Clinical trials: Proof of Concept
Anorexia Nervosa
Efficacy and Safety of COMP360 Psilocybin Therapy in Anorexia Nervosa: a Proof-of-concept Study
Efficacy and Safety of COMP360 Psilocybin therapy in Anorexia Nervosa: a Proof-of-concept Study
- Trial name
- NCT05481736
- Testing
- Psilocybin
- Where
- 5 sites in United States, Ireland and 1 more
- Volunteers
- 32 people
- Sponsor
- COMPASS Pathways
Chronic Hepatitis D Infection
Lonafarnib With and Without Ritonavir in HDV (LOWR-1)
To Evaluate the Safety and Efficacy of Lonafarnib with and without Ritonavir Boosting in Adults With Genotype 1 Chronic Hepatitis D Virus (HDV) Infection (LOWR-1).
- Trial name
- LOWR-1 (NCT02430181)
- Testing
- lonafarnib, peginterferon alfa-2a, ritonavir
- Where
- Turkey (Türkiye)
- Volunteers
- 21 people
- Sponsor
- EIT Pharma, Inc.
Osteoarthritis
Proof-of-concept Study to Assess the Efficacy, Tolerability and Safety of a Single Intraarticular Dose of GZ389988 Versus Placebo in Patients With Painful Osteoarthritis of the Knee
Primary Objective: To assess the efficacy of a single intraarticular dose of GZ389988 compared to placebo for relief of knee pain in patients with osteoarthritis (OA) of the knee.
- Trial name
- NCT02845271
- Testing
- GZ389988, acetaminophen or paracetamol, fixed combination of paracetamol + codeine
- Where
- 2 sites in Germany
- Volunteers
- 104 people
- Sponsor
- Genzyme, a Sanofi Company
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
Neuropathy;Peripheral, Chemotherapy-induced Peripheral Neuropathy
BXQ-350 Pharmacokinetic/Pharmacodynamic Study in Cancer Patients
This study will assess pharmacokinetic (PK)/pharmacodynamic (PD) relationships and whether BXQ-350 may decrease the intensity and/or duration of chemotherapy induced peripheral neuropathy (CIPN) thereby improving quality of life…
- Trial name
- RETRO (NCT05291286)
- Testing
- BXQ-350
- Where
- 3 sites in United States
- Volunteers
- 21 people
- Sponsor
- Bexion Pharmaceuticals, Inc.
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.
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
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.
Non-Proliferative Diabetic Retinopathy, Retinal Vein Occlusion
Safety and Proof of Concept Study of ANXV (Annexin A5) in Patients With Diabetic Retinopathy or Retinal Vein Occlusion
The goal of this clinical trial is to learn about the safety of the investigational medicinal product ANXV. It will also learn about how ANXV works to treat non-proliferative diabetic retinopathy and retinal vein occlusion in…
- Trial name
- NEXUS (NCT07259928)
- Testing
- ANXV
- Where
- United Kingdom
- Volunteers
- 12 people
- Sponsor
- Annexin Pharmaceuticals AB
Pancreatic Cancer
Gemcitabine With or Without WX-671 in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed By Surgery
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
- Trial name
- NCT00499265
- Testing
- gemcitabine hydrochloride, Serine Proteinase Inhibitor WX-671
- Where
- 39 sites in Germany, Hungary and 4 more
- Volunteers
- 95 people
- Sponsor
- Heidelberg Pharma AG
Keratoconus
Study of TN-001 Topical Eyedrops for Keratoconus
The goal of this clinical trial is to learn if TN-001, a new eye-drop therapy, is safe and well-tolerated in adult patients with progressive keratoconus.
- Trial name
- NCT07388069
- Testing
- Low-dose TGF-B3 and Dexamethasone Sodium Phosphate, High-dose TGF-B3 and Dexamethasone Sodium Phosphate
- Where
- Australia
- Volunteers
- 20 people
- Sponsor
- TheiaNova Ltd.
Cutaneous Lupus Erythematosus
Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus Erythematosus
Primary Objective: Assess the efficacy of SAR443122 in cutaneous lupus erythematosus (CLE) Secondary Objectives: Assess the effect of SAR443122 on the physician's global assessment of disease activity (PhysGA - disease activity)…
- Trial name
- CLEan (NCT04781816)
- Testing
- SAR443122
- Where
- 50 sites in United States, Argentina and 13 more
- Volunteers
- 78 people
- Sponsor
- Sanofi
Atopic Dermatitis
Proof of Concept Study of Rilzabrutinib in Adult Patients With Moderate-to-severe Atopic Dermatitis
This was a parallel treatment, Phase 2, double-blind, 2-arm, placebo-controlled study with 2 staggered cohorts (2 arms in each cohort) to evaluate the efficacy and safety of rilzabrutinib in adult participants (aged at least 18…
- Trial name
- NCT05018806
- Testing
- Rilzabrutinib
- Where
- 31 sites in United States, Canada and 5 more
- Volunteers
- 124 people
- Sponsor
- Sanofi
HIV Infections
Proof-of-Concept Clinical Pharmacology Trial for HIV Antigen Presentation Therapeutic Biologic Mix
Conducting an initial small, controlled clinical pharmacology trial to assess for therapeutic biologics activity (proof-of-concept) that suggests the potential for clinical benefit of HIV (+) patients 1.
- Trial name
- HIVGP-BCG (NCT07182838)
- Testing
- HIV Therapeutic Biologic Mix - HIV GP160 plus BCG Vaccine Mix for percutaneous use
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Han Xu, M.D., Ph.D., FAPCR, Medical Director, IRB Chair
Parkinson's Disease
Efficacy and Safety Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Wearing-off (COMPOC)
This will be a randomised, crossover, double-blind, double-dummy, active-controlled, multicentre, phase II proof-of-concept study in Parkinson's Disease (PD) patients with end-of-dose wearing-off (motor fluctuations).
- Trial name
- COMPOC (NCT02764125)
- Testing
- Stalevo, levodopa MR
- Where
- 4 sites in Finland, Germany and 2 more
- Volunteers
- 84 people
- Sponsor
- Orion Corporation, Orion Pharma
Viral Conjunctivitis
Therapeutic Efficacy of APD-209 Eye Drops in Treatment of Epidemic Keratoconjunctivitis (EKC)
A randomized, double-masked, placebo-controlled, multi-centre phase IIa proof-of-concept study to evaluate efficacy and safety of APD-209 Eye drops for treatment of acute phase adenovirus-induced EKC.
- Trial name
- NCT01977443
- Testing
- APD-209 Eye drops
- Where
- 10 sites in Germany, Poland and 1 more
- Volunteers
- 47 people
- Sponsor
- Adenovir Pharma AB
Scars, Hypertrophic
Treatment of Fibrotic Scars With Rapid Acoustic Pulse (RAP) Device
A multi-treatment proof of concept clinical study is to evaluate the safety, and efficacy of multiple treatments with Soliton's Rapid Acoustic Pulse (RAP) device for the improvement in the appearance of fibrotic scars
- Trial name
- NCT04702529
- Testing
- Treatment of hypertrophic scars (Soliton's Rapid Acoustic Pulse (RAP) Device)
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Soliton
Risk Behavior, Cognitive Decline
Intervention on Modifiable Lifestyle Risk Factors for Dementia Prevention
The overarching aim is to develop and deploy a multidomain intervention delivered on a mobile application to help older adults reduce their risk for dementia by improving a set of modifiable lifestyle risk factors associated with…
- Trial name
- NCT04616794
- Testing
- Cognitive Engagement Group, Physical Activity Group, Diet Group
- Where
- Canada
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- LuciLab
Skin Aging, Wrinkles in Decolletage
PIEZO-101 First-in-Human Safety and Proof-of-Concept Study
The aim of this first-in-human clinical study is to explore the safety, tolerability, pharmacodynamics, and exploratory efficacy of PIEZO-101, an investigational plasmid DNA biostimulator that aims to restore expression of key…
- Conditions
- Skin Aging, Wrinkles in Decolletage, Wrinkles in Left Knee, Left Knee Skin Laxity
- Trial name
- NCT07671027
- Testing
- PIEZO-101, Piezopen, Sterile Saline (0.9% NaCl)
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Piezo Therapeutics, 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