Clinical trials: Proof of Concept
Autism Spectrum Disorder
A Study of RG7314 to Investigate Efficacy and Safety in Individuals With Autism Spectrum Disorders (ASD)
This multi-center, randomized, double-blind, parallel group, placebo-controlled, proof of concept study will investigate the efficacy and safety of RG7314 in adult participants with ASD.
- Trial name
- NCT01793441
- Testing
- RG7314
- Where
- 56 sites in United States
- Volunteers
- 223 people
- Sponsor
- Hoffmann-La Roche
Hippocampal Hyperactivation, Prodromal Alzheimer Disease
Levetiracetam for Persons at Risk for Alzheimer's Disease
The goal of this clinical trial is to investigate whether very small doses of a drug called levetiracetam (LEV) may reduce elevated brain signaling in individuals who are at an increased risk for developing Alzheimer's Disease…
- Trial name
- ALEVIATE-2 (NCT07477431)
- Testing
- Levetiracetam (LEV)
- Where
- 2 sites in Canada
- Volunteers
- 40 people
- Sponsor
- Sunnybrook Health Sciences Centre
Parkinson Disease
Quality-of-Life Index (Q-Index)
The main objective of this observational study is to use commonly-used connected objects (smartphones and smartwatches) to remotely assess and monitor the health-related quality of life (HrQoL) of people with Parkinson's disease…
- Trial name
- NCT06209502
- Where
- 4 sites in Belgium
- Volunteers
- 95 people, healthy volunteers welcome
- Sponsor
- Koios Care
Healthy Volunteer
A Human Tick Kill Study to Investigate the Safety, Tolerability, and Whole Blood Concentration of TP-05
This is a Phase 2a, randomized, double-blind, proof-of-concept, single-center study evaluating the safety, tolerability, and whole blood concentration of TP-05 (lotilaner) in the killing of ticks after they have attached to human…
- Trial name
- NCT05387083
- Testing
- Low Dose TP-05, High Dose TP-05
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Tarsus Pharmaceuticals, Inc.
Prostate Cancer
Safety, Pharmacokinetic and Proof-of-Concept Study of ARN-509 (Apalutamide) in Castration-Resistant Prostate Cancer (CRPC)
The purpose of this study is to assess the safety and activity of ARN-509 in men with advanced castration resistant prostate cancer.
- Trial name
- NCT01171898
- Testing
- ARN-509 (Phase 1), ARN-509 (Phase 2)
- Where
- 15 sites in United States
- Volunteers
- 127 people
- Sponsor
- Aragon Pharmaceuticals, Inc.
Lipedema
Proof of Concept, Randomized, and Crossover Study, to Assess the Effectiveness of Two Types of Compression Garments in Lipedema
The goal of this prospective randomized crossover experimental study is to assess the effectiveness and tolerance of circular and flat fabric garments in stabilizing lower-limb volume in lipedema.
- Trial name
- LipeGar (NCT06964828)
- Testing
- Flat-knitted compression garment
- Where
- Spain
- Volunteers
- 34 people
- Sponsor
- Isabel Forner-Cordero, MD, PhD
Osteoarthritis, Knee
Study of FX005 for the Treatment of Pain in Patients With Osteoarthritis of the Knee
The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of FX005 for the treatment of pain in patients with osteoarthritis of the knee.
- Trial name
- NCT01291914
- Testing
- FX005
- Where
- 13 sites in Austria, Canada and 2 more
- Volunteers
- 140 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Branch Retinal Vein Occlusion
Proof of Concept Study of Re-treatment in BRVO With Ranibizumab Guided by OCT
The aim of the trial is to evaluate the efficacy and safety of intravitreal injections of ranibizumab for the treatment of macular edema due to BRVO if the re-treatment regimen is guided by morphological macular changes detected…
- Trial name
- RabOCT (NCT01968239)
- Testing
- Ranibizumab
- Where
- Germany
- Volunteers
- 27 people
- Sponsor
- University of Leipzig
Crohn Disease
A Study of JNJ-64304500 as Add-on Therapy in Participants With Active Crohn's Disease
The purpose of this study is to evaluate the efficacy and safety of JNJ-64304500 as add-on therapy to standard of care (SOC) biologic treatment with anti-tumor necrosis factor alpha or anti-interleukin 12/23 inhibitors in…
- Trial name
- DUET (NCT04655807)
- Testing
- JNJ-64304500, Adalimumab, Ustekinumab
- Where
- United States
- Sponsor
- Janssen Research & Development, LLC
Ulcerative Colitis
Safety, Efficacy, and Tolerability Study of ASP3291 in Patients With Active Ulcerative Colitis
This is a Phase 2, randomized, double-blind, multicenter, parallel, placebo controlled study. Approximately 120 eligible patients with mild-to-moderate active ulcerative colitis will be randomized to double blind treatment of…
- Trial name
- NCT01612039
- Testing
- ASP3291
- Volunteers
- 112 people
- Sponsor
- Telsar Pharma Inc.
Uveal Melanoma
Vorinostat in Patients With Class 2 High Risk Uveal Melanoma
This proof-of-concept study will evaluate the ability of vorinostat to induce the transformation of Class 2 uveal melanoma cells into a cell phenotype that resembles normal melanocytes.
- Trial name
- NCT03022565
- Testing
- Vorinostat
- Sponsor
- University of Miami
Parkinson Disease
Vibrotactile Coordinated Reset in Parkinson's Disease - Proof of Concept Study
The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on Parkinson's symptoms. vCR will be administered with a device called the Stanford Glove.
- Trial name
- NCT06028477
- Testing
- Stanford Glove
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Stanford University
Alopecia Areata
A Phase 2a Proof-of-Concept Trial of Bempikibart (ADX-914) for the Treatment of Severe Alopecia Areata (SIGNAL-AA)
Part A is a randomized, double-blind, placebo-controlled, multi-center Proof-of-Concept (POC) Trial in subjects with severe Alopecia Areata. All participants in Part A have completed participation.
- Trial name
- SIGNAL-AA (NCT06018428)
- Testing
- bempikibart (ADX-914)
- Where
- 33 sites in United States, Canada
- Volunteers
- 75 people
- Sponsor
- Q32 Bio Inc.
Skin Care
A Proof of Concept Clinical Study to Investigate the Effects of an Experimental Cosmetic Moisturiser on the Barrier Function of Human Skin on the Face and Forearm
The objective of this POC clinical study is to investigate the impact of the test product (Developmental Cosmetic Moisturising Cream) on skin barrier function and skin moisturisation on the forearm and face after 4 weeks of twice…
- Trial name
- NCT03216265
- Testing
- Test product (Moisturising cream), Positive control (Commercial market place moisturising cream), No treatment
- Where
- Germany
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Mild Cognitive Impairment, Mild Dementia
Brain Health & the Microbiome
The GW SMHS supports research in complementary and integrative approaches to treatment of sickness and disease and for health promotion.
- Conditions
- Mild Cognitive Impairment, Mild Dementia, Alzheimer Disease 1
- Trial name
- bMicrobiome (NCT06039267)
- Testing
- Gut Microbiome Testing
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- George Washington University
Depression
E-MhGAP Intervention Guide in Low- and Middle-income Countries: Proof-of-concept for Impact and Acceptability
Two strategies will be compared for training and supervising primary care workers delivering mental health services. Both strategies will use the World Health Organization mental health Gap Action Program-Intervention Guide.
- Trial name
- EMILIA (NCT04522453)
- Testing
- paper-based version of mental health Gap Action Program-Intervention Guide, digital version of the mental health Gap Action Program-Intervention Guide
- Where
- 2 sites in Nepal, Nigeria
- Volunteers
- 3,351 people, healthy volunteers welcome
- Sponsor
- George Washington University
Hepatocellular Carcinoma
Y-90 Alone or With Sorafenib for Pre-Transplant Hepatocellular Carcinoma
A research study to determine the safety, efficacy, and tolerability of Therasphere® (also known as Y-90, or Y-90 Therasphere) combined with or without sorafenib (Nexavar®), in patients with hepatocellular carcinoma (HCC, or…
- Trial name
- NCT00846131
- Testing
- Sorafenib, Yttrium-90 (Y-90)
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Northwestern University
Netherton Syndrome
Evaluation of Topical ATR12-351 in Adults With Netherton Syndrome
The objectives of this clinical trial are to evaluate the safety and tolerability of topically applied ATR12-351, to understand what the body does to ATR12-351, and to observe treatment benefits of the drug in approximately 12…
- Trial name
- NCT06137157
- Testing
- ATR12-351
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Azitra Inc.
Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Endocarditis
Oritavancin for Staphylococcus Aureus Infections in Opioid Users
This will be a pilot single-arm study consisting of 15 participants evaluating the use of oritavancin in the final consolidation phase (last two weeks of treatment) of systemic infections with Staphylococcus aureus (S.
- Trial name
- NCT03761953
- Testing
- Oritavancin Injection
- Where
- United States
- Sponsor
- University of Pennsylvania
Tissue Preservation
Proof of Concept: Socket Seal
It is planned to evaluate if a porcine collagen matrix (Mucograft Seal) is offering comparable results to free gingival grafts (FGG) in post-extraction tissue preservation.
- Trial name
- SocketSeal (NCT03063775)
- Testing
- BioOss® + Mucograft Seal®, FGG + Bio-Oss®, FGG + Gelatine sponge (Spongostan®)
- Where
- Austria
- Volunteers
- 1 people
- Sponsor
- Medical University of Graz
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