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The effectiveness of the serious game *Broodles* in improving psychosocial well-being of siblings (6-9 years old) of children with visual impairment and/or intellectual disability: A randomized controlled trial

The goal of this study is to evaluate the effectiveness of the serious game *Broodles* in improving the quality of life and psychosocial well-being of siblings (6-9 years) of children with VI and/or ID.

A randomized, participant and investigator blinded, sponsor open-label, placebo-controlled, single and multiple dose study to investigate the safety and tolerability of XXB750 in heart failure participants with reduced or mildly reduced ejection fraction (HFrEF/HFmrEF)

To evaluate the safety and tolerability of XXB750 in adult participants with chronic stable HFrEF/HFmrEF.

Dual hormone closed loop in type 1 diabetes: a randomized trial

To determine the long-term clinical effectiveness of treatment with a dual-hormone (insulin and glucagon) fully closed loop system during 12 months compared to the current most used care and to the currently most advanced technological care.…

A Phase 3 Randomized Study Comparing Teclistamab Monotherapy versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants with Relapsed or Refractory Multiple Myeloma who have Received 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Monoclonal Antibody and Lenalidomide

This study has been transitioned to CTIS with ID 2023-503444-13-00 check the CTIS register for the current data. The primary objective of this study is to compare the efficacy of teclistamab monotherapy (Arm A) with that of an investigator*s choice…

A multi-centre, randomised, double-blind, placebo-controlled, Phase 2 study to investigate efficacy, safety and tolerability of SLN360 in participants with elevated lipoprotein(a) at high risk of atherosclerotic cardiovascular disease events.

The primary objective is to evaluate the effect of SLN360 on circulating levels of Lp(a) in participants with elevated Lp(a) at high risk of ASCVD events.The secondary objectives are to:• Evaluate safety and tolerability of SLN360 in participants…

EMECLO: the Electroconvulsive therapy vs. MEdication in patients with CLOzapine-refractory symptoms trial

The main objective of this study is to investigate the feasibility of a larger single-blind, randomized trial focused on (cost) effectiveness and safety of ECT vs. aripiprazole addition in patients with schizophrenia spectrum disorders (SSD)…

A Phase 3 Randomized Study Comparing Talquetamab in Combination with Daratumumab (SC) and Pomalidomide (Tal-DP) or Talquetamab (SC) in combination with Daratumumab SC (Tal-D) versus Daratumumab SC, Pomalidomide and Dexamethasone (DPd), in Participants With Relapsed or Refractory Multiple Myeloma who Have Received at Least 1 Prior Line of Therapy

This study has been transitioned to CTIS with ID 2023-503467-41-00 check the CTIS register for the current data. The purpose of the study is to compare the efficacy of talquetamab subcutaneous(ly) (SC) in combination with daratumumab SC and…

A Phase 3, Randomized, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab in Participants with Fistulizing, Perianal Crohn*s Disease

This study has been transitioned to CTIS with ID 2023-504740-33-00 check the CTIS register for the current data. Objectives• To evaluate the clinical efficacy of guselkumab in fistulizing, perianal Crohn*s disease• To assess the overall safety of…

A Randomized, Open-Label, Phase 3 Study to Evaluate Zimberelimab and Domvanalimab in Combination with Chemotherapy Versus Pembrolizumab With Chemotherapy for the First-Line Treatment of Patients With Metastatic Non-Small Cell Lung Cancer With No Epidermal Growth Factor Receptor or Anaplastic Lymphoma Kinase Genomic Tumor Aberrations

This study has been transitioned to CTIS with ID 2023-509825-38-00 check the CTIS register for the current data. To compare the effect of ZIM and DOM in combination with chemotherapy relative to PEMBRO in combination with chemotherapy (Group A…

A randomized, placebo-controlled, double-blind, parallel-group Phase 2a exploratory study with placebo run-in to investigate PK/PD effects, safety, tolerability and pharmacokinetics of REM0046127 oral suspension compared with placebo in subjects with mild to moderate Alzheimer's disease

• To assess the tolerability and safety of the investigational medicinal product

A Randomized, Double-Blind, Multicenter, Phase 2 Study of Retifanlimab in Combination With INCAGN02385 (Anti-LAG-3) and INCAGN02390 (Anti-TIM-3) as First-Line Treatment in Participants With PD-L1-Positive (CPS >= 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

To determine the efficacy of the combinations of retifanlimab + INCAGN02385 (TG2) and retifanlimab + INCAGN02385 + INCAGN02390 (TG3) compared with retifanlimab alone (TG1) in the overall study population.

A Phase 1 Clinical Trial to Determine the Safety, Pharmacokinetics and Pharmacodynamics of Intravenous GH002 in Healthy Volunteers

Primary objectives: • To determine the safety and tolerability of a single administration and single-day IDR of intravenous GH002.• To determine the pharmacokinetics (PK) of 5-MeO-DMT in healthy volunteers following a single administration and…

A PROSPECTIVE, RANDOMIZED, OPEN-LABEL PHASE 2 STUDY TO EVALUATE THE SUPERIORITY OF INOTUZUMAB OZOGAMICIN MONOTHERAPY VERSUS ALLR3 FOR INDUCTION TREATMENT OF CHILDHOOD HIGH RISK FIRST RELAPSE B-CELL PRECURSOR ACUTE LYMPHOBLASTIC LEUKAEMIA

This study has been transitioned to CTIS with ID 2023-509810-13-00 check the CTIS register for the current data. Primary Objectives Efficacy: To demonstrate the superiority of InO monotherapy vs ALLR3 induction in paediatric participants between 1…

A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib + Docetaxel Versus Placebo + Docetaxel as Treatment for Patients with Metastatic Castration Resistant Prostate Cancer (mCRPC)

This study has been transitioned to CTIS with ID 2023-504996-26-00 check the CTIS register for the current data. The primary objective of this study is to assess the efficacy, measured by OS, of capivasertib + docetaxel versus placebo + docetaxel,…

SUPERvised three-month exercise program in MEN with Prostate cAncer Receiving androgen-deprivaTioN thERapy

To examine the impact of a supervised training program on disease-related quality of life and physical fitness in patient with advanced prostate cancer compared to usual care.

A randomized, double-blind, placebo-controlled, Phase 2b trial with an open-label extension to determine the safety and efficacy of GH001 in patients with treatment-resistant depression.

To determine the efficacy of a single day individualized dosing regimen (IDR) of GH001 compared with placebo in improving depressive symptoms as assessed by MADRS in patients with treatment-resistant depression (TRD) at the end of the 7-day double-…

A PHASE I-III, MULTICENTER STUDY
EVALUATING THE EFFICACY AND SAFETY OF
MULTIPLE THERAPIES IN COHORTS OF
PATIENTS SELECTED ACCORDING TO
BIOMARKER STATUS, WITH LOCALLY
ADVANCED, UNRESECTABLE, STAGE III
NON-SMALL CELL LUNG CANCER

This study has been transitioned to CTIS with ID 2023-503920-14-00 check the CTIS register for the current data. The overall objectives of this study are to evaluate the efficacy and safety of multiple therapies in patients with locally advanced,…

A comparison between Qutenza and duloxetine for the treatment of painful chemotherapy-induced peripheral neuropathy (QULOX): a pragmatic randomized controlled trial

The primary objective is to determine whether in patients with CIPN pain, treatment with Qutenza has the same effect as treatment with duloxetine

REDUCE PMR: Rituximab Effect on Decreasing glUcoCorticoid Exposition in newly diagnosed PolyMyalgia Rheumatica

This study has been transitioned to CTIS with ID 2024-513544-28-00 check the CTIS register for the current data. The main objective is to study the efficacy of treatment with RTX in patients with newly diagnosed PMR compared to placebo.

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, PARALLEL STUDY TO ASSESS THE EFFICACY, SAFETY, TOLERABILITY, PK, AND BIOMARKER EFFECTS OF PTC857 IN ADULT SUBJECTS WITH AMYOTROPHIC LATERAL SCLEROSIS (CARDINALS)

This study has been transitioned to CTIS with ID 2023-510317-26-00 check the CTIS register for the current data. To evaluate the efficacy of PTC857 in reducing disease progression in subjects with amyotrophic lateral sclerosis (ALS)