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Wakefulness-Promoting Drug
Soliramfetol for Glioblastoma (JAZZ Trial)
Phase 2
Waitlist Available
Led By Roy Strowd, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 50-65 minutes at baseline and approximately 70 days post treatment
Awards & highlights
Summary
This phase II trial studies the side effects of solriamfetol in improving sleep in patients with grade II-IV glioma. Solriamfetol is a wakefulness-promoting drug. Giving solriamfetol may improve sleep, memory, fatigue, mood, or quality of life in patients with brain tumors (gliomas).
Eligible Conditions
- Glioblastoma
- Brain Tumor
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 50-65 minutes at baseline and approximately 70 days post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~50-65 minutes at baseline and approximately 70 days post treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of Adverse Events
Secondary outcome measures
7 day Actigraphy
7-day Patient-Reported Sleep Diary
Beck's Depression Inventory (BDI)
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: SolriamfetolExperimental Treatment1 Intervention
Given orally daily
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,253 Previous Clinical Trials
1,010,896 Total Patients Enrolled
10 Trials studying Glioblastoma
346 Patients Enrolled for Glioblastoma
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,365 Total Patients Enrolled
324 Trials studying Glioblastoma
23,152 Patients Enrolled for Glioblastoma
Roy Strowd, MDPrincipal InvestigatorWake Forest University Health Sciences
6 Previous Clinical Trials
98 Total Patients Enrolled
1 Trials studying Glioblastoma
24 Patients Enrolled for Glioblastoma
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