Clinical trials: Proof of Concept
Huntington's Disease
Study Exploring Safety, Pharmacokinetic and Pharmacodynamic of BN82451 in Male Huntington's Disease Patients
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of BN82451B versus placebo after oral administration twice daily (bid) for 28 days in patients with Huntington's Disease…
- Trial name
- NCT02231580
- Testing
- BN82451B
- Where
- Germany
- Volunteers
- 17 people
- Sponsor
- Ipsen
HIV-1 Infection
Study to Evaluate the Safety and Efficacy of Teropavimab and Zinlirvimab in Combination With Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection
The primary objective of this study is to evaluate the safety and tolerability of a combination of the broadly neutralizing antibodies (bNAbs) teropavimab (formerly GS-5423) and zinlirvimab (formerly GS-2872) in combination with…
- Trial name
- NCT04811040
- Testing
- Oral Lenacapavir, Subcutaneous Lenacapavir, Teropavimab
- Where
- 23 sites in United States
- Volunteers
- 32 people
- Sponsor
- Gilead Sciences
Uveitis, Intermediate, Uveitis, Posterior
Study of the Effectiveness of Ozurdex for the Control of Uveitis
The main purpose of this study is to evaluate whether or not the dexamethasone pellet (Ozurdex®, Allergan, Irvine, CA) can replace oral corticosteroid (e.g.
- Trial name
- NCT02049476
- Testing
- Dexamethasone pellet
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Johns Hopkins University
Acute Malaria
Phase IIa Proof of Concept Study of M5717-Pyronaridine in Adults and Adolescents With Acute Uncomplicated Plasmodium Falciparum Malaria (CAPTURE 1)
The purpose of this study was to evaluate the safety, efficacy, and pharmacokinetic of the combination M5717 plus pyronaridine in participants with acute uncomplicated Plasmodium falciparum malaria.
- Trial name
- NCT05689047
- Testing
- M5717 330 mg, M5717 500 mg, M5717 660 mg
- Where
- 5 sites in Burkina Faso, Gabon and 2 more
- Volunteers
- 38 people
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
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
Gastroparesis
Study to Assess the Efficacy of VLY-686 in Relieving Symptoms of Gastroparesis
This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in the United States. One hundred fifty (150) subjects diagnosed with gastroparesis, who satisfy the selection criteria for the study, will…
- Trial name
- NCT02970968
- Testing
- VLY-686 (Tradipitant)
- Where
- 38 sites in United States
- Volunteers
- 152 people
- Sponsor
- Vanda Pharmaceuticals
COVID-19
Study of the Use of Favipiravir in Hospitalized Subjects With COVID-19
To determine the effect of favipiravir + SOC v. SOC on COVID-19 viral clearance.
- Trial name
- NCT04358549
- Testing
- Favipiravir, Standard of Care
- Where
- 8 sites in United States
- Volunteers
- 50 people
- Sponsor
- Fujifilm Pharmaceuticals U.S.A., Inc.
Hypertension, Pulmonary, Pulmonary Disease, Chronic Obstructive
Single Dose Study in Patients With Chronic Obstructive Pulmonary Disease (COPD) Associated Pulmonary Hypertension.
This study is to demonstrate the safety, tolerability, pharmakokinetic and pharmacodynamic effect of a single oral dose of BAY63-2521 in patients with pulmonary hypertension due to chronic obstructive pulmonary disease (COPD).
- Trial name
- NCT00640315
- Testing
- Riociguat (Adempas, BAY63-2521) 1.0 mg, Riociguat (Adempas, BAY63-2521) 2.5 mg
- Where
- 7 sites in Germany
- Volunteers
- 23 people
- Sponsor
- Bayer
Diabetes Mellitus, Heart Failure
Results of Tc99m-Maraciclatide Scintigraphy in Subjects With Diabetes Mellitus and Heart Failure With Preserved Left Ventricular Ejection Fraction
The purpose of this study is to evaluate the results of 99mTc maraciclatide scintigraphy in diabetic subjects with HFPEF. A maximum of 20 subjects with Diabetes Mellitus (DM) and Heart Failure With Preserved Left Ventricular…
- Trial name
- NCT01440517
- Testing
- Tc99m-Maraciclatide
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- GE Healthcare
Major Depressive Disorder
Study in Major Depressive Disorder With NMRA-335140 (BTRX-335140) vs Placebo
A proof of concept (POC) study evaluating the impact of NMRA-335140 (BTRX-335140) relative to placebo on symptoms of major depressive disorder (MDD) in adult participants with MDD and symptoms of anhedonia and anxiety following 8…
- Trial name
- NCT04221230
- Testing
- NMRA-335140
- Where
- 38 sites in United States
- Volunteers
- 204 people
- Sponsor
- Neumora Therapeutics, Inc.
Opioid Dependence
XRB vs. SLB in Jail and at Re-entry: Pilot, Proof of Concept
This is a pilot proof-of-concept randomized controlled trial, open-label and unblinded, examining the feasibility and acceptability of Buprenorphine extended-release vs.
- Trial name
- NCT03604159
- Testing
- Buprenorphine Extended Release, Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets)
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- NYU Langone Health
Fatigue
A Proof-of-Concept Trial on the Effect of Ketamine on Fatigue
Background: Many people experience fatigue as a side effect of their illnesses and treatments. There are no medicines to treat fatigue, but a drug called ketamine has reduced fatigue in depressed people.
- Trial name
- NCT04141696
- Testing
- Ketamine, Midazolam
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- National Institute of Nursing Research (NINR)
Kidney Transplant, Hepatitis C
Utilization of Hepatitis C Positive Kidneys in Negative Recipients
To evaluate the safety and feasibility of transplanting kidneys from Hepatitis C virus (HCV) infected donors into recipients without HCV infection
- Conditions
- Kidney Transplant, Hepatitis C, HCV
- Trial name
- NCT03801707
- Testing
- Sofosbuvir / Velpatasvir Oral Tablet [Epclusa], Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet [MAVYRET]
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- Ohio State University
Graft Failure
Study to Investigate the Pharmacokinetics, Pharmacodynamics and Assess the Efficacy and Safety to Support Dose Selection of Emapalumab in Pre-empting Graft Failure in Patients at High Risk After HSCT.
This study is designed as an open-label, single arm, proof of concept study in order to determine the appropriate emapalumab dosing regimen neutralizing IFNγ in patients at risk of GF.
- Trial name
- NCT04731298
- Testing
- Emapalumab
- Where
- 5 sites in Australia, Canada and 1 more
- Volunteers
- 2 people
- Sponsor
- Swedish Orphan Biovitrum
Tourette Syndrome, Chronic Tic Disorder
Proof of Concept Study of an Oral Orthotic to Reduce Tic Severity in Chronic Tic Disorder and Tourette Syndrome
The purpose of this study is to assess the feasibility of a trial on an oral orthotic for reducing tic severity in children ages 7-25 years with Tourette syndrome (TS) or Chronic Tic Disorder (CTD).
- Trial name
- NCT02067819
- Testing
- Active Oral Orthotic Treatment
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Weill Medical College of Cornell University
Malaria, Falciparum
MMV390048 Against Early Plasmodium Falciparum Blood Stage Infection in Healthy Participants
A single-centre, open-label, study using induced blood stage malaria infection to characterize the activity of MMV390048 against early Plasmodium falciparum blood stage infection.
- Trial name
- NCT02281344
- Testing
- MMV390048 20mg
- Where
- Australia
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Medicines for Malaria Venture
Parkinson's Disease
Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of Parkinson Symptoms
The objective of this trial is to evaluate safety and efficacy of rotigotine nasal spray (SPM 952) in a single dose application scheme.
- Trial name
- NCT00296192
- Testing
- Rotigotine nasal spray
- Volunteers
- 82 people
- Sponsor
- UCB Pharma
Diabetic Retinopathy
Evaluation of Effect of Doxycycline Verses Placebo on Retinal Function and Diabetic Retinopathy
This 24 month randomized research study will evaluate whether doxycycline can slow the deterioration or improve retinal function among patients with mild to moderate non-proliferative diabetic retinopathy.
- Trial name
- POC2 (NCT00917553)
- Testing
- doxycycline monohydrate
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Thomas Gardner
Distal Radius Fractures
Proof-of-concept Study With NVDX3 for Treatment of Distal Radius Fractures.
Prospective, single arm, monocentric clinical study to test NVDX3 in patients suffering from distal radius fracture. NVDX3 will be implanted during a single surgical intervention.
- Trial name
- NCT05987033
- Testing
- NVDX3
- Where
- Luxembourg
- Volunteers
- 11 people
- Sponsor
- Novadip Biosciences
Sjogren's Syndrome
Pilot Study of Raptiva to Treat Sjogren's Syndrome
This study will examine the effect of the drug Raptiva (efalizumab) in patients with Sjögren's syndrome (SS), an autoimmune disease affecting the glands producing saliva \& tears.
- Trial name
- NCT00344448
- Testing
- Raptiva
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)