Evaluate the Effects of Dalfampridine Withdrawal on Gait and Balance Parameters in Subjects With Multiple Sclerosis (MS)
The purpose of this study is to determine changes on overall gait as well as in multiple gait and balance parameters after withdrawal of dalfampridine-ER 10mg in MS subjects who are receiving the medication consistently for at…
- Trial name
- NCT01535664
- Testing
- Withdrawal of dalfampridine-ER 10mg
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Acorda Therapeutics
Necrobiosis Lipoidica Diabeticorum
Secukinumab for NLD (Cosentyx) in Patients With Necrobiosis Lipoidica Diabeticorum (NLD)
This study investigates the efficacy of secukinumab in necrobiosis lipoidica diabeticorum (NLD).
- Trial name
- NCT03791060
- Testing
- Secukinumab
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Beth Israel Deaconess Medical Center
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
Follicular Lymphoma (FL), CLL
ACP-196 (Acalabrutinib) in Combination With Pembrolizumab, for Treatment of Hematologic Malignancies
This study is evaluating the safety, pharmacodynamics (PD), and efficacy of acalabrutinib and pembrolizumab in hematologic malignancies.
- Conditions
- Follicular Lymphoma (FL), CLL, Small Lymphocytic Lymphoma (SLL), Richter's Syndrome
- Trial name
- KEYNOTE145 (NCT02362035)
- Testing
- Acalabrutinib, Pembrolizumab
- Where
- 19 sites in United States
- Volunteers
- 161 people
- Sponsor
- Acerta Pharma BV
Onchocerciasis
Study to Assess Adverse Events, Change in Disease Activity and How Oral ABBV-4083 Capsules When Given Alone or In Combination With Albendazole Capsules Moves in The Body of Adult Participants With Onchocerca Volvulus Infection
Onchocerciasis is a major public health problem in affected countries that causes disease-induced disability, and overall loss of economic productivity.
- Trial name
- NCT04913610
- Testing
- ABBV-4083, Albendazole
- Where
- 2 sites in Democratic Republic of the Congo
- Volunteers
- 153 people
- Sponsor
- AbbVie
Long Bone Delayed-Union Fracture
Phase 1/2a Study on Allogeneic Osteoblastic Cells Implantation in Delayed-Union Fractures
Fracture healing is a complex physiological process caused by interaction of cellular elements, cytokines and signaling proteins, which results in the formation of new bone.
- Trial name
- NCT02020590
- Testing
- ALLOB® implantation
- Volunteers
- 25 people
- Sponsor
- Bone Therapeutics S.A
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Study of the Oral Factor D (FD) Inhibitor ALXN2050 in PNH Patients as Monotherapy
The study will evaluate the efficacy and safety of the oral Factor D (FD) inhibitor ALXN2050 (ACH-0145228) monotherapy in patients with PNH that are treatment naïve, or patients currently treated with eculizumab who still…
- Trial name
- NCT04170023
- Testing
- ALXN2050
- Where
- 11 sites in Canada, Italy and 5 more
- Volunteers
- 29 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Carcinoma, Non-Small-Cell Lung
Pembrolizumab Alone and In Combination With Acalabrutinib (ACP-196) in Subjects With Advanced Non-small Cell Lung Cancer
Pembrolizumab alone and in combination with acalabrutinib in subjects with advanced non-small cell lung cancer.
- Trial name
- KEYNOTE166 (NCT02448303)
- Testing
- Pembrolizumab, Acalabrutinib
- Where
- United States
- Volunteers
- 74 people
- Sponsor
- Acerta Pharma BV
HIV Infections
Proof of Concept Treatment Study of Orally Administered VH4004280 or VH4011499 in HIV-1 Infected Adults
The primary purpose of the study is to evaluate the antiviral activity of orally administered VH4004280 and VH4011499 monotherapy over 10 days in human immunodeficiency virus (HIV-1) infected Treatment-Naïve (TN) participants.
- Trial name
- CINNAMON (NCT06039579)
- Testing
- VH4004280, VH4011499, Antiretroviral therapy
- Where
- 20 sites in United States, Argentina and 7 more
- Volunteers
- 44 people
- Sponsor
- ViiV Healthcare
Acute Myelocytic Leukemia, Acute Lymphocytic Leukemia
Safety and Tolerability of HSC835 in Patients With Hematological Malignancies
This study evaluated the safety and tolerability of using HSC835 in patients with hematological malignancies.
- Conditions
- Acute Myelocytic Leukemia, Acute Lymphocytic Leukemia, Chronic Myelogenous Leukemia, Myelodysplastic Syndrome
- Trial name
- NCT01474681
- Testing
- HSC835
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Novartis Pharmaceuticals
Glaucoma, Ocular Hypertension
6-Week Proof-of-Concept Study of Travoprost/Brinzolamide Ophthalmic Suspension in Subjects With Open-Angle Glaucoma or Ocular Hypertension
The purpose of this study is to evaluate Travoprost/Brinzolamide fixed combination (Trav/Brinz) administered twice daily as compared to each of its marketed components (TRAVATAN Z® solution and AZOPT® suspension) and to the…
- Trial name
- NCT02140060
- Testing
- Dose Level A / Brinzolamide 1% ophthalmic suspension, Dose Level B / Brinzolamide 1% ophthalmic suspension, Dose Level C / Brinzolamide 1% ophthalmic suspension
- Volunteers
- 327 people
- Sponsor
- Alcon Research
Sjögren's Syndrome
Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Primary Sjögren's Syndrome
The primary objective of this study is to evaluate the efficacy of treatment with either lulizumab or BMS-986142 versus placebo in subjects with moderate to severe primary Sjögren's syndrome as measured by the change from…
- Trial name
- NCT02843659
- Testing
- BMS-931699, BMS-986142
- Where
- 34 sites in United States, Australia and 9 more
- Volunteers
- 45 people
- Sponsor
- Bristol-Myers Squibb
ADHD
Vitamin D as a Therapeutic Adjunct in the Stimulant Treatment of ADHD
Specific Aim 1: As part of a within-subject, two-days, study design, to determine whether acute calcitriol (vs. placebo) pre-treatment is associated with greater amphetamine (Amp)-induced dopamine (DA) release in the caudate…
- Trial name
- NCT03103750
- Testing
- Magnetic Resonance Imaging (MRI), PHNO, calcitriol
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Yale University
Leg Ulcer, Diabetic Foot Ulcer
Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia
The purpose of this reseach study is to determine Mölnlycke Health Care´s Leia dressing performance properties is fulfilled and that the dressing is safe when used on wound types such as pressure ulcer, leg ulcer, and diabetic…
- Conditions
- Leg Ulcer, Diabetic Foot Ulcer, Pressure Ulcer
- Trial name
- NCT01966380
- Testing
- Leia
- Where
- Sweden
- Volunteers
- 6 people
- Sponsor
- Molnlycke Health Care AB
COVID-19, Muscle Atrophy
Electrical Stimulation for Critically Ill Post-Covid-19 Patients
Unfortunately, hospital-acquired weakness is highly prevalent among COVID-19 hospitalized patients, who often require prolonged bed-rest or paralytics for an extended period of time in order to maintain oxygenation.
- Conditions
- COVID-19, Muscle Atrophy, Muscle Weakness
- Trial name
- Phase II (NCT05198466)
- Testing
- Electrical Stimulation
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Baylor College of Medicine
Primary Biliary Cholangitis
A Study of Baricitinib (LY3009104) in Participants With Primary Biliary Cholangitis Who do Not Respond or Cannot Take UDCA
This study evaluates the safety and efficacy of baricitinib in participants with primary biliary cholangitis (PBC) who do not respond or are unable to take ursodeoxycholic acid (UDCA).
- Trial name
- NCT03742973
- Testing
- Baricitinib
- Where
- 12 sites in United States, Puerto Rico
- Volunteers
- 2 people
- Sponsor
- Eli Lilly and Company
Kidney Disease, Chronic
A Study of Methoxy Polyethylene Glycol-epoetin Beta (Mircera) in Participants With Chronic Kidney Disease (PRIMAVERA)
This randomized, single-blind, proof-of-concept study will investigate the protective effects of early treatment with Mircera in participants with chronic kidney disease on renal disease progression.
- Trial name
- NCT01194154
- Testing
- Methoxy polyethylene glycol-epoetin beta
- Where
- 33 sites in Germany
- Volunteers
- 241 people
- Sponsor
- Hoffmann-La Roche
Primary Sjögren's Syndrome
A Study of the Safety and Effectiveness of Efgartigimod in Patients With Primary Sjögren's Syndrome (pSS)
The purpose of this study is to assess the efficacy and safety of human FcRn blocking therapy with efgartigimod compared to placebo, in participants with pSS.
- Trial name
- rho (NCT05817669)
- Testing
- Efgartigimod
- Where
- 17 sites in Belgium, Hungary and 2 more
- Volunteers
- 34 people
- Sponsor
- argenx