Clinical trials: Proof of Concept
Fatty Liver, Nonalcoholic, NAFLD
A Study of HTD1801 in Adults With Nonalcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM)
Randomized, double-blind, placebo-controlled, parallel-group study comparing multiple doses of HTD1801 to placebo.
- Conditions
- Fatty Liver, Nonalcoholic, NAFLD, Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
- Trial name
- NCT03656744
- Testing
- HTD1801
- Where
- 17 sites in United States
- Volunteers
- 101 people
- Sponsor
- HighTide Therapeutics (Hong Kong) Limited
Naltrexone, Methylphenidate Abuse
Study for Naltrexone on the Abuse Potential of Methylphenidate
The current abuse liability study aims to assess the potential for co-administration of naltrexone (NTX) to reduce the abuse potential of methylphenidate (MPH).
- Trial name
- NCT03769064
- Testing
- Methylphenidate 60 mg, Treatment Phase Sequence 4213, Treatment Phase Sequence 2134
- Where
- United States
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Avekshan LLC
Faecal Incontinence
The Safety and Dose Response to Single Anal Doses of NRL001
Single centre dose-finding and proof-of-concept study in healthy volunteers to assess the effects of single doses of NRL001 on the mean anal resting pressure (MARP).
- Trial name
- NCT06593743
- Testing
- Perianal NRL001 Gel 3 strengths, Intraanal NRL001 Gel 2 strengths, Intrarectal NRL001 Gel
- Where
- United Kingdom
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Norgine
Endometriosis
PGL2001 Proof of Concept Study in Symptomatic Endometriosis
This is a Phase II, multicentre, randomised, two-arm, parallel group ,double-blind, placebo controlled, study to investigate the efficacy, safety, pharmacokinetics and pharmacodynamics of the steroid sulfatase inhibitor PGL2001…
- Trial name
- AMBER (NCT01631981)
- Testing
- PGL2001 + Primolut-Nor 5
- Where
- 20 sites in Hungary, Poland and 1 more
- Volunteers
- 162 people
- Sponsor
- PregLem SA
Migraine
A Proof of Concept Alleviating the Symptoms of Photosensitive Migraine.
This proof of concept clinical study will investigate the efficacy of active lens with frame in alleviating the symptoms of migraine which are caused by photosensitivity.
- Trial name
- NCT04904328
- Testing
- Lumishade® Active Lens
- Volunteers
- 77 people
- Sponsor
- Mitsui Chemicals, Inc.
Alzheimer Disease, Early Onset
Study to Evaluate the Efficacy, Safety, and Tolerability of an Anti-MTBR Tau Monoclonal Antibody (BMS-986446) in Participants With Early Alzheimer's Disease
The purpose of this study is to assess the effectiveness, safety, and tolerability of BMS-986446 an Anti-MTBR Tau Monoclonal Antibody in participants with Early Alzheimer's Disease.
- Trial name
- TargetTau-1 (NCT06268886)
- Testing
- BMS-986446
- Where
- 176 sites in United States, Australia and 8 more
- Volunteers
- 310 people
- Sponsor
- Bristol-Myers Squibb
Depression
Pipamperone/Citalopram (PipCit)Versus Citalopram in the Treatment of Major Depressive Disorder(MDD)
The primary objective is to demonstrate whether the addition of pipamperone 5 mg twice daily (bd) to citalopram, 40 mg daily in patients suffering from MDD will improve the efficacy of citalopram 40 mg in these patients.
- Trial name
- NCT00672659
- Testing
- Citalopram + Pipamperone, Citalopram
- Where
- United Kingdom
- Volunteers
- 165 people
- Sponsor
- PharmaNeuroBoost N.V.
Alzheimer Disease
Proof-of-Concept Study of a Selective p38 MAPK Alpha Inhibitor, Neflamapimod, in Subjects With Mild Alzheimer's Disease
This is a phase 2b, double-blind, placebo controlled proof-of-concept study of a an oral small molecule selective inhibitor of p38 alpha kinase, neflamapimod, administered for 24 weeks in subjects with mild Alzheimer's disease.
- Trial name
- REVERSE-SD (NCT03402659)
- Testing
- neflamapimod
- Where
- 38 sites in United States, Czechia and 3 more
- Volunteers
- 161 people
- Sponsor
- EIP Pharma Inc
Diabetic Kidney Disease (DKD)
Vascular Endothelial Growth Factor-B (VEGF-B) Blockade With the Monoclonal Antibody CSL346 in Subjects With Diabetic Kidney Disease
This phase 2a, double-blind, randomized, placebo-controlled study will assess the efficacy, safety, tolerability, and pharmacokinetics (PK), of repeat doses of CSL346 in subjects with diabetic kidney disease (DKD) and albuminuria…
- Trial name
- NCT04419467
- Testing
- CSL346
- Where
- 37 sites in United States, Australia and 4 more
- Volunteers
- 114 people
- Sponsor
- CSL Behring
Cough
Repeat Doses of BAY1902607 in Healthy Males and Proof of Concept in Chronic Cough Patients
The primary objectives of this study: To investigate the safety and tolerability of ascending repeated oral doses of BAY1902607 in healthy subjects (Part 1).
- Trial name
- NCT03535168
- Testing
- BAY1902607, Midazolam
- Where
- 8 sites in Netherlands, United Kingdom
- Volunteers
- 59 people
- Sponsor
- Bayer
Neuralgia, Postherpetic, Diabetic Neuropathy
Neuropathic Pain Syndrome Patient Study (MK-0000-072)
The purpose of this study is to determine the best way to conduct clinical trials in patients with neuropathic pain (nerve pain). This study will see if generic pregabalin has any effect on neuropathic pain.
- Conditions
- Neuralgia, Postherpetic, Diabetic Neuropathy, Painful Small-Fiber Neuropathy, Idiopathic Distal Sensory Polyneuropathy
- Trial name
- NCT00570310
- Testing
- Comparator: pregabalin
- Volunteers
- 104 people
- Sponsor
- Merck Sharp & Dohme LLC
Osteoarthritis of the Small Joints of the Hand
Clinical Validation Study of Personalized Orthopedic Splints With 3D Technology in Patients With Rhizarthrosis
Osteoarthritis of the hand is a chronic joint disease that usually affects one or more of the finger joints and it is a major cause of disability.
- Trial name
- NCT04678622
- Testing
- Bioferula3D
- Where
- 2 sites in Spain
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Optimus3D S.L.
Type 2 Diabetes Mellitus
Randomized, Double-Blind, Placebo-Controlled, With PHX1149 in Patients With Type 2 Diabetes Mellitus
This will be a 4-week, multicenter, randomized, double-blind, parallel group, placebo-controlled, safety, tolerability, and efficacy study.
- Trial name
- NCT00530881
- Testing
- PHX1149
- Where
- United States
- Volunteers
- 180 people
- Sponsor
- Phenomix
Sleep Apnea, Sleep Apnea, Obstructive
Evaluation of Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea
This proof-of-concept study is being performed to evaluate whether the hypoglossal nerve can be stimulated using a small series of electrodes placed surgically via a percutaneous approach.
- Conditions
- Sleep Apnea, Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Sleep Disorder
- Trial name
- NCT06283030
- Testing
- Hypoglossal nerve stimulation
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Invicta Medical Inc.
Relapsing-remitting Multiple Sclerosis
A Proof-of-Concept Study to Correlate Retinal Nerve Fiber Layer Changes in Patients With Multiple Sclerosis Treated With Natalizumab or Interferon Beta 1-a
Phase IV, proof-of-concept, randomized, open-label, multi-center, two-arm, 9-month study to evaluate the neuroprotective effects of Natalizumab (TYSABRI®) or Interferon beta-1a (AVONEX®) treatments initiated at the time of…
- Trial name
- PRTOECT (NCT00771043)
- Testing
- TYSABRI and AVONEX
- Sponsor
- Biogen
Androgenetic Alopecia
Activated PRP for Treatment of Androgenetic Alopecia
A clinical trial to assess the effects and safety of PRP activated with pulsed electrical fields (PEFA-PRP) compared with unactivated PRP when used to treat AGA.
- Trial name
- NCT05348343
- Testing
- Autologous platelet-rich plasma
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Santiste Medical Inc.
Type 1 Diabetes Mellitus
TAK-329 Glucose Clamp Study
The purpose of this study is to compare the safety, tolerability, pharmacokinetic and pharmacodynamic properties of single doses of TAK-329 with a single dose of a subcutaneously-injected rapid-acting insulin analog in…
- Trial name
- NCT01311076
- Testing
- TAK-329, Insulin
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- Takeda
Parkinson's Disease Dementia (PDD)
SYN120 Study to Evaluate Its Safety, Tolerability and Efficacy in Parkinson's Disease Dementia (SYNAPSE)
The purpose of this study placebo-controlled, randomized, double-blind study is to assess the safety and efficacy of SYN120 in patients with Parkinson's disease dementia (PDD) already treated with a stable dose of a…
- Trial name
- SYNAPSE (NCT02258152)
- Testing
- SYN120
- Where
- 20 sites in United States
- Volunteers
- 82 people
- Sponsor
- Biotie Therapies Inc.
Acne Rosacea
Safety and Efficacy of ACU-D1 in the Treatment of Acne Rosacea
The study evaluated the safety, tolerability, and efficacy of ACCU-D1 when applied twice daily for 12 weeks in adult participants with moderate to severe acne rosacea.
- Trial name
- NCT03064438
- Testing
- ACCU-D1, Vehicle
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- Accuitis, Inc.
Anxiety Disorders
AZD7325 Proof of Concept in Patients With Generalized Anxiety Disorder (GAD)
The purpose of this research study is to determine whether AstraZeneca's drug AZD7325 is safe and effective in the treatment of generalized anxiety disorder.
- Trial name
- NCT00808249
- Testing
- AZD7325
- Where
- 52 sites in United States
- Volunteers
- 725 people
- Sponsor
- AstraZeneca