Clinical trials: sponsored by Jazz Pharmaceuticals
Focal Seizures
A Study to Evaluate the Efficacy and Safety of Cannabidiol Oral Solution (CBD-OS [GWP42003-P, JZP926]) for the Treatment of Focal-Onset Seizures
Cannabidiol oral solution (CBD-OS) is approved in the US for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or Tuberous sclerosis complex (TSC) in patients 1 year of age and older.
- Trial name
- NCT07233239
- Testing
- CBD-OS
- Where
- 24 sites in United States
- Volunteers
- 100 people
- Sponsor
- Jazz Pharmaceuticals
Esophageal Cancer, GastroEsophageal Cancer
Zanidatamab Outcomes and Lived Experiences in Advanced HER2+ GEA
The purpose of this study is to collect real-world data to describe the effectiveness and tolerability of first line (1L) zanidatamab-containing therapies and describe the subsequent lines of treatment in participants with…
- Conditions
- Esophageal Cancer, GastroEsophageal Cancer, Gastroesophageal-junction Cancer, HER2-positive Gastric Cancer
- Trial name
- ZOLA (NCT07780968)
- Testing
- Zanidatamab
- Where
- 2 sites in United States
- Volunteers
- 300 people
- Sponsor
- Jazz Pharmaceuticals
Healthy Participants
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of JZP047 in Healthy Participants
This is a Phase 1, double-blind, sponsor-unblinded, randomized, placebo-controlled study designed to characterize the safety, tolerability, and PK of JZP047 in healthy participants following single-ascending doses of study…
- Trial name
- NCT07377539
- Testing
- JZP047
- Where
- United States
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- Jazz Pharmaceuticals
Central Nervous System Neoplasms, Glioblastoma
Phase I Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms
The primary objective of this Phase 1, open-label, dose-escalation, and exploratory study is to evaluate the safety and tolerability profile (establish the maximum-tolerated dose) and evaluate the occurrence of dose-limiting…
- Conditions
- Central Nervous System Neoplasms, Glioblastoma, Gliosarcoma, Adult, Anaplastic Oligodendroglioma
- Trial name
- NCT04541082
- Testing
- ONC206
- Where
- United States
- Volunteers
- 102 people
- Sponsor
- Jazz Pharmaceuticals
Lennox-Gastaut Syndrome
A Study to Investigate the Effect of Gradual Titration to Optimize Cannabidiol Treatment in Adults With LGS
This is a Phase 3b/Phase 4 study. The purpose of this study is to learn more about the efficacy of using CBD-OS as an add-on therapy for the treatment of LGS in adults.
- Trial name
- EpiGOAL (NCT07728097)
- Testing
- Cannabidiol Oral Solution
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- Jazz Pharmaceuticals
Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, H3 K27M-Mutant
Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication 2.0
The BIOMEDE 2.0 study is the second stage of the BIOMEDE multi-arm, multistage rolling programme (adaptive platform protocol). It is a multicenter, randomized, open-label, controlled phase-3 trial evaluating efficacy of ONC201 in…
- Conditions
- Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, H3 K27M-Mutant, Diffuse Midline Glioma, H3K27-altered
- Trial name
- BIOMEDE 2 (NCT05476939)
- Testing
- Everolimus, ONC201, Radiotherapy
- Where
- 56 sites in Belgium, Denmark and 6 more
- Volunteers
- 433 people
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
Gastric Neoplasms, Gastroesophageal Adenocarcinoma
A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers
This study is being done to find out if zanidatamab, when given with chemotherapy plus or minus tislelizumab, is safe and works better than trastuzumab given with chemotherapy.
- Conditions
- Gastric Neoplasms, Gastroesophageal Adenocarcinoma, Esophageal Adenocarcinoma
- Trial name
- HERIZON-GEA-01 (NCT05152147)
- Testing
- Zanidatamab, Tislelizumab, Trastuzumab
- Where
- 227 sites in Argentina, Australia and 31 more
- Volunteers
- 920 people
- Sponsor
- Jazz Pharmaceuticals
Glioblastoma, Brain Tumor
ARISTOCRAT: Blinded Trial of Temozolomide +/- Cannabinoids
ARISTOCRAT is a phase II, multi-centre, double-blind, placebo-controlled, randomised trial to compare the cannabinoid Nabiximols with placebo in patients with recurrent MGMT methylated glioblastoma (GBM) treated with temozolomide…
- Conditions
- Glioblastoma, Brain Tumor, Cannabis, Brain Tumor, Recurrent
- Trial name
- ARISTOCRAT (NCT05629702)
- Testing
- Nabiximols, Temozolomide
- Where
- 17 sites in United Kingdom
- Volunteers
- 122 people
- Sponsor
- University of Birmingham
Small Cell Lung Cancer ( SCLC ), Transformed Small Cell Lung Cancer
Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer
This open-label, Phase I/II trial is studying the safety and effectiveness of an experimental drug combination, lurbinectedin with osimertinib, against a rare type of cancer known as transformed small cell lung cancer (SCLC).
- Trial name
- LOTS (NCT07153055)
- Testing
- Lurbinectedin, Osimertinib
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Misty Shields
Myeloid Neoplasm
Study of CPX-351 (VYXEOS) in Individuals < 22 Years With Secondary Myeloid Neoplasms
The purpose of this study is to learn the effects of treatment with an investigational drug, CPX-351 in patients with secondary myeloid neoplasms (SMNs).
- Trial name
- NCT05656248
- Testing
- CPX-351, MHA, Allogeneic Hematopoietic Stem Cell Transplantation
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- St. Jude Children's Research Hospital
Narcolepsy, Idiopathic Hypersomnia
A Study Evaluating the Efficacy and Safety of Xywav Expanded Dosing vs Placebo in Participants With Narcolepsy or IH
The purpose of this study is to evaluate the efficacy and safety of expanded Xywav dosing regimens in adult participants with narcolepsy or idiopathic hypersomnia (IH).
- Trial name
- XYRISE (NCT07625280)
- Testing
- Xywav
- Where
- 15 sites in United States
- Volunteers
- 120 people
- Sponsor
- Jazz Pharmaceuticals
Clinical High Risk for Psychosis (CHR), Clinical High Risk for Psychosis
Stratification and Treatment in Early Psychosis Study - PROMOTE
The purpose of this trial is: To investigate whether cannabidiol (CBD), compared to placebo, can reduce the severity of attenuated psychotic symptoms in individuals at clinical high risk for psychosis.
- Conditions
- Clinical High Risk for Psychosis (CHR), Clinical High Risk for Psychosis, Clinical High Risk for Developing Psychosis
- Trial name
- STEP-PROMOTE (NCT07434973)
- Testing
- Cannabidiol (CBD)
- Where
- 19 sites in Austria, Canada and 8 more
- Volunteers
- 586 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Juvenile Myoclonic Epilepsy
A Study to Evaluate the Safety and Efficacy of JZP926 Capsule for the Treatment of Juvenile Myoclonic Epilepsy
This study is being conducted to evaluate the safety and efficacy of JZP926 capsule in participants with Juvenile Myoclonic Epilepsy (JME).
- Trial name
- NCT07723963
- Testing
- JZP926 capsule
- Where
- 20 sites in United States
- Volunteers
- 260 people
- Sponsor
- Jazz Pharmaceuticals
Gastroesophageal Adenocarcinoma
AACR Adaptive Biomarker-Driven Organ Preservation Trial in Gastroesophageal Adenocarcinomas
This study will test a new personalized treatment approach for patients with stomach or esophageal cancer. It will take place in two stages and aims to find the best combination of chemotherapy, immunotherapy, and targeted drugs…
- Trial name
- AACR-ADOPT-GEA (NCT07290985)
- Testing
- Tislelizumab, Leucovorin, Oxaliplatin
- Where
- 4 sites in United States, Canada
- Volunteers
- 242 people
- Sponsor
- American Association for Cancer Research
Maternal Complications, Pregnancy Complication
Pregnancy Surveillance Program of Patients Exposed to Epidiolex/Epidyolex During Pregnancy
The purpose of this study is to evaluate pregnancy-related health outcomes in participants who are exposed to Epidiolex/Epidyolex during pregnancy and their infant up to 12 months of life.
- Conditions
- Maternal Complications, Pregnancy Complication, Birth Outcomes, Adverse, Pregnancy
- Trial name
- NCT06113237
- Testing
- Epidiolex
- Where
- 3 sites in United States, Germany and 1 more
- Volunteers
- 50 people
- Sponsor
- Jazz Pharmaceuticals
Sturge - Weber Syndrome (SWS)
Epidiolex Trial for Presymptomatic Treatment of Sturge-Weber Syndrome
Patients with Sturge-Weber syndrome (SWS) are frequently affected by seizures, and seizures are associated with poorer neurological outcomes. To date there is no established means of predicting or preventing seizure onset.
- Trial name
- Epi-Pre (NCT07778810)
- Testing
- Epidiolex 100 mg/mL Oral Solution
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Johns Hopkins University
Advanced Pheochromocytoma and Paraganglioma, PCPG
Study of ONC206 (JZP3507) in Advanced Pheochromocytoma and Paraganglioma
This is a two-stage Phase 2 trial evaluating the efficacy and safety of ONC206 in participants with Pheochromocytoma and Paraganglioma (PCPG).
- Trial name
- NCT07282587
- Testing
- ONC206, ONC206: Dose 1, ONC206: Dose 2
- Where
- 9 sites in United States
- Volunteers
- 90 people
- Sponsor
- Jazz Pharmaceuticals
HER2-positive Breast Cancer, Breast Cancer
A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer
The purpose of this study is to see if zanidatamab is safe and effective, when combined with chemotherapy, in treating people who has Human Epidermal Growth Factor Receptor 2 (HER2)-positive, early-stage breast cancer
- Trial name
- EmpowHER 208 (NCT07102381)
- Testing
- Zanidatamab, Paclitaxel, Docetaxel
- Where
- 44 sites in United States, Germany and 2 more
- Volunteers
- 125 people
- Sponsor
- Jazz Pharmaceuticals
HER2-positive Breast Cancer, Metastatic Cancer
PRE-ISPY Phase I/II Oncology Platform Program
PRE-ISPY Phase I/II (I-SPY-P1) is an open-label, multisite platform study with multiple ongoing drug regimen arms added by protocol amendment which is designed to evaluate single agents or combinations in locally advanced…
- Conditions
- HER2-positive Breast Cancer, Metastatic Cancer, Metastatic Breast Cancer, Metastatic
- Trial name
- PRE-ISPY (NCT05868226)
- Testing
- ALX148, Fam-Trastuzumab Deruxtecan-Nxki, Zanidatamab
- Where
- 10 sites in United States
- Volunteers
- 280 people
- Sponsor
- QuantumLeap Healthcare Collaborative
B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative, T Acute Lymphoblastic Leukemia
Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) With or Without Rituximab Plus Recombinant Erwinia Asparaginase (JZP458) for the Treatment of Newly Diagnosed Ph Negative B-Acute Lymphoblastic Leukemia or T Acute Lymphoblastic Leukemia
This phase II trial tests how well etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin (DA-EPOCH) with or without rituximab plus recombinant Erwinia asparaginase (JZP458) works in treating patients with newly…
- Trial name
- NCT06738368
- Testing
- Asparaginase Erwinia chrysanthemi, Biospecimen Collection, Bone Marrow Collection
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Washington