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
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
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
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
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
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+/HR+ Breast Cancer
Phase 2a Study of ZW25 in Combination With Palbociclib Plus Fulvestrant
This is a multicenter, Phase 2a, open-label, 2-part study to investigate the safety, tolerability, and anti-tumor activity of ZW25 (zanidatamab) in combination with palbociclib plus fulvestrant.
- Trial name
- NCT04224272
- Testing
- ZW25 (Zanidatamab), Palbociclib, Fulvestrant
- Where
- 13 sites in United States, Canada and 1 more
- Volunteers
- 51 people
- Sponsor
- Jazz Pharmaceuticals
Extensive-stage Small-cell Lung Cancer
A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC
The purpose of this study is to evaluate the efficacy and safety of lurbinectedin in combination with durvalumab for the treatment of participants with extensive stage small cell lung cancer (ES-SCLC) whose disease has not…
- Trial name
- NCT07459634
- Testing
- Lurbinectedin, Durvalumab
- Where
- 5 sites in United States
- Volunteers
- 50 people
- Sponsor
- Jazz Pharmaceuticals
Biliary Tract Cancer
Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer
The purpose of this study is to evaluate the efficacy and safety of Zanidatamab plus CisGem (Cisplatin and Gemcitabine) with or without the addition of a programmed death protein 1/ligand-1 (PD-1/L1) inhibitor (physician's choice…
- Trial name
- NCT06282575
- Testing
- Zanidatamab, Cisplatin, Gemcitabine
- Where
- 185 sites in United States, Argentina and 23 more
- Volunteers
- 286 people
- Sponsor
- Jazz Pharmaceuticals
Advanced Cancer, Metastatic Cancer
A Study of JZP815 Oral Capsules in Adult Participants With Advanced or Metastatic Solid Tumors Harboring Mitogen Activated Protein Kinase (MAPK) Pathway Alterations to Investigate the Safety, Dosing, and Antitumor Activity of JZP815
This phase 1 study will investigate the safety, dosing, and initial antitumor activity of JZP815 in participants with advanced or metastatic solid tumors harboring alterations in the MAPK pathway.
- Conditions
- Advanced Cancer, Metastatic Cancer, Solid Tumor, Melanoma
- Trial name
- NCT05557045
- Testing
- JZP815
- Where
- 15 sites in United States
- Volunteers
- 98 people
- Sponsor
- Jazz Pharmaceuticals
Healthy Participants
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JZP269 in Healthy Male and Female Participants
This study will characterize the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) of JZP269 in healthy participants.
- Trial name
- NCT07813663
- Testing
- JZP269
- Volunteers
- 188 people, healthy volunteers welcome
- Sponsor
- Jazz Pharmaceuticals
Idiopathic Hypersomnia, Narcolepsy
A Study to Investigate the Effect of XYWAV on Sleepiness, Polysomnography, and Functional Outcomes in Participants With Idiopathic Hypersomnia or Narcolepsy
This study will assess the safety and efficacy of JZP258 (XYWAV) on sleepiness, polysomnography, and functional outcomes in patients with idiopathic hypersomnia (IH) or narcolepsy.
- Trial name
- NCT05875974
- Testing
- JZP258 (XYWAV)
- Where
- 32 sites in United States, Canada
- Volunteers
- 199 people
- Sponsor
- Jazz Pharmaceuticals
Lennox Gastaut Syndrome, Dravet Syndrome
Assessment of Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral Solution
This study will monitor for potential chronic liver injury and liver fibrosis, in participants treated with cannabidiol oral solution.
- Conditions
- Lennox Gastaut Syndrome, Dravet Syndrome, Tuberous Sclerosis Complex
- Trial name
- NCT05044819
- Testing
- Cannabidiol
- Where
- 26 sites in United States
- Volunteers
- 154 people
- Sponsor
- Jazz Pharmaceuticals
Meningioma
A Study of JZP3507 (ONC206) in Recurrent Grade 2 or 3 Meningioma
This study will recruit participants with Grade 2 and 3 meningiomas who have failed prior therapy. Participants will receive oral doses of JZP3507. The antitumor activity and safety of JZP3507 will be evaluated.
- Trial name
- NCT07533942
- Testing
- JZP3507
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Jazz Pharmaceuticals
Developmental and Epileptic Encephalopathy (DEE)
A Study to Evaluate the Safety and Efficacy of CBD-OS in Participants With DEE
The efficacy, safety, and tolerability of CBD-OS have been evaluated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), and Tuberous sclerosis complex (TSC).
- Trial name
- NCT07723976
- Testing
- CBD-OS
- Volunteers
- 120 people
- Sponsor
- Jazz Pharmaceuticals