Evaluation of the Efficacy of Sodium Oxybate (Xyrem®) in Treatment of Post-traumatic Narcolepsy and Post-traumatic Hypersomnia
NCT03626727 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL
Last updated 2021-03-04
Summary
The study evaluates whether the use of Sodium Oxybate (Xyrem®) in TBI patients will be effective in reducing symptoms of post traumatic narcolepsy and post traumatic hypersomnia.
Conditions
- Hypersomnia
- Narcolepsy
- Traumatic Brain Injury
Interventions
- DRUG
-
Sodium Oxybate Oral Solution [Xyrem]
Xyrem will be given to participants to determine if it is effective in treating post-traumatic narcolepsy and post-traumatic hypersomnia
Sponsors & Collaborators
-
Brigham and Women's Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-09-30
- Primary Completion
- 2020-09-01
- Completion
- 2020-09-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Xyrem(Sodium Oxybate) and Ambien(Zolpidem Tartrate) in the Treatment of Chronic Insomnia.
NCT00383643 ·Status: COMPLETED ·Phase: PHASE2
-
A Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension
NCT03533114 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate the Efficacy and Safety of Armodafinil as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury
NCT00893789 ·Status: TERMINATED ·Phase: PHASE3
-
Study to Evaluate the Safety, Tolerability, and Efficacy of Armodafinil as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury
NCT00983437 ·Status: TERMINATED ·Phase: PHASE3
-
Treatment of REM Sleep Behavior Disorder (RBD) With Sodium Oxybate
NCT04006925 ·Status: COMPLETED ·Phase: PHASE4
-
A Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia
NCT06752668 ·Status: RECRUITING ·Phase: PHASE2
-
A Study of ORX142 in Healthy Adult Subjects, Including Subjects 18 to 80 Years of Age
NCT07082829 ·Status: RECRUITING ·Phase: PHASE1
-
A Long-term Extension Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia
NCT07096674 ·Status: RECRUITING ·Phase: PHASE2
-
"A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or OSA"
NCT02348632 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of FT218 in Idiopathic Hypersomnia (REVITALYZ)
NCT06525077 ·Status: COMPLETED ·Phase: PHASE3
-
Modafinil Versus Amphetamines for the Treatment of Narcolepsy Type 2 and Idiopathic Hypersomnia
NCT03772314 ·Status: COMPLETED ·Phase: PHASE2
-
Solriamfetol and CBT-I in Patients With Insomnia Disorder
NCT05838430 ·Status: COMPLETED ·Phase: PHASE4
-
Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study
NCT04789174 ·Status: COMPLETED ·Phase: PHASE4
-
Clinical Trial of Solriamfetol for Excessive Sleepiness Related to Shift Work Disorder
NCT04788953 ·Status: TERMINATED ·Phase: PHASE4
-
Memory Consolidation in Pharmacologically Enhanced Naps
NCT00777829 ·Status: COMPLETED ·Phase: NA
-
Effect of Rozerem on Sleep Among People With Traumatic Brain Injury
NCT01207050 ·Status: UNKNOWN ·Phase: PHASE4
-
Sodium Oxybate in Idiopathic Hypersomnia
NCT03597555 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Repurposing Dexmedetomidine as an Orally Administered Sleep Therapeutic
NCT02818569 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Suvorexant: A Dual Orexin Receptor Antagonist for Treating Sleep Disturbance in Posttraumatic Stress
NCT03642028 ·Status: RECRUITING ·Phase: PHASE4
-
An Investigational Study to Assess Efficacy and Pattern of Use of SM-1 in Subjects With a History of Transient Insomnia
NCT03338764 ·Status: WITHDRAWN ·Phase: PHASE3
-
Study to Assess Patient Reported Outcomes With Armodafinil Treatment for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome
NCT00228566 ·Status: COMPLETED ·Phase: PHASE3
-
An Efficacy Study of Compound LY2624803 in the Treatment of Patients With Chronic Insomnia
NCT00784875 ·Status: COMPLETED ·Phase: PHASE2
-
Effect of a Hypocretin/Orexin Antagonist on Neurocognitive Performance
NCT01243060 ·Status: COMPLETED ·Phase: NA
-
A Study of the Safety and Effectiveness of ADX-N05 in the Treatment of Excessive Daytime Sleepiness
NCT01485770 ·Status: COMPLETED ·Phase: PHASE2
-
Sleep Laboratory Study of MK0928 in Adult Patients With Primary Insomnia (0928-041)(TERMINATED)
NCT00266357 ·Status: TERMINATED ·Phase: PHASE2