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NCT ID: NCT03917719 Terminated - Clinical trials for Duchenne Muscular Dystrophy

An Open-Label Extension Study of Edasalonexent in Boys With Duchenne Muscular Dystrophy

GalaxyDMD
Start date: March 14, 2019
Phase: Phase 3
Study type: Interventional

The GalaxyDMD study is a global Phase 3, open-label, treatment extension study to evaluate the safety, tolerability, and durability of effect in long-term dosing of edasalonexent in pediatric patients with a genetically confirmed diagnosis of DMD. Patients who completed CAT-1004-201 or CAT-1004-301 or siblings of these boys from 4-12 years of age (up to 13th birthday) will be enrolled. Edasalonexent is an orally administered small molecule that inhibits NF-kB, which is a key link between loss of dystrophin and disease pathology and plays a fundamental role in the initiation and progression of skeletal and cardiac muscle disease in DMD.

NCT ID: NCT03917498 Active, not recruiting - Breast Cancer Clinical Trials

Single Pre-Operative Radiation Therapy - With Delayed Surgery for Low Risk Breast Cancer

SPORT-DS
Start date: April 1, 2018
Phase: N/A
Study type: Interventional

To study a single dose of preoperative partial radiotherapy to a low-risk breast tumour. The radiotherapy will be goven 3 months before surgery.

NCT ID: NCT03917082 Active, not recruiting - Clinical trials for Breast Cancer Female

Limited Adjuvant Endocrine Therapy for Low Risk Breast Cancer

LALEAST
Start date: September 23, 2019
Phase: Phase 2
Study type: Interventional

Phase II trial of 2 years of standard adjuvant endocrine therapy after low risk hormone receptor positive, HER2 negative, node negative breast cancer in women older than 50 at diagnosis. The study hypothesis is that reducing adjuvant endocrine therapy from 5 to 2 years in a population with low risk of breast cancer; as determined by histopathologic criteria and confirmed by low risk genomic analysis using Prosigna®; will be safe and acceptable to this population, and will not compromise the expected excellent breast cancer specific outcomes for this population.

NCT ID: NCT03916081 Completed - Atopic Dermatitis Clinical Trials

Safety and Efficacy of ARQ-151 Cream in Adolescents and Adults With Atopic Dermatitis

Start date: May 31, 2019
Phase: Phase 2
Study type: Interventional

The study will assess the safety, pharmacokinetics (PK), and efficacy of different doses of roflumilast (ARQ-151) cream (0.05% and 0.15%) vs placebo applied once daily (QD) for 28 days by adolescents and adults with atopic dermatitis.

NCT ID: NCT03915613 Recruiting - Clinical trials for Major Depressive Disorder

Brain Insulin Resistance in Mood Disorders

Start date: October 6, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The overarching aim of the study is to determine the role of insulin signaling on the neurobiological substrates subserving anhedonia within individuals with mood disorders (i.e., Bipolar Disorder (BD) and Major Depressive Disorder (MDD)). Specific aims include: 1. Molecular: Assessment of components of the insulin cascade, as well as of anhedonia and reward-related processes, using a proteomics and gene expression approach; 2. Physiology: Measurement of peripheral sensitivity to insulin and metabolic correlates, including body mass index and dyslipidemia; 3. Neural Circuits: Evaluation of the insulin sensitivity of prefrontal (e.g. prefrontal cortex) and striatal (e.g. nucleus accumbens, ventral tegmental area) networks in the resting-state and during an effort-based decision making test, using acutely administered intranasal insulin and functional magnetic resonance imaging (fMRI); 4. Behavioral: Measurement of willingness to make effort for rewards, as well as of other components of reward response and anhedonia, using validated behavioral tasks and clinical scales (e.g. Snaith-Hamilton Pleasure Scale - SHPS). This initiative represents a proof-of-concept study that insulin is important to anhedonia, neurocognitive functioning, and behavioural deficits in MDD, representing a novel and safe therapeutic avenue.

NCT ID: NCT03915535 Terminated - Healthy Athletes Clinical Trials

Impact of Fish Oil Monoglycerides on the Modulation of Mitochondrial Functions and Lactate Threshold

Start date: September 19, 2019
Phase: Phase 4
Study type: Interventional

he objective of this study is to compare the effects two different formulations of fish oil monoglycerides on the mitochondrial functions and on the lactate threshold of athletes during a high intensity exercise. Twenty four (24) subjects will be enrolled in the study and followed for a period of 90 days. A first visit will capture all the baseline parameters and will be followed by two subsequent visits (at day 45 and at day 90) where the same measurements will be done. The subjects will be divided in two parallel groups. Subjects of group A will receive a constant daily dose of 4,3g eicosapentaenoic acid (EPA) + Docosahexaenoic acid (DHA) whereas subjects of group B will receive a constant daily dose of 4,4g of EPA only. Subjects will be treated from day 1 to day 90 without interruption or modification to their regimen.

NCT ID: NCT03915496 Completed - Atopic Dermatitis Clinical Trials

Study Evaluating the Mechanism of Action of PF-04965842 Monotherapy for Moderate-to-severe Atopic Dermatitis

JADE MOA
Start date: June 18, 2020
Phase: Phase 2
Study type: Interventional

B7451037 is a randomized, double-blind, placebo-controlled, parallel-group, Phase 2a study to investigate the mechanism of action of PF-04965842 by correlating efficacy outcomes with changes from baseline in key skin and blood biomarkers in adult participants at least 18 years of age with moderate-to-severe atopic dermatitis. Participants will be screened within 28 days prior to the first dose of study intervention to confirm eligibility. A total of approximately 51 participants will be randomized in a 1:1:1 ratio to receive PF-04965842 200 mg once daily (QD), PF004965842 100 mg QD, or matching placebo QD for 12 weeks. At the end of the 12-week study treatment, qualified participants will have the option to enter the long-term extension study B7451015 (NCT03422822). Participants discontinuing early from this study will undergo a 4-week off-treatment follow-up period.

NCT ID: NCT03915340 Completed - Bioequivalence Clinical Trials

Bioequivalence Study of Two Formulations of Propafenone 300 mg Film-coated Tablets in Healthy Adult Volunteers After a Single Oral Dose Administration Under Fasting Conditions

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

This bioequivalence study will be conducted in healthy male and female volunteers in order to determine the bioequivalence of two different formulations of propafenone after a single oral dose administration under fasting conditions.

NCT ID: NCT03915184 Active, not recruiting - Multiple Myeloma Clinical Trials

Clinical Trial to Evaluate Zevor-cel (CT053) in Patients With Relapsed and/or Refractory Multiple Myeloma (LUMMICAR STUDY 2)

Start date: September 25, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

A phase 1b/2, open label, multi-center, Clinical Study of Chimeric Antigen Receptor T Cells targeting BCMA in patients with relapsed and or refractory multiple myeloma.

NCT ID: NCT03915067 Completed - Platysma Prominence Clinical Trials

BOTOX® for the Treatment of Platysma Prominence

Start date: April 23, 2019
Phase: Phase 2
Study type: Interventional

To assess the efficacy and safety of BOTOX® in adults with moderate to severe platysma prominence.