9 completed, 2 not yet recruiting, 2 withdrawn, 1 active not recruiting. 16 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 4 | 16 | Completed 9, Not yet recruiting 2, Withdrawn 2, Active not recruiting 1, Terminated 1, Unknown 1 |
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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 |
|---|---|---|---|---|---|---|
| A Study to Investigate the Transition of Children From 'Artisanal" Cannabidiol (CBD) to Epidiolex Epidiolex 100 mg/mL Oral Solution - Dravet Syndrome (DS), Lennox-Gastaut Syndrome (LGS) | Phase 4 | Not yet recruiting | Elizabeth Donner | 25 | 2027-01-01 | 2026-09-11 |
| A Study to Investigate the Effect of Gradual Titration to Optimize Cannabidiol Treatment in Adults With LGS Cannabidiol Oral Solution - Lennox-Gastaut Syndrome | Phase 4 | Not yet recruiting | Jazz Pharmaceuticals | 40 | 2026-11-18 | 2026-10-22 |
| A Study to Investigate the Effect of XYWAV on Sleepiness, Polysomnography, and Functional Outcomes in Participants With Idiopathic Hypersomnia or Narcolepsy JZP258 (XYWAV) - Idiopathic Hypersomnia, Narcolepsy | Phase 4 | Completed | Jazz Pharmaceuticals | 199 | 2023-07-27 | 2026-08-27 |
| A Study to Investigate Behavioral and Other Co-Occurring Outcomes With Epidiolex as Add-On Therapy in Participants Aged 1 to 65 Years of Age With Tuberous Sclerosis Complex Cannabidiol Oral Solution [Epidiolex] - Tuberous Sclerosis Complex Associated Neuropsychiatric Disease | Phase 4 | Completed | Jazz Pharmaceuticals | 79 | 2023-06-29 | 2026-04-27 |
| A Switch Study From High-Sodium Oxybate to Xywav to Evaluate Changes in Blood Pressure in Participants With Narcolepsy JZP258 - Narcolepsy | Phase 4 | Completed | Jazz Pharmaceuticals | 155 | 2023-06-26 | 2026-04-24 |
| Epidiolex in Typical Absence Seizures Cannabidiol (Epidiolex) - Study the Efficacy of Epidiolex for Typical Absence Seizures | Phase 4 | Completed | University of South Florida | 14 | 2021-07-30 | 2023-07-11 |
| Assessment of Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral Solution Cannabidiol - Lennox Gastaut Syndrome, Dravet Syndrome | Phase 4 | Active not recruiting | Jazz Pharmaceuticals | 154 | 2021-07-07 | 2026-08-26 |
| Solriamfetol in Binge Eating Disorder Solriamfetol, Placebo - Binge Eating Disorder | Phase 4 | Unknown | Lindner Center of HOPE | 64 | 2021-06-15 | 2023-03-08 |
| An Interventional Safety Switch Study (Segue Study) of XYWAV in Narcolepsy JZP-258 - Narcolepsy | Phase 4 | Completed | Jazz Pharmaceuticals | 62 | 2021-03-22 | 2024-01-09 |
| Investigation of Cognitive Outcomes With Cannabidiol Oral Solution GWP42003-P - Lennox-Gastaut Syndrome | Phase 4 | Withdrawn | Jazz Pharmaceuticals | 2020-10-01 | 2022-09-01 | |
| Treatment of REM Sleep Behavior Disorder (RBD) With Sodium Oxybate Sodium Oxybate, Placebo - REM Sleep Behavior Disorder, Parkinson Disease | Phase 4 | Completed | Stanford University | 24 | 2019-09-10 | 2023-05-10 |
| A Randomized Study of Sativex on Cognitive Function and Mood: Multiple Sclerosis Patients Sativex, Placebo - Multiple Sclerosis, Spasticity | Phase 4 | Completed | Jazz Pharmaceuticals | 121 | 2012-01-01 | 2023-01-12 |
| A Study to Compare the Efficacy of Rapydan Versus Tetracaine Gel Rapydan, tetracaine gel - Healthy, Anesthesia | Phase 4 | Withdrawn | Jazz Pharmaceuticals | 2008-04-01 | 2012-04-25 | |
| Enhancing Slow Wave Sleep With Sodium Oxybate sodium oxybate - Sleep | Phase 4 | Completed | St. Luke's Hospital, Chesterfield, Missouri | 60 | 2007-05-01 | 2008-09-26 |
| Use of Xyrem to Improve Sleep in Chronic Fatigue Syndrome Placebo, Sodium Oxybate - Chronic Fatigue Syndrome | Phase 4 | Terminated | University of Medicine and Dentistry of New Jersey | 17 | 2007-05-01 | 2016-05-19 |
| Trial of Effects of Oral Xyrem and Zolpidem on Sleep-Disordered Breathing in Obstructive Sleep Apnea Patients Xyrem (X), Zolpidem (Z), Modafinil (M) - Obstructive Sleep Apnea Syndrome | Phase 4 | Completed | Jazz Pharmaceuticals | 60 | 2003-11-01 | 2012-02-24 |
Lennox Gastaut Syndrome (4) · Narcolepsy (3) · Epilepsies, Myoclonic (2) · Seizures (2) · Tuberous Sclerosis (2) · Behavior (1) · Binge-Eating Disorder (1) · Bronchiolitis Obliterans Syndrome (1) · Disorders of Excessive Somnolence (1) · Epilepsy (1) · Fatigue (1) · Fatigue Syndrome, Chronic (1) · Idiopathic Hypersomnia (1) · Liver Cirrhosis (1) · Multiple Sclerosis (1)
Cannabidiol (6) · Sodium Oxybate (4) · Modafinil (1) · Solutions (1) · Zolpidem (1) · nabiximols (1) · solriamfetol (1)
United States (12) · Canada (4) · United Kingdom (2) · Belgium (1) · Czechia (1) · France (1) · Italy (1) · Poland (1) · Spain (1)
Benjamin Natelson, MD (1) · Elizabeth Donner, MD (1) · Emmanuel During, MD (1) · James K Walsh, Ph.D. (1) · Rahul Dimber, MD (1) · Yanping Zheng, MD (1)
PMID 24151639, PMID 34532852, PMID 34610482, PMID 37052688, PMID 38652499, PMID 41090230, PMID 41831073, PMID 42060037, PMID 42435131
2023 (1)