NCT03868943

Solriamfetol in Improving Sleep in Patients With Grade II-IV Glioma

Open Label Safety Study of Solriamfetol to Promote Wakefulness and Improve Cognition and Quality of Life in Patients With Primary Gliomas

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Primary Objective: I. To estimate the safety of solriamfetol at 75 mg daily, 150 mg daily, 300 mg daily as assessed by NCI CTC Adverse Events (v5.0) in patients with primary gliomas compared to prior studies. Secondary Objective(s): I. To estimate the effect of solriamfetol on sleep by Epworth Sleepiness Scores (ESS) scores in patients with primary gliomas and compare the effect to previously published scores in patients with OSA II. To estimate the effect of solriamfetol on sleep quality by Pittsburgh Sleep Quality Index scores III. To estimate the effect of solriamfetol on neurocognitive function based on a disease-specific neurocognitive battery (see neurocognitive battery below) IV. To estimate the effect of solriamfetol on patient-reported fatigue (Brief Fatigue Inventory, Cancer Fatigue Scale) \& mood (Beck's Depression Inventory) V. To estimate the effect of solriamfetol on patient-reported QOL (FACT-Br) VI. To estimate the effect of solriamfetol on objective sleep-wake times by actigraphy and sleep diary (pre- vs post-treatment) Exploratory Objective(s) I. To explore a biologic gradient effect of increasing doses of solriamfetol on actigraphy II. To explore differences in clinical activity of solriamfetol by corticosteroid use, antiepileptic use, and tumor grade. OUTLINE: This is a dose-escalation study. Patients receive solriamfetol orally (PO) once daily (QD) for up to 6 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days.

Conditions

• Glioma
• Glioblastoma

Interventions

Type	Name	Description
DRUG	Soliramfetol	Solriamfetol will be dosed by flexible dose titration starting at 75 mg daily in all patients and escalating after 7 days (1 week) to 150 mg daily and then after 7 days to 300 mg daily for a total duration of 3 weeks (flexible dose titration period).

Timeline

• Start date: 2021-01-27
• Primary completion: 2021-11-22
• Completion: 2021-11-22
• First posted: 2019-03-11
• Last updated: 2025-10-21
• Results posted: 2025-10-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study