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NCT ID: NCT04067947 Completed - Pain Clinical Trials

Phase 1 Pharmacokinetics, Safety, and Tolerability Study

Start date: July 8, 2019
Phase: Phase 1
Study type: Interventional

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple Oral Dose Study of the Pharmacokinetics, Safety, and Tolerability of XG005 in Healthy Volunteers.

NCT ID: NCT04060680 Completed - Tachycardia Clinical Trials

Extravascular ICD Pivotal Study

EV ICD
Start date: September 16, 2019
Phase: N/A
Study type: Interventional

Pivotal Summary: The study is designed to demonstrate safety and efficacy of the Extravascular Implantable Cardioverter Defibrillator (EV ICD) System. Continued Access Summary: This study is designed to provide continued access to the Extravascular Implantable Cardioverter Defibrillator (EV ICD) System.

NCT ID: NCT04060199 Completed - Clinical trials for Duchenne Muscular Dystrophy

Study to Assess the Efficacy and Safety of Viltolarsen in Ambulant Boys With DMD (RACER53)

Start date: April 14, 2020
Phase: Phase 3
Study type: Interventional

The main objective of this study is to evaluate the efficacy of Viltolarsen compared to placebo in Duchenne muscular dystrophy (DMD) patients amenable to exon 53 skipping.

NCT ID: NCT04058366 Completed - Cystic Fibrosis Clinical Trials

Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy

Start date: December 5, 2019
Phase: Phase 3
Study type: Interventional

This study evaluated the long-term safety, efficacy, and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for the F508del mutation and a gating or residual function mutation (F/G and F/RF genotypes).

NCT ID: NCT04058353 Completed - Cystic Fibrosis Clinical Trials

A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)

Start date: August 28, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a gating or residual function mutation (F/G and F/RF genotypes).

NCT ID: NCT04058028 Completed - Clinical trials for Systemic Lupus Erythematosus (SLE)

Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE)

Start date: February 19, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if Rozibafusp Alfa could be a useful therapeutic agent in the current treatment landscape where subjects with SLE have ongoing disease activity despite treatment with standard of care therapies.

NCT ID: NCT04056130 Completed - Clinical trials for Atopic Dermatitis (AD)

A Study of Single and Multiple Ascending Doses of KBL697 in Healthy Subjects

Start date: October 4, 2019
Phase: Phase 1
Study type: Interventional

The study is designed to investigate the safety and tolerability of KBL697 in healthy volunteers. KBL697 has been developed as a potential new treatment for atopic dermatitis (AD).

NCT ID: NCT04051827 Completed - Clinical trials for Carcinoma, Non-Small-Cell Lung

Drug-Drug Interaction Study of TAK-788 and Midazolam in Participants With Advanced Non-small Cell Lung Cancer (NSCLC)

Start date: December 23, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to characterize the effect of repeated oral administration of TAK-788 160 milligram (mg) once daily on the single oral and intravenous dose pharmacokinetics (PK) of midazolam.

NCT ID: NCT04050527 Completed - Clinical trials for Adult Lower Limb Spasticity

Study to Assess the Effectiveness of AboBoNT-A Injections for Adult Lower Limb Spasticity in a Real Life Cohort

AboLiSh
Start date: December 19, 2019
Phase:
Study type: Observational

The purpose of the protocol is to assess the longitudinal attainment of person-centered and function related goals of patients who receive AbobotulinumtoxinA (aboBoNT-A) injections for adult lower limb spasticity over a period of 16 months.

NCT ID: NCT04045795 Completed - Multiple Myeloma Clinical Trials

Multi-center, Open-label, Phase 1b Study in Patients With Relapsed/Refractory Multiple Myeloma (RRMM)

Start date: August 6, 2019
Phase: Phase 1
Study type: Interventional

Primary Objectives: - To evaluate the safety and tolerability of isatuximab administered subcutaneously (SC) versus intravenously (IV) - To assess the safety and tolerability (including local injection site tolerability) of isatuximab using the (investigational) isatuximab injector device - To evaluate the pharmacokinetics (PK) of SC and IV isatuximab Secondary Objectives: - To estimate absolute bioavailability of SC and IV isatuximab - To measure receptor occupancy (RO) after isatuximab SC versus IV administration - To assess efficacy of isatuximab after SC and IV administration - To assess patient expectations prior to and patient experience and satisfaction after SC administration - To evaluate potential immunogenicity of SC or IV isatuximab