34 completed, 12 terminated, 11 recruiting, 7 not yet recruiting. 20 Not applicable, 18 Phase 2, 12 Phase 1, 2 Phase 3, 2 Phase 4.
Follow Craniosynostoses: new trials by email Literature Review of Craniosynostoses trials Research Report on Craniosynostoses
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Multimodal Mechanical, Tissue, Architectural, and Histological Evaluation of the Bone and Sutures of the Parietal Bone in an Infant With Craniosynostosis. Biological sample, bones sample and questionaires. - Craniostenosis | Not yet recruiting | Hospices Civils de Lyon | 80 | 2026-11-01 | 2026-10-26 | |
| Effects of Tummy Time Associated With Therapeutic Positioning in Premature Newborns With Cranial Asymmetry Tummy Time Protocol - Premature Newborns, Cranial Asymmetry | Not applicable | Not yet recruiting | Hospital de Clinicas de Porto Alegre | 300 | 2026-10-01 | 2026-09-18 |
| Frontal Reconstruction Without Orbital Advancement for Moderate Metopic Craniosynostosis Frontal vault remodelling without orbital advancement - Metopic Craniosynostosis, Craniosynostosis | Not applicable | Not yet recruiting | Assiut University | 15 | 2026-10-01 | 2026-09-23 |
| Futibatinib (TAS-120) in Patients With Advanced Biliary Tract Cancer Futibatinib, Zimberelimab, Durvalumab - Biliary Tract Cancer | Phase 3 | Recruiting | Taiho Pharmaceutical Co., Ltd. | 784 | 2026-06-24 | 2026-07-17 |
| ASO Treatment for Syndromic Craniosynostoses Design of patient specific ASO - Craniosynostoses, Crouzon Syndrome | Recruiting | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | 12 | 2026-04-20 | 2026-09-08 | |
| A Phase 1b/2 Study of the Safety and Efficacy of the Monoclonal Antibody OM-RCA-01 in Patients With Metastatic Tumors Expressing Fibroblast Growth Factor Receptor 1 humanized monoclonal anti-FGFR1 antibody OM-RCA-01 - Renal Cell Carcinoma Metastatic, Prostate Cancer Metastatic | Phase 1 / Phase 2 | Recruiting | Kidney Cancer Research Bureau | 64 | 2025-12-02 | 2026-11-10 |
| Effects of Corrective Helmet Therapy on Cervical Motion and Thermoregulation in Children With Positional Deformities cranial helmet therapy - observational - Plagiocephaly, Nonsynostotic, Brachycephaly | Not yet recruiting | Wroclaw University of Health and Sport Sciences | 270 | 2025-09-01 | 2025-10-01 | |
| Ocular Characteristics in Patients With Craniosynostosis Craniosynostosis, Strabismus | Recruiting | Centre Hospitalier Universitaire, Amiens | 65 | 2025-04-04 | 2026-02-12 | |
| Cranial Remolding Orthosis Registry MyCRO Band, Traditional CRO - Plagiocephaly, Brachycephaly | Not yet recruiting | Otto Bock HealthCare LP | 500 | 2025-04-01 | 2025-01-07 | |
| EPBONF : Evaluation of the Safety and Effectiveness of a Medical Device Aimed at Guiding Orbito-naso-frontal Band Surgery, for the Treatment of Craniostenoses BONFIX system - Craniosynostoses | Not applicable | Not yet recruiting | Centre Hospitalier Universitaire de Besancon | 5 | 2024-12-01 | 2024-04-15 |
| Functionalized Bioink Delivering Biomolecules for the Treatment of Craniofacial Diseases multiomic profiling - Craniofacial Defects, Subtle, Skull Defect | Unknown | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | 180 | 2024-10-07 | 2025-03-14 | |
| Driving Pressure-guided Tidal Volume Ventilation in the Acute Respiratory Distress Syndrome Tidal volume customization in the acute respiratory distress syndrome - Acute Respiratory Distress Syndrome ARDS | Not applicable | Not yet recruiting | Assistance Publique - Hôpitaux de Paris | 750 | 2024-09-01 | 2024-03-26 |
| Monitoring System for Cranial Orthoses Cranial Remolding Orthosis - Plagiocephaly, Brachycephaly | Completed | University of Texas Southwestern Medical Center | 12 | 2024-08-19 | 2026-07-22 | |
| Pleth Variability Index Monitoring in Pediatric Craniosynostosis Surgery Craniosynostosis | Recruiting | Muzaffer GENCER | 30 | 2024-08-01 | 2026-06-18 | |
| Hemodynamic Monitoring During Craniosynostosis Surgery: Comparing Traditional and Newer Technology Monitors (CRASY-PRAM) Intraoperative monitoring - Craniosynostoses, Hypovolemia | Recruiting | IRCCS Azienda Ospedaliero-Universitaria di Bologna | 30 | 2023-12-13 | 2025-10-03 | |
| Safety and Anti-Tumor Activity of TYRA-200 in Advanced Cholangiocarcinoma With Activating FGFR2 Gene Alterations Phase 1 Part A - dose escalation TYRA-200 taken once daily by mouth in 28-day cycles, Phase 1 Part B - dose expansion TYRA-200 taken once daily by mouth in 28-day cycles - Locally Advanced Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma | Phase 1 | Active not recruiting | Tyra Biosciences, Inc | 40 | 2023-11-22 | 2026-10-14 |
| Effectiveness of Repositioning and Cranial Remolding in Infants With Cranial Deformation Repositioning Therapy, Cranial Remolding Orthosis - Deformational Plagiocephaly, Deformational Posterior Plagiocephaly | Not applicable | Recruiting | University of Texas Southwestern Medical Center | 65 | 2023-05-23 | 2026-08-31 |
| A Study of Erdafitinib Intravesical Delivery System in Japanese Participants With Bladder Cancer Erdafitinib Intravesical Delivery System - Urinary Bladder Neoplasms, Receptors, Fibroblast Growth Factor | Phase 1 | Completed | Janssen Pharmaceutical K.K. | 5 | 2023-03-03 | 2026-11-03 |
| Influence of General Anesthesia on the Dynamic Changes in Brain Damage Markers During and After Craniosynostosis Operations in Infancy Craniosynostosis, Anesthesia | Enrolling by invitation | Comenius University | 45 | 2022-10-01 | 2023-06-23 | |
| Craniosynostosis :Surgical Treatment Modalities and Outcome Craniostnostosis surgery - Craniosynostoses | Not applicable | Unknown | Assiut University | 24 | 2022-09-01 | 2022-08-22 |
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Acrocephalosyndactylia (33) · Neoplasms (6) · Cholangiocarcinoma (5) · Plagiocephaly (5) · Plagiocephaly, Nonsynostotic (5) · Breast Neoplasms (4) · Carcinoma, Non-Small-Cell Lung (4) · Carcinoma, Transitional Cell (4) · Hemorrhage (3) · Neoplasm Metastasis (3) · Urinary Bladder Neoplasms (3) · Cleft Lip (2) · Esophageal Neoplasms (2) · Head and Neck Neoplasms (2)
Bone Diseases (81) · Bone Diseases, Developmental (81) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (81) · Craniofacial Abnormalities (81) · Dysostoses (81) · Musculoskeletal Abnormalities (81) · Musculoskeletal Diseases (81) · Congenital Abnormalities (80) · Synostosis (79) · Limb Deformities, Congenital (34) · Syndactyly (33) · Neoplasms (19) · Neoplasms by Site (16) · Pathological Conditions, Signs and Symptoms (16)
pemigatinib (6) · Tranexamic Acid (4) · infigratinib (3) · Aminocaproic Acid (2) · Gemcitabine (2) · Rogaratinib (2) · Saline Solution (2) · derazantinib (2) · erdafitinib (2) · pembrolizumab (2) · Alpelisib (1) · Biopsy (1) · Blood Specimen Collection (1) · Carboplatin (1) · Cisplatin (1)
Incyte Corporation (7) · National Human Genome Research Institute (NHGRI) (4) · Fondazione Policlinico Universitario Agostino Gemelli IRCCS (3) · Hospices Civils de Lyon (3) · Janssen Research & Development, LLC (3) · Assistance Publique - Hôpitaux de Paris (2) · Assiut University (2) · Basilea Pharmaceutica (2) · Boston Children's Hospital (2) · Eisai Co., Ltd. (2) · Teresa Helsten, MD (2) · University of Pittsburgh (2) · University of Texas Southwestern Medical Center (2) · Acıbadem Atunizade Hospital (1) · Bayer (1)
United States (37) · France (19) · Italy (13) · Japan (11) · Spain (11) · Germany (10) · United Kingdom (9) · South Korea (8) · Belgium (7) · Switzerland (5) · Turkey (Türkiye) (5) · Australia (4) · Brazil (4) · Canada (4) · Israel (4)
Ekaterine Asatiani, MD (2) · Teresa Helsten, MD (2) · Ahmed El Shanawany, M.D., Ph.D. (1) · Alfredo Addeo, MD (1) · Barbara B Biesecker (1) · David F Bauer, MD, MPH (1) · David YC Chan, MBBS, FRCS (1) · Dorothea Daentzer, Prof.Dr.med. (1) · Doug Warner (1) · Ethylin Wang Jabs, MD (1) · Eylem Ocal, MD (1) · Faizi Siddiqu, MD (1) · Farrag Farrag, M.D., Ph.D. (1)
PMID 16001919, PMID 16428493, PMID 16526927, PMID 17186250, PMID 17343269, PMID 17440368, PMID 17760493, PMID 17899471, PMID 17945777, PMID 18297062, PMID 18459881, PMID 18635960, PMID 18797362, PMID 20644427, PMID 20683987, PMID 20815729, PMID 20818389, PMID 21204214, PMID 21897172, PMID 22312170, PMID 22502768, PMID 22929249, PMID 23851801, PMID 24491036, PMID 24841516, PMID 25853124, PMID 25909093, PMID 26267434, PMID 26324363, PMID 26910679, PMID 27002187, PMID 27606930, PMID 27870340, PMID 28027242, PMID 28790902, PMID 28941128, PMID 29225392, PMID 29280877, PMID 29540505, PMID 29574839, PMID 30048539, PMID 30228104, PMID 30234486, PMID 30558321, PMID 30651579, PMID 30680710, PMID 31006064, PMID 31063132, PMID 31064775, PMID 31088831
2016 (3), 2019 (3), 2017 (1), 2018 (1), P01HD078233 (1), R01DE013813 (1), R42HD081712 (1)