Clinical trials: sponsored by Jazz Pharmaceuticals
HER2-Positive Advanced Biliary Tract Cancer
An Expanded Access Treatment Protocol of Zanidatamab (ZW25) in Patients With HER2-Positive Advanced Biliary Tract Cancer
This is an intermediate-size Expanded Access Protocol (EAP) for use of zanidatamab (ZW25) in patients with human epidermal growth factor receptor 2 (HER2)-positive advanced biliary tract cancer (BTC) who are not eligible for…
- Trial name
- NCT04578444
- Testing
- Zanidatamab
- Where
- 17 sites in United States, France and 3 more
- Sponsor
- Jazz Pharmaceuticals
Autism Spectrum Disorder
Trial to Investigate the Safety and Efficacy of Cannabidiol Oral Solution (GWP42003-P; CBD-OS) in Children and Adolescents With Autism Spectrum Disorder
This study will be conducted to evaluate the efficacy of GWP42003-P, compared with placebo, in reducing symptom severity in children with Autism Spectrum Disorder (ASD).
- Trial name
- NCT04745026
- Testing
- GWP42003-P
- Where
- 23 sites in United States, Australia and 4 more
- Volunteers
- 103 people
- Sponsor
- Jazz Pharmaceuticals
Advanced Solid Tumor, Metastatic Solid Tumor
Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid Tumors
This is an open-label, multicenter, phase 2 study of lurbinectedin monotherapy in participants with advanced (metastatic and/or unresectable) solid tumors.
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumor, Urothelial Cancer, Poorly Differentiated Neuroendocrine Carcinomas
- Trial name
- JAZZ EMERGE201 (NCT05126433)
- Testing
- Lurbinectedin
- Where
- 17 sites in United States
- Volunteers
- 47 people
- Sponsor
- Jazz Pharmaceuticals
Diffuse Intrinsic Pontine Glioma, Glioma, Malignant
ONC201 in Pediatric H3 K27M Gliomas
This was a Phase 1, open label, multicenter, 8-arm, dose escalation study of dordaviprone (ONC201) in pediatric patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) and recurrent/refractory H3 K27M-mutant…
- Trial name
- NCT03416530
- Testing
- Dordaviprone (ONC201)
- Where
- 8 sites in United States
- Volunteers
- 134 people
- Sponsor
- Jazz Pharmaceuticals
Seizures Associated With EMAS
Efficacy and Safety of GWP42003-P Oral Solution in Children With Epilepsy With Myoclonic-atonic Seizures
The primary aim of Part A of the study to assess the efficacy and tolerability of GWP42003-P compared to placebo as an adjunctive treatment for children with Epilepsy with myoclonic-atonic seizures (EMAS) -associated seizures.
- Trial name
- NCT05288283
- Testing
- GWP42003-P
- Where
- 14 sites in United States, Italy
- Volunteers
- 3 people
- Sponsor
- Jazz Pharmaceuticals
Post Traumatic Stress Disorder
A Study of JZP150 in Adults With Posttraumatic Stress Disorder
This is a 12-week, double-blind, placebo-controlled, randomized, parallel-group, multicenter study of the safety and efficacy of JZP150 in the treatment of adult participants with post-traumatic stress disorder (PTSD).
- Trial name
- NCT05178316
- Testing
- JZP150
- Where
- 52 sites in United States
- Volunteers
- 282 people
- Sponsor
- Jazz Pharmaceuticals
Glioblastoma, Diffuse Midline Glioma
Oral ONC201 in Adult Recurrent Glioblastoma
This was a Phase 2, open-label, 6-arm, multi-center study of dordaviprone (ONC201) in patients with recurrent glioblastoma (Arms A, B, and C), H3 K27M-mutant diffuse glioma (Arm D), or diffuse midline glioma (Arms E and F).
- Conditions
- Glioblastoma, Diffuse Midline Glioma, H3 K27M Glioma, Thalamic Glioma
- Trial name
- NCT02525692
- Testing
- Dordaviprone (ONC201)
- Where
- 5 sites in United States
- Volunteers
- 84 people
- Sponsor
- Jazz Pharmaceuticals
Endometrial Cancer Recurrent
ONC201 in Recurrent or Metastatic Type II Endometrial Cancer Endometrial Cancer
This was a Phase 2, Simon two-stage, non-randomized, open-label, 2-arm trial of dordaviprone (ONC201) in women with metastatic or recurrent Type II endometrial cancer who failed at least 1 prior chemotherapy regimen.
- Trial name
- NCT03485729
- Testing
- Dordaviprone (ONC201)
- Where
- 3 sites in United States
- Volunteers
- 27 people
- Sponsor
- Jazz Pharmaceuticals
Spasticity With Multiple Sclerosis
Evaluation of the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Participants With Multiple Sclerosis
This study will be conducted to evaluate the effect of multiple doses of nabiximols compared with placebo on a clinical measure of velocity-dependent muscle tone in the lower limbs (Lower Limb Muscle Tone-6 [LLMT-6]) in…
- Trial name
- RELEASE MSS5 (NCT04984278)
- Testing
- Nabiximols
- Where
- 30 sites in United States, Czechia and 3 more
- Volunteers
- 56 people
- Sponsor
- Jazz Pharmaceuticals
HER2-expressing Cancers
Trial of ZW25 (Zanidatamab) in Patients With Advanced HER2-expressing Cancers
This is a first-in-human, 3-part study to investigate the safety, tolerability, and effectiveness of ZW25 (zanidatamab) by itself and combined with selected chemotherapy agents in patients with locally advanced (unresectable)…
- Trial name
- NCT02892123
- Testing
- ZW25 (Zanidatamab), Paclitaxel, Capecitabine
- Where
- 17 sites in United States, Canada and 1 more
- Volunteers
- 279 people
- Sponsor
- Jazz Pharmaceuticals
Irritability Associated With Autism Spectrum Disorder, Autism Spectrum Disorder
A Study of JZP541 in Adults With Irritability Associated With Autism Spectrum Disorder
Behavior dysregulation is commonly associated with people with autism spectrum disorder (ASD). Irritability is a major safety concern in adults with ASD.
- Conditions
- Irritability Associated With Autism Spectrum Disorder, Autism Spectrum Disorder, ASD
- Trial name
- NCT05733390
- Testing
- JZP541
- Where
- United States
- Sponsor
- Jazz Pharmaceuticals
Healthy Participants
A Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JZP441 in Healthy Participants
Treatments for narcolepsy and hypersomnolence disorders should have good oral bioavailability and brain penetration properties. JZP441 has demonstrated wake-promoting efficacy and anticataplectic activity in nonclinical studies…
- Trial name
- NCT05720494
- Testing
- JZP441
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Jazz Pharmaceuticals
Narcolepsy
Child and Adolescent Registry for Participants With Narcolepsy
CATNAP is a patient registry designed to improve the understanding of the natural history of narcolepsy in pediatric patients. Descriptive statistics on disease characteristics will be performed.
- Trial name
- NCT04899947
- Where
- 25 sites in United States
- Volunteers
- 500 people
- Sponsor
- Jazz Pharmaceuticals
Healthy Participants
A Study to Investigate The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JZP441 in Sleep-deprived Healthy Participants
This Phase 1, double-blind, randomized, placebo-controlled study will characterize the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ascending nighttime doses of JZP441 in sleep-deprived healthy…
- Trial name
- NCT05651152
- Testing
- JZP441
- Where
- 2 sites in United States
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- Jazz Pharmaceuticals
Multiple Myeloma
Oral ONC201 in Relapsed/Refractory Multiple Myeloma
This was a Phase 1/2 open-label study of ONC201 administered orally once every week in combination with dexamethasone in adults with relapsed/refractory multiple myeloma.
- Trial name
- NCT02863991
- Testing
- ONC201, Dexamethasone
- Where
- 2 sites in United States
- Volunteers
- 17 people
- Sponsor
- Jazz Pharmaceuticals
Advanced Solid Tumor, Metastatic Solid Tumor
A JZP341 Study in Adult Participants With Advanced or Metastatic Solid Tumors
This study will assess the safety and efficacy of JZP341 in participants with advanced or metastatic solid tumors.
- Trial name
- NCT05631327
- Testing
- JZP341
- Where
- 8 sites in United States
- Volunteers
- 12 people
- Sponsor
- Jazz Pharmaceuticals
Multiple Sclerosis (MS)
Safety and Effectiveness of Nabiximols Oromucosal Spray as Add-on Therapy in Participants With Spasticity Due to Multiple Sclerosis
This trial is being conducted to demonstrate the efficacy of nabiximols, compared with placebo, when added to standard of care, in the treatment of muscle spasms associated with multiple sclerosis (MS).
- Trial name
- RELEASE MSS3 (NCT04203498)
- Testing
- Nabiximols
- Where
- 37 sites in United States, Czechia and 3 more
- Volunteers
- 139 people
- Sponsor
- Jazz Pharmaceuticals
Acute Myeloid Leukemia
Dociparstat in Combination With Standard Chemotherapy for the Treatment of Acute Myeloid Leukemia
Phase 3 study to evaluate the efficacy and safety of dociparstat sodium in adults with newly diagnosed untreated acute myeloid leukemia (AML) with adverse or intermediate genetic risk.
- Trial name
- AML (NCT04571645)
- Testing
- Dociparstat, Control
- Where
- 14 sites in United States
- Volunteers
- 9 people
- Sponsor
- Jazz Pharmaceuticals
Narcolepsy
An Interventional Safety Switch Study (Segue Study) of XYWAV in Narcolepsy
The rationale for the interventional, open-label, single-arm design of JZP258-401 is to evaluate the clinical experience in participants with narcolepsy transitioning treatment from Xyrem to XYWAV.
- Trial name
- NCT04794491
- Testing
- JZP-258
- Where
- 28 sites in United States
- Volunteers
- 62 people
- Sponsor
- Jazz Pharmaceuticals
Acute Lymphoblastic Leukemia, Lymphoblastic Leukemia
An Open-Label Study of JZP-458 (RC-P) in Patients With Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL)
This is an open-label, multicenter, dose confirmation, and PK study of JZP-458 in patients (of any age) with ALL/LBL who are hypersensitive to E. coli-derived asparaginases (allergic reaction or silent inactivation).
- Trial name
- NCT04145531
- Testing
- IM JZP-458, IV JZP-458
- Where
- 74 sites in United States, Canada
- Volunteers
- 229 people
- Sponsor
- Jazz Pharmaceuticals