Clinical trials: Proof of Concept
Alzheimer's Disease (AD)
Effects of Auditory Brain Stimulation by "Pink Noise" on Memory Capacities in Alzheimer's Disease: Proof of Concept Study
Alzheimer's disease (AD) is a neurodegenerative disorder affecting almost 6% of the world's population over the age of 65. This disease, in its most typical sporadic form, is characterized by an episodic memory impairment linked…
- Trial name
- PINK-AD (NCT04570761)
- Testing
- Dreem headband
- Where
- France
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- University Hospital, Tours
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
Delirium
CogMe for the Prevention and Early Detection of Delirium
This study is designed as a prospective interventional study to evaluate the CogMe system for early detection and prevention of delirium.
- Trial name
- CogMe (NCT05311761)
- Testing
- CogMe Personal Assistant (PA)
- Where
- Israel
- Volunteers
- 100 people
- Sponsor
- Rambam Health Care Campus
Dementia, Dementia, Vascular
Virtual Individual Cognitive Stimulation Therapy: a Proof of Concept Study
Due to COVID-19, the routine treatment for dementia, Cognitive Stimulation Therapy (CST), is currently suspended in multiple countries. Access to treatment is, therefore, paramount.
- Conditions
- Dementia, Dementia, Vascular, Dementia, Mixed, Dementia With Lewy Bodies
- Trial name
- V-iCST (NCT04828434)
- Testing
- Virtual Individual Cognitive Simulation Therapy
- Where
- United Kingdom
- Volunteers
- 34 people
- Sponsor
- University College, London
Acute Respiratory Distress Syndrome (ARDS)
Identifying an Optimal Corticosteroid Dosage Regimen for Acute Respiratory Distress Syndrome
The early phase of Acute Respiratory Distress Syndrome (ARDS) is characterized by intense alveolar inflammation. Corticosteroids have been used to treat ARDS for decades.
- Trial name
- NCT07711964
- Testing
- No steroids (Arm A), Corticosteroids, low dose for 10 days, Corticosteroids, low dose for 7 days
- Where
- Taiwan
- Volunteers
- 300 people
- Sponsor
- National Taiwan University Hospital
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.
No Disease or Condition is Being Studied, Metabolism
The Effects of Gyngerlean Supplementation on Energy Expenditure
The goal of this randomized controlled study is to asses the effects of a ginger containing supplement on energy expenditure and substrate utilization in healthy men.
- Trial name
- NCT06805201
- Testing
- Gyngerlean
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Nova Southeastern University
Premature (Early) Ejaculation
Proof of Concept Study on BP1.4979 Effect on Primary Premature Ejaculation
The goal of this clinical trial is to learn if drug BP1.4979 works to treat primary premature ejaculation in adults. It will also learn about the safety of drug BP1.4979.
- Trial name
- NCT07047404
- Testing
- BP1.4979
- Where
- France
- Volunteers
- 60 people
- Sponsor
- Bioprojet
Multiple Sclerosis
Evaluation of the Response to Acthar Gel Therapy in Patients Who Failed Intravenous Methylprednisolone (IVMP) for MS Relapses
Although ACTHAR gel is approved for the treatment of acute relapses, it is currently not widely used. Thus, we propose to conduct a small open-label proof-of-concept trial to evaluate the response to ACTHAR gel therapy in…
- Trial name
- NCT01900093
- Testing
- Acthar Gel
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Aaron Miller
Glaucoma
Evaluation of a Novel Head-Mounted Device for Glaucoma Testing: A Proof-of-Concept Study
This proof-of-concept study aims to determine the feasibility and effectiveness of using a custom head-mounted device for visual field testing.
- Trial name
- NCT05030714
- Testing
- Visual Field Testing
- Where
- 2 sites in Canada
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Brennan Eadie
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
Depressive Disorder, Major, Treatment Resistant Depression
Efficacy of Deep Anaesthesia With Isoflurane as a Fast-response Antidepressant Agent
In this study the investigators will submit patients with treatment resistant depression to deep anesthesia with isoflurane to get 15 minutes of cortical burst suppression on electroencephalogram, once a week for six weeks.
- Conditions
- Depressive Disorder, Major, Treatment Resistant Depression, Depressive Episode
- Trial name
- ISORADAR (NCT04171193)
- Testing
- Isoflurane, Sertraline Pill
- Where
- Brazil
- Volunteers
- 30 people
- Sponsor
- University of Sao Paulo
Refractive Error
Proof of Concept Study for First-Sight Refractive Error Correction: Direct Comparison to Manifest Refraction and Autorefraction Results
Proof of concept study is to compare the best corrected visual acuity obtained via First-Sight lenses with the clinical "gold standard" of manifest refraction and autorefraction.
- Trial name
- NCT01342393
- Where
- United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- University of Nebraska
Gut Microbiome, Healthy Adult Male
Effect of Antifungals on the Intestinal Microbiome - a Randomized, Controlled, Proof-of-concept Trial
The goal of this clinical trial is to learn how the antifungal drug fluconazole affects the gut microbiome and immune system in healthy volunteers.
- Conditions
- Gut Microbiome, Healthy Adult Male, Antifungal Therapy
- Trial name
- FAME (NCT07295314)
- Testing
- Fluconazole 200mg tab
- Where
- Netherlands
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ICU Acquired Weakness, Muscle Atrophy
Improved Muscle Metabolism by Combination of Muscle Activation and Protein Substitution ( IMEMPRO )
Intensive Care Unit Acquired Weakness (ICUAW) describes muscle weakness that occurs in around 40% of patients during an intensive care stay.
- Conditions
- ICU Acquired Weakness, Muscle Atrophy, Energy Malnutrition Protein, Quality of Life
- Trial name
- NCT05919940
- Testing
- Dietary Supplement: additional substitution of protein, Neuromuscular electrical stimulation, Early Mobilization
- Where
- 4 sites in Austria, Germany
- Volunteers
- 40 people
- Sponsor
- Technical University of Munich
Erythemato-telangiectatic Rosacea
Safety, Tolerability and Efficacy of BFH772 in Rosacea Patients
This study will evaluate the safety, tolerability and efficacy of BFH772 after 12 weeks of treatment as compared to an active control and vehicle in patients with erythemato-telangiectatic rosacea.
- Trial name
- NCT01449591
- Testing
- BFH772 1% ointment, Vehicle ointment, Noritate® 1% cream
- Where
- 6 sites in United States
- Volunteers
- 36 people
- Sponsor
- Novartis Pharmaceuticals
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.
Ulcerative Colitis
Open Label Study to Assess Safety, PK and Explore Efficacy of OPRX-106 in Patients With Active Mild to Moderate Ulcerative Colitis
This is a proof of concept, randomized, open label, 2-arm study of OPRX-106 in subjects with active mild to moderate ulcerative colitis.
- Trial name
- NCT02768974
- Testing
- OPRX-106
- Where
- 7 sites in Israel
- Volunteers
- 20 people
- Sponsor
- Protalix
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