Clinical trials: Proof of Concept
Cystic Fibrosis
Cystic Fibrosis Treatment Adherence Cayston Proof-of-Concept Pilot Study
Real-world adherence to inhaled and oral therapies for cystic fibrosis (CF) patients remains discouragingly low, ranging between 31-53% for inhaled antibiotics and 41-72% for hypertonic saline.
- Trial name
- NCT02179710
- Testing
- Adherence dashboard motivational interviewing
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Landon Pediatric Foundation
Geographic Atrophy
A Multicenter, Proof-Of-Concept Study Of Intravitreal AL-78898A In Patients With Geographic Atrophy (GA) Associated With Age-Related Macular Degeneration (AMD)
The purpose of this study was to to demonstrate superiority of AL-78898A intravitreal (IVT) injections compared to sham injections by assessing mean geographic atrophy (GA) lesion size change from baseline at Month 12.
- Trial name
- NCT01603043
- Testing
- Al-78898A
- Volunteers
- 10 people
- Sponsor
- Alcon Research
Transcutaneous Vagal Nerve Stimulation (tVNS), Prader-Willi Syndrome
Proof of Concept Study of Vagus Nerve Stimulation
The investigator's recent pilot study of vagus nerve stimulation (VNS) from a surgically implanted medical device to control the excess eating behaviour characteristic of Prader-Willi Syndrome (PWS) found that it was safe and…
- Trial name
- NCT03689621
- Testing
- Transcutaneous vagus nerve stimulation (tVNS)
- Volunteers
- 9 people
- Sponsor
- Jessica Beresford-Webb
Post-traumatic Osteoarthritis of the Knee
Proof of Concept Study Comparing FX006 to Kenalog®-40 in Patients With Post-Traumatic Osteoarthritis of the Knee
This study was a double-blind, randomized, parallel group, proof of concept study comparing FX006 to Kenalog®-40 (triamcinolone acetonide injectable suspension, USP) in patients with post-traumatic osteoarthritis of the knee.
- Trial name
- NCT02468583
- Testing
- FX006 32 mg, TCA IR 40 mg
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Environmental Enteric Dysfunction
Maternal Probiotic Intervention to Improve Gut Health - Trial II - Bangladesh
Burden: Environmental Enteric Dysfunction (EED) is an enteropathic condition characterised by altered gut permeability, infiltration of immune cells and changes in villous architecture and cell differentiation.
- Trial name
- MPIGH-II (NCT06817031)
- Testing
- VE818, Oral Vancomycin
- Where
- Bangladesh
- Volunteers
- 144 people
- Sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
Meibomian Glands, Dry Eye Syndromes
Safety and Efficacy of TrueTear™ for the Treatment of Meibomian Gland Disease
This study will compare the safety and efficacy of TrueTear™ to standardized moist heat compress (Thermalon® Dry Eye Compress) for the treatment of Meibomian Gland Disease (MGD).
- Trial name
- NCT03226769
- Testing
- TrueTear™, Thermalon Dry Eye Compress
- Where
- United States
- Volunteers
- 57 people
- Sponsor
- Allergan
Short Bowel Syndrome
Proof of Concept Study in Patients With Short Bowel Syndrome
This is a Phase I/II. proof of concept, open label, two-dose, dose escalation study of NM-002 in adult patients with SBS who previously responded to exenatide.
- Trial name
- NCT04379856
- Testing
- NM-002
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- 9 Meters Biopharma, Inc.
Tennis Elbow
Efficacy and Safety of TenoMiR in Lateral Epicondylitis
This study is testing a drug called TenoMiR that is being developed for the treatment of tennis elbow (lateral epicondylitis). The study drug is a new compound that works by improving the quality of the collagen which helps…
- Trial name
- NCT06192927
- Testing
- TenoMiR, 0.9% Sodium Chloride Injection
- Where
- 9 sites in United States, United Kingdom
- Volunteers
- 123 people
- Sponsor
- Causeway Therapeutics
Heart Failure, Cardiovascular Diseases
Nene Remote Monitoring Proof of Concept
This feasibility study is being conducted to investigate the practicalities and potential benefits of equipping patients with wearable monitoring devices.
- Conditions
- Heart Failure, Cardiovascular Diseases, Respiratory Disease, Stroke
- Trial name
- NCT04598659
- Where
- United Kingdom
- Volunteers
- 180 people
- Sponsor
- Doccla UK
Parkinson Disease
A Fourteen-Week Placebo-Controlled Dose-Response Efficacy and Safety Study of NS 2330 in Early Parkinson's Disease Patients (Study for Proof of Concept in Early Parkinson's Disease of a Triple Reuptake Inhibitor, NS 2330 / SCEPTRE)
To demonstrate efficacy and dose-response of NS 2330 versus placebo in patients with early Parkinson's Disease in 14 weeks of treatment, and to investigate the safety and tolerability of NS 2330 in these patients.
- Trial name
- NCT00148486
- Testing
- NS 2330
- Where
- 55 sites in United States, Canada
- Volunteers
- 261 people
- Sponsor
- Boehringer Ingelheim
Asthma
VENTURI (VENTilation Using Respiratory Imaging)
The purpose of the study is to enroll participants with uncontrolled asthma to evaluate the large and small airways and drug delivery utilizing two study drugs: Beclometasone dipropionate/Formoterol fumarate…
- Trial name
- VENTURI (NCT07282886)
- Testing
- Beclomethasone Dipropionate/Formoterol Fumarate/Glycopyrrolate pMDI, Fluticasone Furoate/Umeclidinium/Vilanterol 100 MCG/1 ACTUATION-62.5 MCG/1 ACTUATION-25 MCG/1 ACTUATION Inhalation Powder
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Alabama at Birmingham
Point-of-care Ultrasound
AI for Gastric POCUS ( Point-of-care Ultrasound)
The goal of this observational study is to train and test an AI (Artificial Intelligence)-based program to assist anesthesiologists in the interpretation of stomach ultrasound images and differentiate a "full" from an "empty"…
- Trial name
- POCUS (NCT07580456)
- Where
- Canada
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University Health Network, Toronto
COVID-19
Transcranial Non-invasive Electrical Stimulation of the Vagus Nerve in Hospitalized Moderate-to-severe COVID-19 Patients
Subtle Pulse Electro-biological Recovery Apparatus (SPERA) is an innovative device which delivers digital subliminal pulse stimulation trans cranially to auricular branches of the central nervous system and modulates the…
- Trial name
- NCT06767241
- Testing
- Non-invasive auricular vagus nerve stimulation, Standard Medical Therapy
- Where
- Romania
- Volunteers
- 83 people
- Sponsor
- University of Medicine and Pharmacy "Victor Babes" Timisoara
Osteoarthritis, Knee
A Study of LY2828360 in Patients With Osteoarthritic Knee Pain
To investigate the safety, efficacy and pharmacokinetics of single daily oral dose of LY2828360 in male and female subjects with osteoarthritic knee pain
- Trial name
- NCT01319929
- Testing
- LY2828360
- Where
- Denmark
- Volunteers
- 39 people
- Sponsor
- Eli Lilly and Company
HIV Infections
Study of the Antiviral and Immunological Effects of Intensification of Suppressive Antiretroviral Therapy With Maraviroc
Hypothesis: Intensification of current ARV regimens with maraviroc will result in more complete suppression of viral replication, particularly in the gastrointestinal mucosa with resultant reduction in markers of immune…
- Trial name
- NCT00703586
- Testing
- Maraviroc
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Rockefeller University
Hidradenitis Suppurativa
A Study to Test the Efficacy and Safety of SAR442970 in Adults With Hidradenitis Suppurativa
This was a Phase 2 study in adult participants with moderate to severe hidradenitis suppurativa (HS). The purpose of the study was to evaluate the efficacy and safety of SAR442970 compared to placebo.
- Trial name
- HS OBTAIN (NCT05849922)
- Testing
- SAR442970
- Where
- 45 sites in United States, Australia and 13 more
- Volunteers
- 86 people
- Sponsor
- Sanofi
Non-segmental Vitiligo
An Open-label Single Center, Proof of Concept Study Evaluating the Efficacy of Roflumilast Foam 0.3% in Pediatric Patients With Non-Segmental Vitiligo (NSV)
An open-label single center, proof of concept study evaluating the efficacy of Roflumilast foam 0.3% in pediatric subjects with Non-Segmental Vitiligo (NSV)
- Trial name
- NCT07105254
- Testing
- Roflumilast topical 0.3% foam
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Derm Texas, PLLC
Infants, Toddlers
DHA Proof-of-Concept Study in Infants and Toddlers
This is a prospective, double blind, randomized, controlled proof-of-concept study with a parallel group design that aims to investigate the effect of a liquid oral supplement comprising a blend of glycerides at certain…
- Conditions
- Infants, Toddlers, Nutritional Supplement
- Trial name
- DHA (NCT05266677)
- Testing
- blend of glycerides at certain proportions, glycerides used in current formulas
- Volunteers
- healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Dermatitis, Atopic
An Ascending Multiple Dose Study of VTP-38543 in Adult Participants With Mild to Moderate Atopic Dermatitis
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary clinical efficacy of VTP-38543 administered as a cream, twice-daily, for 28 days in otherwise healthy adult…
- Trial name
- NCT02655679
- Testing
- VTP-38543, Vehicle with Transcutol®P, Vehicle without Transcutol®P
- Where
- 12 sites in United States, Canada
- Volunteers
- 104 people
- Sponsor
- Vitae Pharmaceuticals, Inc.
Healthy
A Healthy Volunteer Trial Investigating MR-enterography Image Quality of Lumentin® 44
A healthy volunteer, open, PoC single center trial investigating a new oral contrast agent for use in combination of MR examination of the abdomen and pelvis.
- Trial name
- NCT05781490
- Testing
- Lumentin® 44 Powder for oral foam
- Where
- Sweden
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Lument AB
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