Clinical trials: sponsored by 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
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
Narcolepsy
A Switch Study From High-Sodium Oxybate to Xywav to Evaluate Changes in Blood Pressure in Participants With Narcolepsy
The aim of this study is to quantify the change in blood pressure when participants with narcolepsy treated with high-sodium oxybate are transitioned to Xywav, a low-sodium oxybate.
- Trial name
- XYLO (NCT05869773)
- Testing
- JZP258
- Where
- 43 sites in United States, Belgium and 3 more
- Volunteers
- 155 people
- Sponsor
- Jazz Pharmaceuticals
Parkinson Disease, Tremor
A Study of Suvecaltamide in Adults With Moderate to Severe Residual Tremor in Parkinson's Disease
This is a 17-week double-blind, placebo-controlled, randomized, flexible-dosing, parallel-group, multicenter study designed to evaluate the efficacy and safety of suvecaltamide for the treatment of moderate to severe residual…
- Trial name
- NCT05642442
- Testing
- Suvecaltamide
- Where
- 37 sites in United States, Germany and 2 more
- Volunteers
- 169 people
- Sponsor
- Jazz Pharmaceuticals
Seizure in Participants With Tuberous Sclerosis Complex, Seizure in Participants With Dravet Syndrome
Assessment of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Children With Tuberous Sclerosis Complex (TSC), Dravet Syndrome (DS), or Lennox-Gastaut Syndrome (LGS) Who Experience Inadequately-controlled Seizures
This study will be conducted to evaluate the safety, pharmacokinetics (PK), and efficacy of adjunctive GWP42003-P in participants < 2 years of age with tuberous sclerosis complex (TSC), Lennox-Gastaut syndrome (LGS), or Dravet…
- Conditions
- Seizure in Participants With Tuberous Sclerosis Complex, Seizure in Participants With Dravet Syndrome, Seizure in Participants With Lennox-Gastaut Syndrome
- Trial name
- NCT04485104
- Testing
- GWP42003-P
- Where
- 11 sites in United States, Italy and 1 more
- Volunteers
- 3 people
- Sponsor
- Jazz Pharmaceuticals
HER2-amplified Biliary Tract Cancers
A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers
This multicenter, open-label, single-arm trial will evaluate the anti-tumor activity of ZW25 (zanidatamab) monotherapy in subjects with human epidermal growth factor receptor 2 (HER2)-amplified, inoperable and advanced or…
- Trial name
- HERIZON-BTC-01 (NCT04466891)
- Testing
- ZW25 (Zanidatamab)
- Where
- 67 sites in United States, Canada and 7 more
- Volunteers
- 87 people
- Sponsor
- Jazz Pharmaceuticals
Glioma
ONC201 in Adults With Recurrent H3 K27M-mutant Glioma
This was a Phase 2, open-label, 2-arm study of dordaviprone (ONC201) in patients with recurrent H3 K27M- mutant glioma. The primary assessment of dordaviprone (ONC201) involved evaluating its anti-tumor activity through the…
- Trial name
- NCT03295396
- Testing
- Dordaviprone (ONC201)
- Where
- 9 sites in United States
- Volunteers
- 73 people
- Sponsor
- Jazz Pharmaceuticals
Essential Tremor
A Study To Assess the Safety and Efficacy of JZP385 in the Treatment of Adults With Moderate to Severe Essential Tremor (ET)
This is a 12-week, double-blind, placebo-controlled, randomized, parallel-group, multicenter study of the safety and efficacy of JZP385 in the treatment of adult participants with moderate to severe ET.
- Trial name
- NCT05122650
- Testing
- JZP385
- Where
- 73 sites in United States, Germany and 2 more
- Volunteers
- 420 people
- 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
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
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
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