Clinical trials: Proof of Concept
Bariatric Surgery
Gaining Optimism After Weight Loss Surgery (GOALS) I
This study examines the feasibility, acceptability, and preliminary impact of an adapted positive psychology-motivational interviewing (PP-MI) intervention for physical activity among patients who have recently undergone…
- Trial name
- GOALS (NCT04867902)
- Testing
- Positive Psychology-Motivational Interviewing Intervention
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Massachusetts General Hospital
Healthy
Task Augmentation of Transcranial Magnetic Stimulation (TMS)
This pilot, within-subjects, randomized proof-of-concept study investigates the effects of activating the DLPFC promotion system on TMS treatment outcomes.
- Trial name
- TaskTMS (NCT04586205)
- Testing
- active TMS, IASP Task, SST Task
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
Proliferative Diabetic Retinopathy (PDR)
Multicenter 12 Months Clinical Study to Evaluate Efficacy and Safety of Ranibizumab Alone or in Combination With Laser Photocoagulation vs. Laser Photocoagulation Alone in Proliferative Diabetic Retinopathy (PRIDE)
The purpose of this study was to assess the efficacy and safety of the anti-Vascular Endothelial Growth Factor (VEGF) agent ranibizumab (0.5 mg) with or without Panretinal laser photocoagulation (PRP) compared to PRP alone in…
- Trial name
- PRIDE (NCT01594281)
- Testing
- Ranibizumab 0.5 mg, Panretinal laser photocoagulation
- Where
- 23 sites in Germany
- Volunteers
- 107 people
- Sponsor
- Novartis Pharmaceuticals
Non-infectious Intermediate Uveitis, Non-infectious Posterior Uveitis
Safety,Tolerability and Efficacy of Intravitreal LFG316 in Patients With Active Non-infectious Intermediate-, posterior-or Panuveitis ,
This was a multi-center, randomized, active-controlled, open-label study. Approximately 24 patients with active, non-infectious intermediate-, posterior-, or panuveitis requiring systemic immunosuppressive therapy were enrolled.
- Conditions
- Non-infectious Intermediate Uveitis, Non-infectious Posterior Uveitis, Non-infectious Panuveitis
- Trial name
- NCT01526889
- Testing
- LFG316, Conventional Therapy
- Where
- 8 sites in United States, United Kingdom
- Volunteers
- 25 people
- Sponsor
- Novartis Pharmaceuticals
Asthma
The Effects of NOx and Conjugated Linoleic Acid on Asthmatics
This study will examine the hypothesis that in obese asthmatics; treatment with NOx + CLA is well tolerated, safe and will increase eNO while reducing airway oxidative stress.
- Trial name
- NICLA (NCT02433977)
- Testing
- Conjugated Linolenic Acid, Sodium Nitrite, Sodium Nitrate
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Gladwin, Mark, MD
Physical Inactivity
MAP to Health Pilot Study: A Physical Activity Intervention for Midlife Adults
The study has two aims: (1) to develop and examine the acceptability of the technological and theoretical frameworks of MAP to Health and (2) to determine whether MAP to Health is related to changes in theoretically identified…
- Trial name
- MAP (NCT05332145)
- Testing
- MAP to Health
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- HealthPartners Institute
Pemphigoid, Bullous
Evaluation of Safety, Efficacy and Pharmacodynamic Effect of Bertilimumab in Patients With Bullous Pemphigoid
This is an open-label, proof-of-concept, single group study in adult participants with newly diagnosed, moderate to extensive BP.
- Trial name
- NCT02226146
- Testing
- Bertilimumab
- Where
- 8 sites in United States, Israel
- Volunteers
- 11 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Parkinson Disease
Revitalize Cognition: Near Infrared Stimulation in Parkinson Patients
The overall goal of this pilot, proof of concept study is to test a novel, relatively low cost, low risk and potentially high impact intervention for cognitive and motor symptoms associated with idiopathic Parkinson Disease.
- Trial name
- NCT06688357
- Testing
- Active NIR-PBM (MedX 1116, MCT502)
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- University of Florida
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
C3 Glomerulopathy, C3 Glomerulonephritis
A Proof-of-Concept Study of Danicopan for 6 Months of Treatment in Participants With C3 Glomerulopathy (C3G)
The primary purpose of this proof-of-concept clinical study was to evaluate the efficacy and safety of the study drug, ACH-0144471 (also known as danicopan and ALXN2040), in participants with C3G who also had significant…
- Conditions
- C3 Glomerulopathy, C3 Glomerulonephritis, Dense Deposit Disease
- Trial name
- NCT03369236
- Testing
- Danicopan
- Where
- 7 sites in United States, United Kingdom
- Volunteers
- 13 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Obsessive-Compulsive Disorder, Trichotillomania (Hair-Pulling Disorder)
Epidiolex in Obsessive Compulsive Disorder and Related Disorders
The primary objective of the proposed study is to evaluate the safety and efficacy of Epidiolex (cannabidiol) in adults with obsessive compulsive and related disorders (OCRDs).
- Conditions
- Obsessive-Compulsive Disorder, Trichotillomania (Hair-Pulling Disorder), Tourette Syndrome, Hoarding Disorder
- Trial name
- NCT04978428
- Testing
- Cannabidiol
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- University of Chicago
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Study of the Oral Factor D (FD) Inhibitor ALXN2050 in PNH Patients as Monotherapy
The study will evaluate the efficacy and safety of the oral Factor D (FD) inhibitor ALXN2050 (ACH-0145228) monotherapy in patients with PNH that are treatment naïve, or patients currently treated with eculizumab who still…
- Trial name
- NCT04170023
- Testing
- ALXN2050
- Where
- 11 sites in Canada, Italy and 5 more
- Volunteers
- 29 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Chronic Obstructive Pulmonary Disease, Emphysema
Belimumab Treatment of Emphysema Patients With Anti-GRP78 Autoantibodies
This is intended to be an initial "proof-of-concept" study to show feasibility, validate assays and approaches, and explore dosing and safety of belimumab in pulmonary emphysema patients who have clinically relevant (and…
- Trial name
- BOTEGA (NCT03244059)
- Testing
- Belimumab
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- University of Alabama at Birmingham
Attention-Deficit/Hyperactivity Disorder, ADHD
A Study of TD-9855 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
The safety and efficacy of multiple dosages of TD-9855, administered once daily, will be evaluated in adult males with ADHD.
- Trial name
- NCT01458340
- Testing
- TD-9855
- Where
- 17 sites in United States
- Volunteers
- 295 people
- Sponsor
- Theravance Biopharma
Sars-CoV2
Rhu-pGSN for Severe Covid-19 Pneumonia
Study Objectives: Primary To assess the efficacy (survival without organ failure on Day 14) of three doses of rhu-pGSN administered intravenously (IV) plus standard of care (SOC) to hospitalized subjects with a primary diagnosis…
- Trial name
- NCT04358406
- Testing
- Recombinant human plasma gelsolin (Rhu-pGSN)
- Where
- 3 sites in Romania, Spain
- Volunteers
- 64 people
- Sponsor
- BioAegis Therapeutics Inc.
Hereditary Hemorrhagic Telangiectasia
Topical Anti-angiogenic Therapy for Telangiectasia in HHT: Proof of Concept
Hereditary hemorrhagic telangiectasia (HHT) is a hereditary vascular condition characterized by the development of abnormal connections between arteries and veins throughout the body, called vascular malformations.
- Trial name
- NCT01752049
- Testing
- Topical timolol maleate
- Where
- Canada
- Volunteers
- 5 people
- Sponsor
- Unity Health Toronto
Epilepsy
Open-Label PoC Trial of Ganaxolone in Children With PCDH19 Female Pediatric Epilepsy and Other Rare Genetic Epilepsies
To evaluate the efficacy of open-label ganaxolone as adjunctive therapy for uncontrolled seizures in female children with PCDH19 mutation and other rare genetic epilepsies in an open-label proof-of-concept study.
- Trial name
- NCT02358538
- Testing
- Ganaxolone
- Where
- 10 sites in United States, Italy
- Volunteers
- 30 people
- Sponsor
- Marinus Pharmaceuticals
Acute Anterior Uveitis
Proof of Concept Study to Evaluate Safety and Efficacy of LME636 in the Treatment of Acute Anterior Uveitis
The purpose of the study is to determine whether topical ocular administration of LME636 60 mg/mL is efficacious in resolving the ocular inflammation in the anterior chamber (AC) associated with acute anterior uveitis (AAU).
- Trial name
- NCT02482129
- Testing
- LME636 60 mg/mL ophthalmic solution, Dexamethasone 0.1% ophthalmic solution, LME636 Vehicle
- Volunteers
- 45 people
- Sponsor
- Alcon Research
Dry Eye
The Effects of a Single Intravenous Administration of Secukinumab (AIN457) or Canakinumab (ACZ885) in Dry Eye Patients
This study assessed the effects of a single intravenous dose of secukinumab (AIN457) 10 mg/kg or canakinumab (ACZ885) 10 mg/kg on the signs and symptoms of dry eye.
- Trial name
- NCT01250171
- Testing
- Secukinumab 10 mg/kg, Canakinumab 10 mg/kg
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- Novartis Pharmaceuticals
Alzheimer's Disease
Valproic Acid in Subjects With Intact Cognition - Proof of Concept Study
The purpose of this study is to evaluate the safety of administration and effects of valproic acid on clusterin expression in cognitively-intact, healthy, elderly subjects.
- Trial name
- VPA (NCT01729598)
- Testing
- Valproic Acid
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Gregory Jicha, 323-5550