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Efficacy of repetitive transcranial magnetic stimulation in patients with medication-resistant bipolar depression. A multicenter, randomized, double-blind, sham-controlled study

Objective: We want to determine the effectiveness of rTMS in patients with bipolar depression who did not respond to two or more adequately dosed medication trials, using an adequately powered pragmatic RCT. We hypothesize that active rTMS, compared…

MyopiaX Treatment for the Reduction of Myopia Progression in Children and Adolescents: Safety and Efficacy Investigation

Primary objectiveTo evaluate the effects of treatment with MyopiaX on the rate of myopia progression in children and adolescents as reflected in spherical equivalent refraction and axial length changes at 6months relative to baseline.Secondary…

A Phase 3 Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Daily Subcutaneous Injections of Elamipretide in Subjects with Primary Mitochondrial Disease Resulting from Pathogenic Nuclear DNA Mutations (nPMD)

The primary objective of this study is to evaluate the effect of single daily SC administration of elamipretide for 48 weeks on the distance walked (in meters) on the 6-minute walk test.The secondary objectives of this study are:- To evaluate the…

Prospective clinical trial to evaluate the efficacy of acetazolamide for the treatment of cystoid macular edema in inherited retinal dystrophies: the CAR trial

Our study objective is to evaluate the efficacy of acetazolamide for the treatment of cystoid macula edema in inherited retinal dystrophies in anticipation of future clinical trials.

A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Patients 6 to 17 Years of Age with Episodic Migraine - the REBUILD-1

This study has been transitioned to CTIS with ID 2023-505836-36-00 check the CTIS register for the current data. Main Objective:To demonstrate the superiority of galcanezumab versus placebo in the prevention of migraine in (at least) 1 of the…

Deep versus moderate neuromuscular blockade during total hip replacement surgery to improve postoperative quality of recovery and immune function: a randomized controlled study

The main objective of this study is to assess the potential effect of deep neuromuscular blockade on the quality of recovery after total hip replacement surgery under general anesthesia. Secondary aims are to establish the relationship between the…

A Phase 3, Randomized, Open-Label Study of Imlunestrant, Investigator*s Choice of Endocrine Therapy, and Imlunestrant plus Abemaciclib in Patients with Estrogen Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated with Endocrine Therapy

This study has been transitioned to CTIS with ID 2023-506786-63-00 check the CTIS register for the current data. Main objective:•To compare the progression-free survival of imlunestrant (Arm A) to the standard comparator of Investigator's…

Phase 2, Multicenter, Randomized, Parallel, 3-arm, Placebo-controlled Study to Assess Efficacy and Safety of CDR132L in Patients with Reduced Left Ventricular Ejection Fraction (<= 45%) After Myocardial Infarction (HF-REVERT)

This study has been transitioned to CTIS with ID 2023-507569-24-00 check the CTIS register for the current data. This is a Phase 2, multicenter, randomized, parallel, 3-arm, placebo-controlled study to assess theefficacy and safety of CDR132L in…

A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Adolescent Patients 12 to 17 Years of Age with Chronic Migraine - the REBUILD-2

This study has been transitioned to CTIS with ID 2023-505835-11-00 check the CTIS register for the current data. PrimaryTo demonstrate the superiority of galcanezumab versus placebo in the prevention of migraine in an adolescent population (12 to 17…

Efficacy and safety of NNC6019-0001 at two dose levels in participants with
transthyretin amyloid cardiomyopathy (ATTR CM)

This study has been transitioned to CTIS with ID 2023-506824-96-00 check the CTIS register for the current data. • safety and tolerability from baseline to week 64 in participants with hATTR or wtATTR cardiomyopathyPrimary • To compare the effect of…

Phase 3, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Apitegromab (SRK-015) in Patients with Later-Onset Spinal Muscular Atrophy Receiving Background Nusinersen or Risdiplam Therapy

Primary-Assess the efficacy of apitegromab compared with placebo using the HFMSE in patients 2 through 12 years oldKey secondary-Assess the efficacy of apitegromab compared with placebo based on the number of patients with clinical improvement in…

Effect of protein supplementation on fat free mass preservation after bariatric surgery, a randomized double-blind placebo-controlled trial.

The main aim of this study is to assess whether protein supplementation could prevent excessive fat free mass loss during the first year after bariatric surgery.

IcoSApent ethyL to slow down aortic VAlve stenosis proGrEssion

This study has been transitioned to CTIS with ID 2024-517342-33-01 check the CTIS register for the current data. The primary objective is:• to study the effect of icosapent ethyl on progression of aortic valve calcification.The secondary objectives…

The immunomodulatory effect of sugammadex after total hip replacement surgery under neuraxial anaesthesia: a pilot study

The overall objective of this study is to investigate the potential immunomodulatory effect of sugammadex as seen in previous ex vivo experiments. Specified, the main objective is to investigate the effect of administration of sugammadex without…

Double-blind, randomised, placebo-controlled, dose-finding phase IIb trial to evaluate the efficacy, safety, and tolerability of a 12-week-treatment with Naronapride in adult participants with at least moderate idiopathic or diabetic gastroparesis

This study has been transitioned to CTIS with ID 2023-510195-31-00 check the CTIS register for the current data. The study aim is to examine different doses of Naronapride film-coated tablets (for oral intake) versus placebo in patients with…

A Phase 3b/4 Randomized, Blinded, Treat-to-Target and Dose-Flexibility Study of Upadacitinib in Adult Subjects with Moderate to Severe Atopic Dermatitis

This study has been transitioned to CTIS with ID 2023-504869-23-00 check the CTIS register for the current data. 1. Sub-Study 1 (SS1): The primary study objective for SS1 is to evaluate the efficacy and safety of dose escalation to upadacitinib 30…

Exploring the effects of a combined exercise programme on pain and fatigue outcomes in patients with systemic sclerosis: A large multi-centre randomised controlled trial

To assess the effect of a previously-established, supervised 12-week combined (aerobic and resistance training) exercise programme on pain and fatigue as compared to no exercise.

Obicetrapib on Top of Maximum Tolerated Lipid-ModifyingTherapies (BROADWAY): A Placebo-Controlled, Double-Blind, Randomized Phase 3 Study to Evaluate the Effect of 10 mg Obicetrapib in Participants With Underlying HeFH and/or Atherosclerotic Cardiovascular Disease (ASCVD) Who are Not Adequately Controlled by Their Lipid-Modifying Therapies;Protocol v6.0

Synopsis, page 4-5OBJECTIVES:The primary objective of this study is to evaluate the effect of obicetrapib on LDL-C levels at Day 84.The secondary objectives of this study include the following:• To evaluate the effect of obicetrapib on LDL-C levels…

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel
Design, Prospective, 52-Week, Phase 2 Clinical Study to Evaluate the Safety and Efficacy of GV1001 Administered Subcutaneously for the Treatment of Mild to Moderate Alzheimer*s Disease

This study has been transitioned to CTIS with ID 2024-511610-20-00 check the CTIS register for the current data. Cognitive and functional abilities will be evaluated using psychometric scales (ie, cognitive subscale of the Alzheimer*s Disease…

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Safety and Efficacy of CORT113176 (Dazucorilant) in Patients with Amyotrophic Lateral Sclerosis (DAZALS)

This study has been transitioned to CTIS with ID 2024-514082-19-00 check the CTIS register for the current data. The aim of this phase 2 study is to investigate the safety and efficacy of dazucorilant in the target ALS patient population.