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NCT ID: NCT03323749 Terminated - Clinical trials for Primary Mitochondrial Myopathy

A Trial to Evaluate Safety and Efficacy of Elamipretide Primary Mitochondrial Myopathy Followed by Open-Label Extension

MMPOWER-3
Start date: October 9, 2017
Phase: Phase 3
Study type: Interventional

This is a multicenter phase 3 randomized, double-blind, parallel-group, placebo-controlled trial to evaluate the safety and efficacy of daily subcutaneous injections of elamipretide in subjects with primary mitochondrial myopathy. This will be followed by an open-label treatment extension.

NCT ID: NCT03322215 Terminated - Clinical trials for Breast Cancer Metastatic

HR+/HER2- Advanced Breast Cancer and Endocrine Resistance

PASIPHAE
Start date: October 24, 2017
Phase: Phase 2
Study type: Interventional

This is a randomized, 2-arm, open-label, multicenter, international phase II trial. A total of 196 patients will be included. The study will include patients with metastatic Hormone Receptor positive / Human Epidermal Growth Factor Receptor (HER2) negative breast cancer with progressive disease after endocrine treatment. Patients will be randomized (1:1) between two treatment arms: A. palbociclib + fulvestrant and b. capecitabine.

NCT ID: NCT03318523 Terminated - Parkinson's Disease Clinical Trials

Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants With Parkinson's Disease

SPARK
Start date: January 10, 2018
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to evaluate the clinical efficacy of BIIB054 via dose response using the change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score. The secondary objectives of the study are to evaluate the dose-related safety of BIIB054, to evaluate the clinical efficacy of BIIB054 via MDS-UPDRS total score, to assess the pharmacokinetic (PK) profile of BIIB054, to evaluate the clinical efficacy of BIIB054 based on MDS-UPDRS subparts, to evaluate the pharmacodynamic effects of BIIB054 on the integrity of nigrostriatal dopaminergic nerve terminals and to evaluate the immunogenicity of BIIB054.

NCT ID: NCT03318250 Terminated - Neuropathic Pain Clinical Trials

TransGrade Multimodal Neuromodulation of the Dorsal Root Ganglion Ensemble for Refractory Neuropathic Pain

Start date: June 12, 2018
Phase: N/A
Study type: Interventional

This a single center study comparing two forms of electrical stimulation: sub-sensory burst stimulation (DRG-Burst3D) and standard low frequency stimulation (DRG-LF) in the dorsal root ganglion of subjects diagnosed with neuropathic pain

NCT ID: NCT03317496 Terminated - Clinical trials for Non-small Cell Lung Cancer

Safety And Efficacy Study Of Avelumab Plus Chemotherapy With Or Without Other Anti-Cancer Immunotherapy Agents In Patients With Advanced Malignancies

Start date: December 21, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1b/2, open label, multicenter, safety and clinical activity study of avelumab in combination with chemotherapy as first-line treatment of adult patients with locally advanced or metastatic solid tumors. Initially, avelumab will be evaluated in combination with pemetrexed and carboplatin in patients with advanced non-squamous non-small cell lung cancer (NSCLC) (Cohort A1) and in combination with gemcitabine and cisplatin in patients with cisplatin-eligible urothelial (bladder) cancer (UC) (Cohort A2). As more information is learned about other anti-cancer immunotherapy agents, in future portions of the study, avelumab may be combined with chemotherapy and other anti-cancer immunotherapy agents in patients with these same or different tumor types.

NCT ID: NCT03315143 Terminated - Heart Failure Clinical Trials

Effect of Sotagliflozin on Cardiovascular and Renal Events in Participants With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk

SCORED
Start date: December 19, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of the study was to compare the effect of sotagliflozin to placebo on total occurrences of cardiovascular (CV) death, hospitalization for heart failure [HHF], and urgent visit for heart failure [HF] in participants with type 2 diabetes, cardiovascular risk factors, and moderate to severely impaired renal function.

NCT ID: NCT03309358 Terminated - Cystic Fibrosis Clinical Trials

A Study of the Safety and Tolerability of Inhaled SNSP113 in Healthy Subjects and Subjects With Stable Cystic Fibrosis

Start date: September 28, 2017
Phase: Phase 1
Study type: Interventional

Although Cystic Fibrosis is a complex genetic disease affecting many organs, lung disease is the primary cause of mortality. The objective of this study is to determine the safety and tolerability of SNSP113 in healthy subjects and subjects with stable cystic fibrosis.

NCT ID: NCT03303911 Terminated - Smoking Cessation Clinical Trials

A Pharmacokinetic and Pharmacodynamic Evaluation of Cytisine in Healthy Smokers

Start date: October 6, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objectives of this study are: - To evaluate the pharmacokinetic (PK) parameters during repeat dosing of 1.5 mg or 3.0 mg cytisine when administered as the commercial 25-day schedule. - To evaluate the pharmacodynamic (PD) effects (e.g., reduction in smoking) with repeat dosing of 1.5 mg or 3.0 mg cytisine when administered as the commercial 25-day schedule.

NCT ID: NCT03300362 Terminated - Influenza Clinical Trials

Improved Novel VaccIne CombinaTion InflUenza Study

INVICTUS
Start date: October 13, 2017
Phase: Phase 2
Study type: Interventional

A Phase IIb randomised, participant-blinded, placebo-controlled, multi-centre phase IIb efficacy study in 2030 volunteers aged 65 and over. The study will assess the safety and efficacy of the co-administration of a viral vectored vaccine, MVA- NP+M1, and the annual recommended licensed inactivated influenza vaccine (IIV). Within the main cohort 100 participants will be recruited to an immunology sub-cohort.

NCT ID: NCT03298113 Terminated - Clinical trials for Incontinence-associated Dermatitis

Comparative Study to Assess an Advanced Skin Protectant in the Management of Incontinence-associated Dermatitis

Start date: November 17, 2017
Phase: N/A
Study type: Interventional

The purpose of the clinical study is to assess the effects of 3M Cavilon Advanced Skin Protectant in comparison to different local IAD care regimes in hospitals (IAD: Incontinence-associated Dermatitis)