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NCT ID: NCT02633501 Completed - Clinical trials for Blood Brain Barrier Defect

P03277 Dose Finding Study in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

Start date: June 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study was to determine a safe and effective dose of a new gadolinium-based contrast agent (GBCA) P03277 based on the Contrast to Noise Ratio (CNR) when comparing with gadobenate dimeglumine (MultiHance®) at 0.1 mmol/kg body weight (BW). Contrast to Noise Ratio (CNR), a well-known quantitative parameter directly related to contrast medium/GBCA efficacy, was chosen as the primary endpoint in order to have a precise determination of P03277 clinical dose. This was a multi-center, international, prospective, double-blind, randomized, controlled, parallel dose groups, cross-over with comparator study in male and female subjects presenting with known or highly suspected focal areas of disruption of the Blood Brain Barrier including at least one expected enhancing lesion of minimum 5 mm, who were scheduled to undergo a routine contrast-enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System.

NCT ID: NCT02630576 Completed - Electromyography Clinical Trials

Neurostimulation and Electromyographs Assessment of th TetraGraph in Healthy (Volunteers

NEAT-2
Start date: June 2015
Phase: N/A
Study type: Interventional

TetraGraph is a newly developed EMG-based (electromyograph), quantitative, battery-powered neuromuscular monitoring system intended for daily clinical use. The primary aim of this clinical investigation is to examine the applicability (ease of use, equipment need, etc.), repeatability (precision or internal consistency) and performance (signal quality, accuracy of outcome, voltage of stimulation output before and during a stimulus) and tolerability of the Tetragraph device in healthy volunteers.

NCT ID: NCT02627963 Completed - Clinical trials for Carcinoma, Renal Cell

A Study to Compare Tivozanib Hydrochloride to Sorafenib in Participants With Refractory Advanced Renal Cell Carcinoma (RCC)

Start date: May 24, 2016
Phase: Phase 3
Study type: Interventional

This is a Phase 3, open-label, randomized, controlled, multi-national, multi-center, parallel-arm study comparing tivozanib to sorafenib in participants with refractory advanced renal cell carcinoma (RCC). Participants will be randomized (1:1) to treatment with tivozanib or sorafenib. Participants will be stratified by International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk category (favorable; intermediate; poor) and prior therapy (two prior vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR TKI); a prior checkpoint inhibitor [programmed cell death -1 protein (PD-1) or PD-1 ligand (PD1-L) inhibitor] plus a prior VEGFR TKI; a prior VEGFR TKI plus any other systemic agent). All participants will be evaluated for progression free survival, overall survival, objective response rate, and the duration of response as well as safety and tolerability. Pharmacokinetic (PK) analyses are also included in study.

NCT ID: NCT02626572 Completed - Alzheimer's Disease Clinical Trials

Efficacy and Safety of 3 Doses of S47445 Versus Placebo in Patients With Alzheimer's Disease at Mild to Moderate Stages With Depressive Symptoms

Start date: February 2015
Phase: Phase 2
Study type: Interventional

The purpose of this trial is to assess the efficacy and safety of S47445 versus placebo in patients with Alzheimer's disease at mild to moderate stages with depressive symptoms. An optional 28-week extension period will be performed to evaluate safety/tolerance and efficacy of S47445 in co-administration with donepezil.

NCT ID: NCT02625610 Completed - Clinical trials for Unresectable, Locally Advanced or Metastatic, Adenocarcinoma of the Stomach, or of the Gastro Esophageal Junction

Avelumab in First-Line Maintenance Gastric Cancer (JAVELIN Gastric 100)

Start date: December 24, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study was to demonstrate superiority of treatment with avelumab versus continuation of first-line chemotherapy.

NCT ID: NCT02624869 Completed - Clinical trials for Familial Hypercholesterolemia

Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Children With Inherited Elevated Low-density Lipoprotein Cholesterol (Familial Hypercholesterolemia)

HAUSER-OLE
Start date: September 10, 2016
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to describe the safety and tolerability of 80 weeks of subcutaneous (SC) evolocumab when added to standard of care in children 10 to 17 years of age with familial hypercholesterolemia.

NCT ID: NCT02620020 Completed - Low Back Pain Clinical Trials

A Study to Determine the Efficacy and Safety of Fasinumab for the Treatment of Adults With Chronic Low Back Pain

Start date: January 26, 2016
Phase: Phase 2/Phase 3
Study type: Interventional

The main objective of the trial is to evaluate the efficacy of fasinumab compared to placebo as measured by the change from baseline in the average daily Low Back Pain Intensity (LBPI) Numerical Rating Scale (NRS). Secondary objectives of the study are to evaluate the efficacy of fasinumab compared to placebo as measured by: - Change from baseline in the Roland Morris disability questionnaire (RMDQ) total score - Change from baseline in the Patient Global Assessment (PGA) of Low Back Pain (LBP) score - Change from baseline in the average daily LBPI NRS score

NCT ID: NCT02614833 Completed - Clinical trials for Adenocarcinoma Breast Stage IV

IMP321 (Eftilagimod Alpha) as Adjunctive to a Standard Chemotherapy Paclitaxel Metastatic Breast Carcinoma

Start date: December 2015
Phase: Phase 2
Study type: Interventional

The proposed Phase IIb clinical study aims to investigate the safety and efficacy of the active immunotherapy IMP321 in combination (adjunctive) with paclitaxel chemotherapy in patients with hormone receptor-positive metastatic breast cancer.

NCT ID: NCT02614287 Completed - Migraine Clinical Trials

A Safety Study of Galcanezumab in Participants With Migraine, With or Without Aura

Start date: November 30, 2015
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the longer term safety of the study drug known as galcanezumab in participants with episodic or chronic migraine.

NCT ID: NCT02612857 Completed - Dermatomyositis Clinical Trials

Trial of IMO-8400 in Adult Patients With Dermatomyositis

8400-211
Start date: November 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine how safe and effective IMO-8400 is in adults with dermatomyositis.