Clinical trials: Autonomic Neuropathy
PI3K and P110delta Hyperactivation Syndrome
CVL237 Tablets for APDS/PASLI
This study was designed to evaluate the efficacy and safety of CVL237 tablets in patients with APDS/PASLI (activated phosphoinositol 3-kinase δ syndrome /p110 delta-activated mutation leading to senescent T cells…
- Trial name
- NCT06293716
- Testing
- CVL237 tablets
- Where
- China
- Volunteers
- 35 people
- Sponsor
- Convalife (Shanghai) Co., Ltd.
Rheumatoid Arthritis
A Study Investigating the Efficacy and Safety of BGB-45035 Versus Placebo in Adults With Moderate to Severe Active Rheumatoid Arthritis
This study aims to evaluate the efficacy of BGB-45035 in adults with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to conventional synthetic disease-modifying antirheumatic drugs…
- Trial name
- NCT07100938
- Testing
- BGB-45035
- Where
- 29 sites in China
- Volunteers
- 49 people
- Sponsor
- BeiGene
Breast Cancer
A Study of the Experimental Drug BKM120 With Paclitaxel in Patients With HER2 Negative, Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Activation
This study evaluated whether the addition of daily BKM120 to weekly paclitaxel was effective and safe in treating patients with HER2- locally advanced or metastatic breast cancer.
- Trial name
- BELLE-4 (NCT01572727)
- Testing
- Paclitaxel, BKM120
- Where
- 112 sites in United States, Australia and 20 more
- Volunteers
- 416 people
- Sponsor
- Novartis Pharmaceuticals
HR+/HER2-negative Breast Cancer
A Study to Evaluate the Safety and Tolerability of TOS-358 in Women With HR+ HER2- Breast Cancer
The goal of this clinical trial is to evaluate the safety and efficacy of TOS-358 in women with HR+ HER2- metastatic breast cancer whose tumors have a mutation in PIK3CA and who meet all other study enrollment criteria.
- Trial name
- NCT05683418
- Testing
- TOS-358, Fulvestrant, Palbociclib
- Where
- 18 sites in United States, Spain
- Volunteers
- 241 people
- Sponsor
- Totus Medicines
Pulmonary Arterial Hypertension (PAH), Pulmonary Hypertension, Interstitial Lung Disease
A Study of ROC-101 in Patients With Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated With Interstitial Lung Disease (ILD-PH) (ROCSTAR STUDY)
This study evaluates the effect of ROC-101 in adults with either Pulmonary Arterial Hypertension (PAH) or Pulmonary Hypertension Associated with Interstitial Lung Disease (ILD-PH).
- Trial name
- ROCSTAR (NCT07175038)
- Testing
- ROC-101
- Where
- 24 sites in United States, Australia and 7 more
- Volunteers
- 40 people
- Sponsor
- AllRock Bio, Inc.
Tumor, Tumor, Solid
Phase 2 Basket Trial of Nab-sirolimus in Patients With Malignant Solid Tumors With Pathogenic Alterations in TSC1/TSC2 Genes (PRECISION 1)
A Phase 2 multi-center open-label basket trial of nab-sirolimus for adult and adolescent patients with malignant solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 genes
- Conditions
- Tumor, Tumor, Solid, Metastasis, Metastatic Cancer
- Trial name
- NCT05103358
- Testing
- nab-sirolimus
- Where
- 166 sites in United States, Puerto Rico and 1 more
- Volunteers
- 128 people
- Sponsor
- Aadi Bioscience, Inc.
Symptomatic Neurogenic Orthostatic Hypotension (NOH), Non-diabetic Neuropathy
Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH)
The purpose of this study is to see whether droxidopa is effective in treating symptoms of neurogenic orthostatic hypotension in patients with Primary Autonomic Failure (Pure Autonomic Failure, Multiple System Atrophy…
- Conditions
- Symptomatic Neurogenic Orthostatic Hypotension (NOH), Non-diabetic Neuropathy, Primary Autonomic Failure, Dopamine Beta Hydroxylase Deficiency
- Trial name
- NOH302 (NCT00633880)
- Testing
- Droxidopa
- Where
- 54 sites in United States, Australia and 2 more
- Volunteers
- 181 people
- Sponsor
- Chelsea Therapeutics
PIK3CA-Related Overgrowth Spectrum
A Study of the Epidemiology and Hospital Management of Patients With PROS in France
The purpose of this study was to estimate the incidence and prevalence of a group of genetic disorders known as PIK3CA-Related Overgrowth Spectrum (PROS) in France.
- Trial name
- EpiPROS (NCT07222423)
- Where
- United States
- Volunteers
- 3,605 people
- Sponsor
- Novartis Pharmaceuticals
Non-Hodgkin's Lymphoma
Study of Chiauranib in Relapsed/Refractory Non-Hodgkin's Lymphoma
Chiauranib may stop the growth of tumor cells by blocking Aurora kinase B（Aurora B）、VEGFR/PDGFR/c-Kit、CSF-1R targets. This clinical trial is studying the efficacy and safety of chiauranib works in treating patients with relapsed…
- Trial name
- NCT03074825
- Testing
- Chiauranib
- Where
- China
- Volunteers
- 5 people
- Sponsor
- Chipscreen Biosciences, Ltd.
Ovarian Cancer
Tuvusertib Combined With Niraparib or Lartesertib in Participants With Epithelial Ovarian Cancer (DDRiver EOC 302)
The purpose of this study is to measure the effect and safety of treatment with tuvusertib combined with either niraparib or lartesertib in participants with epithelial ovarian cancer and to assess any differences between…
- Trial name
- NCT06433219
- Testing
- Tuvusertib (M1774), Niraparib, Lartesertib (M4076)
- Where
- 84 sites in United States, Australia and 11 more
- Volunteers
- 63 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Polyneuropathy, Amyloid, Neuropathic Pain
Screening for the Transthyretin-Related Familial Amyloidotic Polyneuropathy (TTR FAP)
An International, multicenter, epidemiological observational study investigating the prevalence of Transthyretin-Related Familial Amyloidotic Polyneuropathy (TTR-FAP) in participants with small fiber polyneuropathy of no obvious…
- Conditions
- Polyneuropathy, Amyloid, Neuropathic Pain, Cardiac Failure, Orthostatic Hypotension
- Trial name
- TRAP2-1 (NCT01705626)
- Where
- 11 sites in Austria, Hungary and 4 more
- Volunteers
- 500 people
- Sponsor
- CENTOGENE GmbH Rostock
PIK3CA-Related Overgrowth Spectrum (PROS)
Retrospective Chart Review Study of Patients With PIK3CA-Related Overgrowth Spectrum Who Have Received Alpelisib
The study was a site-based retrospective non-interventional medical chart review of pediatric and adult male and female patients with PIK3CA-Related Overgrowth Spectrum (PROS) who initiated alpelisib at least 24 weeks before the…
- Trial name
- EPIK-P1 (NCT04285723)
- Testing
- alpelisib
- Where
- 7 sites in United States, Australia and 3 more
- Volunteers
- 57 people
- Sponsor
- Novartis Pharmaceuticals
Solid Tumors
Dose Escalation of RMC-5552 Monotherapy in Relapsed/Refractory Solid Tumors
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of escalating doses of RMC-5552 monotherapy in adult participants with relapsed/refractory solid tumors…
- Trial name
- NCT04774952
- Testing
- RMC-5552
- Where
- 8 sites in United States
- Volunteers
- 58 people
- Sponsor
- Revolution Medicines, Inc.
Chronic Pain, Low Back Pain
Research Protocol for Karuna Labs Inc.: Safety and Efficacy of Virtual Reality Graded Motor Imagery for Chronic Pain
The purpose of this study is to investigate, in two phases: (1) the feasibility and safety of Virtual Embodiment Therapy in treating chronic pain of lower back and upper limbs and (2) the efficacy of Virtual Embodiment Therapy on…
- Conditions
- Chronic Pain, Low Back Pain, Fibromyalgia, Upper Extremity Dysfunction
- Trial name
- NCT04060875
- Testing
- Karuna Labs Virtual Reality Software
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Karuna Labs Inc.
Healthy
Study to Evaluate Safety, Tolerability and Pharmacokinetics of rhNGF Eye Drops in Healthy Volunteers
The primary objective of this study is to assess the safety and tolerability of single and multiple ascending doses of rhNGF when administered as eye drops in healthy subjects.
- Trial name
- NGF0112 (NCT01744704)
- Testing
- rhNGF 0.5 µg/mL Sentinel, rhNGF 5 µg/mL Sentinel, rhNGF 20 µg/mL Sentinel
- Where
- 2 sites in Switzerland, United Kingdom
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Dompé Farmaceutici S.p.A
Advanced Solid Tumor
Berzosertib Human Mass Balance Study (DDRiver Solid Tumors 208)
The study was conducted in two periods, Period 1 (mass balance) and Period 2 (extension). The purpose of Period 1 of this study was to provide a quantitative characterization of the mass balance, rates and routes of elimination…
- Trial name
- NCT05246111
- Testing
- [14C]Berzosertib, Berzosertib, Topotecan
- Where
- 2 sites in Hungary
- Volunteers
- 6 people
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Endometriosis
A Clinical Study To Investigate The Effectiveness And Safety Of Tanezumab In Treating Pain Associated With Endometriosis
The purpose of this study is to determine whether tanezumab is effective and safe in the treatment of pain associated with endometriosis.
- Trial name
- NCT00784693
- Testing
- Tanezumab
- Where
- 30 sites in United States
- Volunteers
- 48 people
- Sponsor
- Pfizer
Neuropathy, Diabetic
Fluid Retention in Rosiglitazone Treated Subjects With Autonomic Neuropathy.
Fluid management study in patients with type 2 diabetes and autonomic neuropathy.
- Trial name
- NCT00422955
- Testing
- rosiglitazone
- Where
- Netherlands
- Volunteers
- 36 people
- Sponsor
- GlaxoSmithKline
Non-Small Cell Lung Cancer
Tuvusertib (M1774) in Combination With Cemiplimab in Participants With Non-Squamous NSCLC (DDRiver NSCLC 322)
This is an Open-label, multicenter clinical study conducted in two Phases to establish the efficacy, safety, tolerability, and pharmacokinetics of the ataxia telangiectasia mutated and Rad3-related protein kinase (ATR) inhibitor…
- Trial name
- NCT05882734
- Testing
- M1774, Cemiplimab
- Where
- 54 sites in United States, Belgium and 6 more
- Volunteers
- 61 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Primary Autonomic Failure, Dopamine Beta Hydroxylase Deficiency
Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH) (Droxi-304)
Symptomatic NOH in patients with primary autonomic failure is thought to be a consequence of norepinephrine depletion leading to a diminished capacity to effect an appropriate cardiovascular response to an orthostatic challenge…
- Conditions
- Primary Autonomic Failure, Dopamine Beta Hydroxylase Deficiency, Non-Diabetic Neuropathy, Neurogenic Orthostatic Hypotension
- Trial name
- NOH304 (NCT01132326)
- Testing
- Droxidopa
- Volunteers
- 350 people
- Sponsor
- Chelsea Therapeutics