Clinical trials: Proof of Concept
Infertility Implantation Failure
A Multicentre, Randomised, Double-blind, Placebo-controlled Proof of Concept Study to Compare the Efficacy and Safety of r-hLIF (Emfilermin) for Improving Embryo Implantation Following in Vitro Fertilization (IVF) and Embryo Transfer (ET) in Women With Recurrent Implantation Failure
The primary objective of the study was to provide further clinical and statistical evidence of the efficacy of r-hLIF, in comparison with placebo, administered during the luteal phase after IVF and ET for improving embryo…
- Trial name
- NCT00504608
- Testing
- Emfilermin, recombinant human leukemia inhibitory factor (r-hLIF)
- Volunteers
- 150 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
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
Heart Failure
A Proof-of-concept Trial for OPC 131461 in Patients Hospitalized for Worsening Heart Failure
The primary objective of the study is to compare relative changes in blood N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels after 30 days of treatment in participants with worsening heart failure (WHF), who are…
- Trial name
- NCT06795399
- Testing
- OPC-131461
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Diabetes Type 2
A Study to Evaluate the Safety and Effectiveness of DM199 in Healthy Subjects and Type 2 Diabetes Patients
DM199 (recombinant human tissue kallikrein-1) is a new investigational compound that may eventually be used for the treatment of Diabetes Mellitus Type 2. This is the first time that this compound is being given to humans.
- Trial name
- NCT01845064
- Testing
- DM199
- Where
- Netherlands
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- DiaMedica Therapeutics Inc
Psoriasis, Plaque Psoriasis
Proof of Concept Study of AX-158 in Patients With Mild to Moderate Plaque Psoriasis
Proof of concept study to assess the safety and tolerability of AX-158 in patients with mild to moderate psoriasis. Patients will be evaluated for a 28-day treatment period with either AX-158 or Placebo and then followed for an…
- Trial name
- NCT05725057
- Testing
- AX-158
- Where
- 6 sites in United Kingdom
- Volunteers
- 31 people
- Sponsor
- Artax Biopharma Inc
COVID, Severe Acute Respiratory Syndrome
LSALT Peptide vs. Placebo to Prevent ARDS and Acute Kidney Injury in Patients Infected With SARS-CoV-2 (COVID-19)
To evaluate the proportion of subjects alive and free of respiratory failure (e.g. need for non-invasive or invasive mechanical ventilation, high flow oxygen, or ECMO) and free of the need for continued renal replacement therapy…
- Conditions
- COVID, Severe Acute Respiratory Syndrome, Sars-CoV2, Acute Kidney Injury
- Trial name
- NCT04402957
- Testing
- LSALT peptide
- Where
- 7 sites in United States, Canada and 1 more
- Volunteers
- 61 people
- Sponsor
- Arch Biopartners Inc.
Amyotrophic Lateral Sclerosis
Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZYIL1 in Patients With Amyotrophic Lateral Sclerosis
ZYIL1 is expected to show benefit in patients with Amyotrophic Lateral Sclerosis (ALS). The present study aims to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of ZYIL1 when administered to subjects…
- Trial name
- NCT05981040
- Testing
- ZYIL1 capsules 25 mg and ZYIL1 capsules 50 mg
- Where
- 7 sites in India
- Volunteers
- 24 people
- Sponsor
- Zydus Lifesciences Limited
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
Attention Deficit Hyperactivity Disorder
Safety and Efficacy of GTS21 in Adults With Attention-deficit Hyperactivity Disorder
This study will be a randomized, double-blind, placebo-controlled crossover study to assess the effects of GTS21 (25 mg three times a day (tid), 75 mg tid, 150 mg tid) compared to placebo in non-smoking adults aged 18-55 with a…
- Trial name
- NCT00419445
- Where
- 2 sites in United States
- Volunteers
- 37 people
- Sponsor
- CoMentis
Nonalcoholic Steatohepatitis (NASH), Nonalcoholic Fatty Liver Disease (NAFLD)
Safety, Tolerability, and Efficacy of Selonsertib, Firsocostat, and Cilofexor in Adults With Nonalcoholic Steatohepatitis (NASH)
The primary objective of this study is to evaluate the safety and tolerability of selonsertib, firsocostat, cilofexor, fenofibrate and/or Vascepa® in adults with nonalcoholic fatty liver disease (NAFLD) or nonalcoholic…
- Trial name
- NCT02781584
- Testing
- SEL, FIR, CILO
- Where
- 13 sites in United States, New Zealand
- Volunteers
- 220 people
- Sponsor
- Gilead Sciences
Macular Edema
Study Assessing AR-1105 in Subjects With Macular Edema Due to Retinal Vein Occlusion (RVO)
This study will evaluate the safety, tolerability and efficacy of AR-1105 (dexamethasone implant) for the treatment of macular edema (ME) due to retinal vein occlusion (RVO).
- Trial name
- NCT03739593
- Testing
- AR-1105-CF1, AR-1105-CF2
- Where
- 11 sites in United States
- Volunteers
- 49 people
- Sponsor
- Aerie Pharmaceuticals
Plaque Psoriasis
Safety and Efficacy Study of DUR-928 Topical Solution in Subjects With Plaque Psoriasis
This Phase 2 study has been designed to determine and compare the safety, tolerability, and efficacy of DUR-928 topical solution with that of the vehicle topical solution when applied once daily for approximately four weeks in…
- Trial name
- NCT03837743
- Testing
- DUR-928 Topical Solution, Vehicle Topical Solution
- Where
- 5 sites in United States
- Volunteers
- 25 people
- Sponsor
- Durect
Tourette Syndrome
A Study to Examine the Efficacy of a Therapeutic THX-110 for Tourette Syndrome
This study evaluates the efficacy and safety of THX-110 in the management of tics and other symptoms (e.g. rage attacks, anxiety, depression, sleep difficulties) in patients with Tourette syndrome.
- Trial name
- NCT03651726
- Testing
- THX-110 (dronabinol plus PEA)
- Where
- 2 sites in Germany
- Volunteers
- 60 people
- Sponsor
- Neurothera Labs Inc.
Lupus Nephritis
BIIB023 Proof-of-Concept Study in Participants With Lupus Nephritis
The primary objective of the study is to assess the efficacy of BIIB023 as an add-on treatment to background therapy compared with placebo in combination with background therapy in the treatment of participants with active…
- Trial name
- ATLAS (NCT01499355)
- Testing
- BIIB023, mycophenolate mofetil, oral corticosteroids
- Where
- 58 sites in United States, Argentina and 19 more
- Volunteers
- 276 people
- Sponsor
- Biogen
Muscle Loss, Obesity
Dose-Finding Study Evaluating Effect on Body Composition of Enobosarm in Patients Taking a GLP-1 for Chronic Weight Mgmt
The primary objective of this study is to assess the effect of enobosarm on total lean mass as measured by DEXA in patients maintained on GLP-1 receptor agonists.
- Trial name
- QUALITY (NCT06282458)
- Testing
- Enobosarm, Semaglutide
- Where
- 14 sites in United States
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- Veru Inc.
Painful Diabetic Neuropathy
A Clinical Trial to Study the Effects of GRC 17536 in Patients With Painful Diabetic Neuropathy (Painful Extremities Due to Peripheral Nerve Damage in Diabetic Patients)
Diabetic peripheral neuropathy (DPN) represents a diffuse symmetric and length-dependent injury to peripheral nerves that has major implications on quality of life (QOL), morbidity, and costs from a public health perspective.
- Trial name
- NCT01556152
- Testing
- GRC 17536 (Medium Dose), GRC 17536 (Low Dose)
- Where
- 2 sites in Germany, United Kingdom
- Sponsor
- Glenmark Pharmaceuticals Ltd. India
Diabetic Foot Ulcer
Oral BBR-012 in the Treatment of Diabetic Foot Ulcers, Proof of Concept Study
The aim of this Clinical Proof of Principle study is to evaluate the effect of BBR-012 on the healing of complicated diabetic foot ulcers.
- Trial name
- BBR-012 (NCT01342497)
- Testing
- isoniazide
- Where
- 11 sites in United Kingdom
- Volunteers
- 60 people
- Sponsor
- Bridge BioResearch Ltd.
Diabetic Macular Edema
Multiple Dose Safety and Efficacy of LKA651 in Patients With Diabetic Macular Edema
The primary objectives of this study were to evaluate the safety and efficacy of LKA651 in patients with macular edema from diabetic macular edema (DME),
- Trial name
- NCT03927690
- Testing
- LKA651, Lucentis
- Where
- 22 sites in United States, Germany and 3 more
- Volunteers
- 91 people
- Sponsor
- Novartis Pharmaceuticals
Polymyalgia Rheumatica, Inflammatory Diseases
A 3-arm Proof of Concept Study of AIN457, ACZ885 or Corticosteroids in Patients With Polymyalgia Rheumatica
The study is a two-week, single-blinded, double-dummy, randomized, active-controlled, parallel group design, with a follow-up period up to a total study duration of 6-month, non-randomized, open-label phase to monitor safety…
- Trial name
- NCT01364389
- Testing
- AIN457, ACZ885, Prednisone
- Where
- 6 sites in United States, Germany and 2 more
- Volunteers
- 16 people
- Sponsor
- Novartis Pharmaceuticals
Pulmonary Arterial Hypertension
Tezosentan in Pulmonary Arterial Hypertension
Multicenter, Open-label, Non-comparative, Proof-of-concept, Phase 2a Study to Evaluate the Effect of a Single Infusion of Tezosentan on Pulmonary Vascular Resistance in Patients With Stable, Chronic Pulmonary Arterial…
- Trial name
- NCT01077297
- Testing
- Tezosentan
- Where
- 5 sites in United States, France and 1 more
- Volunteers
- 3 people
- Sponsor
- Idorsia Pharmaceuticals Ltd.