Clinical trials: Treatment Resistant
Healthy Subjects, Castration Resistant Prostate Cancer (CRPC)
A Study to Compare Capsule and Tablet Forms of MDV3100 (Enzalutamide) After Administration of a Single Set Dose Under Fasted Conditions in Healthy Male Subjects
A study to evaluate the bioavailability (BA) of a single oral dose of MDV3100 (enzalutamide) formulated as a solid spray dried tablet compared to oral liquid-filled capsules, and the safety and tolerability of oral formulations.
- Conditions
- Healthy Subjects, Castration Resistant Prostate Cancer (CRPC), Relative Bioavailability, MDV3100
- Trial name
- NCT01911741
- Testing
- MDV3100
- Where
- Germany
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
Hypertension
Rheos® Pivotal Trial
The purpose of this clinical trial is to demonstrate the efficacy and safety of the Rheos system in subjects with hypertension that are resistant to treatment with at least three anti-hypertension agents, one of which is a…
- Trial name
- NCT00442286
- Testing
- Rheos® Baroreflex Hypertension System
- Where
- 44 sites in United States, Germany and 1 more
- Volunteers
- 591 people
- Sponsor
- CVRx, Inc.
Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors
Study of GVV858 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
Phase I: Characterize safety and tolerability of GVV858 as a single agent and in combination with fulvestrant or letrozole. Identify dose range for optimization/recommended dose for further clinical evaluation.
- Conditions
- Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors, Metastatic Castration-resistant Prostate Cancer
- Trial name
- NCT07288359
- Testing
- GVV858, Fulvestrant, Letrozole
- Where
- 16 sites in United States, Canada and 9 more
- Volunteers
- 205 people
- Sponsor
- Novartis Pharmaceuticals
Drug-Resistant Epilepsy, Focal-Onset Seizures
Study to Test the Safety and Efficacy of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adult Subjects With Drug-resistant Epilepsy
The purpose of the study is to evaluate the long-term safety and tolerability of Padsevonil administered at individualized doses as adjunctive treatment for subjects with drug-resistant epilepsy.
- Trial name
- NCT03370120
- Testing
- Padsevonil
- Where
- 156 sites in United States, Australia and 25 more
- Volunteers
- 406 people
- Sponsor
- UCB Biopharma SRL
Diabetes Mellitus
Safety and Efficacy Study of Alogliptin on Glycemic Control in Subjects With Type 2 Diabetes.
The purpose of this study is to determine the safety and efficacy of alogliptin, once daily (QD), compared to diet and exercise, sulfonylurea, metformin and a combination of sulfonylurea and metformin for treating subjects with…
- Trial name
- NCT00755846
- Testing
- Alogliptin
- Volunteers
- 265 people
- Sponsor
- Takeda
Depression, Depressive Disorder
Assessment of the Safety and Effectiveness of Cortical Stimulation in Subjects With Major Depressive Disorder
The purpose of this study is to assess the safety and effectiveness of cortical stimulation to the cerebral cortex of subjects who have suffered from treatment-resistant depression and have failed routine attempts at controlling…
- Trial name
- PROSPECT (NCT00380042)
- Testing
- Cortical Stimulation
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- Northstar Neuroscience
Cytomegalovirus (CMV)
A Study of Maribavir in Chinese Adults With Cytomegalovirus (CMV) Infections
The main aim of this study is to learn how safe maribavir is in Chinese adults who have undergone hematopoietic stem cell or organ transplantation and have a cytomegalovirus (CMV) infection and how well they tolerate treatment…
- Trial name
- NCT06439342
- Testing
- Maribavir
- Where
- 11 sites in China
- Volunteers
- 20 people
- Sponsor
- Takeda
PTSD, Alzheimer Disease
First-In-Human (FIH), Single Ascending Dose (SAD) Study of FluoroEthylNorMemantine (FENM)
The goal of this First-In-Human (FIH) trial is to learn about safety and PharmacoKinetics (PK) in healthy adult volunteers. The main questions it aims to answer are: What is the safety of single ascending doses of the…
- Conditions
- PTSD, Alzheimer Disease, Brain Diseases, Neuro-Degenerative Disease
- Trial name
- NCT05921929
- Testing
- Fluoroethylnormemantine (FENM)
- Where
- Belgium
- Volunteers
- healthy volunteers welcome
- Sponsor
- ReST Therapeutics
Acinetobacter Baumannii-calcoaceticus Complex, Hospital-acquired Bacterial Pneumonia
Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter Baumannii-calcoaceticus Complex
This is a 2-part study, with Part A being the randomized, controlled portion of the study in patients with ABC hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), or bacteremia.
- Conditions
- Acinetobacter Baumannii-calcoaceticus Complex, Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia, Bacteremia
- Trial name
- ATTACK (NCT03894046)
- Testing
- Sulbactam, Durlobactam, Colistin
- Where
- 90 sites in United States, Belarus and 15 more
- Volunteers
- 207 people
- Sponsor
- Entasis Therapeutics
Coronary Artery Disease, Acute Coronary Syndrome
Genotyping Infarct Patients to Adjust and Normalize Thienopyridine Treatment
The objective of GIANT Study is to evaluate the clinical impact of genetic resistance to thienopyridine profile determination (CYP2C19 gene) and the clinical impact of compliance to an adjusted thienopyridine treatment on STEMI…
- Conditions
- Coronary Artery Disease, Acute Coronary Syndrome, Genetic Resistance to Clopidogrel, Compliance to Thienopyridine Treatment
- Trial name
- GIANT (NCT01134380)
- Where
- 12 sites in France
- Volunteers
- 1,500 people
- Sponsor
- Biotronik France
Epilepsy
A Long-term, Safety, Tolerability, and Efficacy Study of Retigabine Immediate-release (IR) in Asian Adults With Partial Onset Seizures
This is a multicentre, long-term, open-label extension (OLE) study to assess the long-term safety, tolerability and efficacy of retigabine immediate-release (IR) as adjunctive therapy in adult Asian subjects with drug-resistant…
- Trial name
- NCT01777139
- Testing
- Retigabine IR
- Where
- 12 sites in Malaysia, South Korea and 1 more
- Volunteers
- 30 people
- Sponsor
- GlaxoSmithKline
Infection, Human Immunodeficiency Virus
Dose-finding Study of GSK2248761 in Antiretroviral Therapy-experienced Subjects With NNRTI-resistant HIV Infection
This 48 week, phase 2b study in 150 HIV-1 infected antiretroviral therapy experienced adult subjects consists of a dose-ranging evaluation of GSK2248761 at blinded doses of 100 mg and 200 mg once daily with a control arm of…
- Trial name
- SONNET (NCT01199731)
- Testing
- GSK2248761 100 mg once daily, GSK2248761 200 mg once daily, Etravirine
- Where
- 41 sites in United States, Belgium and 3 more
- Volunteers
- 30 people
- Sponsor
- ViiV Healthcare
Chronic Hepatitis B
Safety and Antiviral Study of ACH-126, 443 (Beta-L-Fd4C) in the Treatment of Adults With Chronic Hepatitis B Infection.
The purpose of this study is to determine the safety and antiviral HBV activity of ACH-126,443 (beta-L-Fd4C) in the treatment of Subjects of Previous Achillion-Sponsored Phase 1 and 2 Studies in Chronic Hepatitis B Infection.
- Trial name
- NCT00037622
- Testing
- ACH-126, 443 (beta-L-Fd4C)
- Volunteers
- 100 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Treatment Resistant Depression
An Open-Label Study to Evaluate the Safety, Tolerability and Pharmacodynamics of BPL-003 in Patients With Treatment Resistant Depression
An open-label, multi-centre, Phase 2a study to evaluate the safety, tolerability, and pharmacodynamics of one and two doses of intranasal BPL-003 combined with psychological support, in patients with treatment resistant…
- Trial name
- NCT05660642
- Testing
- BPL-003
- Where
- 3 sites in United Kingdom
- Volunteers
- 72 people
- Sponsor
- Beckley Psytech Limited
Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors
Study of ERW316 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
Phase I: Characterize safety and tolerability of ERW316 as a single agent and in combination with fulvestrant or letrozole. Identify dose range for optimization/recommended dose for further clinical evaluation.
- Conditions
- Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors, Metastatic Castration-resistant Prostate Cancer (mCRPC)
- Trial name
- NCT07570966
- Testing
- ERW316, Fulvestrant, Letrozole
- Sponsor
- Novartis Pharmaceuticals
Castration-resistant Prostate Cancer
Disitamab Vedotin in the Treatment With HER2- Expression, Subjects With Locally Advanced or Metastatic Castration-resistant Prostate Cancer
The purpose of this study is to evaluate the effectiveness of Disitamab Vedotin in the treatment of subjects with locally advanced or metastatic castration-resistant prostate cancer.
- Trial name
- NCT06227156
- Testing
- Disitamab Vedotin Injection
- Where
- 3 sites in China
- Volunteers
- 40 people
- Sponsor
- RemeGen Co., Ltd.
Diabetes Mellitus, Type 2
Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM)
The purpose of this study is to assess changes from baseline in insulin sensitivity, hepatic fat content and beta cell function after approximately 24-25 weeks of treatment with canagliflozin compared to placebo in participants…
- Trial name
- NCT02009488
- Testing
- Canagliflozin, 100 mg, Canagliflozin, 300 mg
- Where
- 2 sites in United States
- Volunteers
- 59 people
- Sponsor
- Janssen Research & Development, LLC
Colchicine Resistant/Intolerant Familial Mediterranean Fever
Evaluate the Safety and Efficacy of Canakinumab in Pediatric Patients With Colchicine Intolerant or Colchicine Resistant Familial Mediterranean Fever (FMF)
A study designed to evaluate the role of treatment with a biological agent - Canakinumab in pediatric (age 4-20) Familial Mediterranean Fever (FMF) patients that are intolerant or resistant for colchicine treatment.
- Trial name
- CONTROL FMF (NCT01148797)
- Testing
- Canakinumab
- Where
- 5 sites in Israel
- Volunteers
- 15 people
- Sponsor
- Novartis Pharmaceuticals
Partial Epilepsy
Cenobamate Expanded Access Program (EAP)
This Cenobamate Expanded Access Program (EAP) is designed to continue providing treatment with Cenobamate (YKP3089) to patients with partial-onset epilepsy that were enrolled in the SK Life Science clinical trial YKP3089C013…
- Trial name
- NCT04513860
- Testing
- YKP3089
- Sponsor
- SK Life Science, Inc.
Rifampicin-Resistant Pulmonary Tuberculosis, Multidrug-Resistant Pulmonary Tuberculosis
A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis
This is a Phase 3, randomized, open-label, active-controlled, multicenter trial evaluating the efficacy, safety, and tolerability of quabodepistat-containing regimens for the treatment of rifampicin-resistant or…
- Trial name
- QUANTUM-TB (NCT07209761)
- Testing
- Bedaquiline, Quabodepistat, Pretomanid
- Where
- 42 sites in China, Georgia and 8 more
- Volunteers
- 532 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
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