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NCT ID: NCT04752566 Completed - Clinical trials for Guillain-Barre Syndrome

A Study to Evaluate the Efficacy and Safety of Eculizumab in Guillain-Barré Syndrome

Start date: March 8, 2021
Phase: Phase 3
Study type: Interventional

This is a Phase 3, prospective, multicenter, placebo controlled, double blind, randomized study to investigate the efficacy and safety of eculizumab in participants with severe GBS, defined using the Hughes Functional Grade (FG) scale as progressively deteriorating FG3 or FG4/FG5 within 2 weeks from onset of weakness due to GBS. This study will be conducted only at sites in Japan.

NCT ID: NCT04750577 Completed - Clinical trials for Diabetic Nephropathies

A Study to Test the Effect of Different Doses of BI 685509 on Kidney Function in People With Diabetic Kidney Disease

Start date: April 27, 2021
Phase: Phase 2
Study type: Interventional

This study is open to adults with diabetic kidney disease. The purpose of the study is to find out whether a medicine called BI 685509 improves kidney function. Three different doses of BI 685509 are tested in this study. Participants get either one of the three doses of BI 685509 or placebo. It is decided by chance who gets which BI 685509 dose and who gets placebo. Participants take BI 685509 or placebo as tablets 3 times a day. Placebo tablets look like BI 685509 tablets but do not contain any medicine. Participants continue taking their usual medicine for diabetes and kidney disease throughout the study. Participants are in the study for about 7 months. During this time, they visit the study site about 11 times. Where possible, about 6 of the 11 visits can be done at the participant's home instead of the study site. The trial staff may also contact the participants by phone or video call. Kidney function is assessed based on the analysis of urine samples, which participants collect at home. At the end of the trial the results are compared between the different doses of BI 685509 and placebo. During the study, the doctors also regularly check the general health of the participants.

NCT ID: NCT04746105 Completed - Clinical trials for Patients With Mild Obstructive Sleep Apnea Hypopnea

A Clinical Pharmacology Study of TS-142 in Patients With Obstructive Sleep Apnea Hypopnea.

Start date: February 24, 2021
Phase: Phase 1
Study type: Interventional

A study to evaluate the respiratory safety of TS-142 in patients with mild obstructive sleep apnea hypopnea.

NCT ID: NCT04744493 Completed - Parkinson Disease Clinical Trials

A Clinical Trial for the Safety and Effect of MRGuided FUS Subthalamotomy for Medication Refractory Parkinson's Disease

Start date: May 31, 2019
Phase: N/A
Study type: Interventional

Study design: This is a prospective, open-label, single-center, and sponsor-initiated clinical trial. The clinical trial follows the Clinical Investigation Plan, GCP. Objective: The objective of the clinical trial is to evaluate improving Parkinson's disease motor features by MR-guided focused ultrasound surgery (Patient who has less effectiveness.).

NCT ID: NCT04742699 Completed - Insomnia Clinical Trials

An Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Transitioning to Lemborexant in Japanese Subjects With Insomnia

Start date: March 24, 2021
Phase: Phase 4
Study type: Interventional

This study will be conducted to evaluate whether the approach of direct transitioning to lemborexant (LEM) is supported for insomnia patients who are unsatisfied with current medication. Transition from Following 4 regimens of interest will be investigated; Z-Drug monotherapy, suvorexant (SUV) monotherapy, SUV and benzodiazepine receptor agonists (BZRA) combination therapy, and ramelteon (RMT) and BZRA combination therapy. Patients with insomnia who have been treated with one of the regimens but do not have treatment satisfaction will be enrolled. As a comprehensive indicator of patient satisfaction including treatment efficacy and safety, the proportion of patients with successful transitioning will be evaluated at 2 weeks after transitioning; thus important initial response after transitioning will be evaluated as a primary endpoint. In addition, as a secondary purpose, the treatment continuation, efficacy and tolerability, and the treatment impression for insomnia (Patient Global Impression of Insomnia) for 14 weeks after transitioning will be assessed.

NCT ID: NCT04742556 Completed - Clinical trials for Solid Tumors, KRAS Mutation

A Study to Test Different Doses of BI 3011441 in Japanese People With Different Types of Advanced Cancer (NRAS/KRAS Mutation Positive)

Start date: March 15, 2021
Phase: Phase 1
Study type: Interventional

This study is open to Japanese adults with different types of advanced cancer that are positive for NRAS/KRAS mutations. This is a study in people for whom previous treatment was not successful or no standard treatment exists. The purpose of this study is to find the highest dose of BI 3011441 that Japanese people with advanced cancer can tolerate. BI 3011441 is a medicine that may turn off a signal by NRAS/KRAS that makes tumours grow. Participants take BI 3011441 as capsules once a day. Participants can stay in the study as long as they benefit from treatment and can tolerate it. The doctors collect information on any health problems of the participants.

NCT ID: NCT04740931 Completed - Macular Edema Clinical Trials

A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion

COMINO
Start date: March 2, 2021
Phase: Phase 3
Study type: Interventional

This is a Phase III, multicenter, randomized, double-masked, active comparator-controlled, parallel-group study evaluating the efficacy, safety, and pharmacokinetics of faricimab administered by intravitreal (IVT) injection at 4-week intervals until Week 24, followed by a double-masked period of study without active control to evaluate faricimab administered according to a personalized treatment interval (PTI) dosing regimen in patients with macular edema due to central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO).

NCT ID: NCT04740905 Completed - Macular Edema Clinical Trials

A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Branch Retinal Vein Occlusion

BALATON
Start date: March 2, 2021
Phase: Phase 3
Study type: Interventional

This is a Phase III, multicenter, randomized, double-masked, active comparator-controlled, parallel-group study evaluating the efficacy, safety, and pharmacokinetics of faricimab administered by intravitreal (IVT) injection at 4-week intervals until Week 24, followed by a double-masked period of study without active control to evaluate faricimab administered according to a personalized treatment interval (PTI) dosing regimen in participants with macular edema due to branch retinal vein occlusion (BRVO).

NCT ID: NCT04739761 Completed - Breast Cancer Clinical Trials

A Study of T-DXd in Participants With or Without Brain Metastasis Who Have Previously Treated Advanced or Metastatic HER2 Positive Breast Cancer

DESTINY-B12
Start date: June 22, 2021
Phase: Phase 3
Study type: Interventional

This is open-label, multicenter, international study, assessing the efficacy and safety of Trastuzumab deruxtecan (T-DXd) in participants with or without brain metastasis (BMs), with previously-treated advanced/metastatic HER2-positive breast cancer whose disease has progressed on prior anti-HER2-based regimens and who received no more than 2 lines/regimens of therapy in the metastatic setting (excluding tucatinib).

NCT ID: NCT04736628 Completed - Clinical trials for Chronic Kidney Disease

A Study to Test the Effect of Different Doses of Avenciguat (BI 685509) on Kidney Function in People With Chronic Kidney Disease

Start date: April 27, 2021
Phase: Phase 2
Study type: Interventional

This study is open to adults who have kidney disease that is not caused by diabetes. The purpose of the study is to find out whether a medicine called avenciguat (BI 685509) improves kidney function. Three different doses of avenciguat are tested in this study. Participants get either one of the three doses of avenciguat or placebo. It is decided by chance who gets which avenciguat dose and who gets placebo. Participants take avenciguat or placebo as tablets 3 times a day. Placebo tablets look like avenciguat tablets but do not contain any medicine. Participants continue taking their usual medicine for kidney disease throughout the study. Participants are in the study for about 7 months. During this time, they visit the study site about 11 times. Where possible, about 6 of the 11 visits can be done at the participant's home instead of the study site. The trial staff may also contact the participants by phone or video call. Kidney function is assessed based on the analysis of urine samples, which participants collect at home. At the end of the trial the results are compared between the different doses of avenciguat and placebo. During the study, the doctors also regularly check the general health of the participants.