Solriamfetol in Improving Sleep in Patients With Grade II-IV Glioma (NCT03868943) | Clinical Trial Compass
TerminatedPhase 2
Solriamfetol in Improving Sleep in Patients With Grade II-IV Glioma
Stopped: Axsome has conducted a review of the ongoing IST program and are unable to continue supporting this study
United States2 participantsStarted 2021-01-27
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
WHO Grade 2-4 infiltrating glioma by histologic confirmation
* Where appropriate results from clinically available testing of isocitrate dehydrogenase (IDH) gene mutation status (for all gliomas), chromosome 1p and 19q deletion status (for suspected oligodendrogliomas), and MGMT gene promoter methylation status (for malignant gliomas) must be available in the patient's chart.
* These studies are standard of care molecular studies that are performed as a part of routine clinical practice and allow for integrated molecular subtyping of primary glial tumors.
Epworth Sleepiness Scale (ESS) score \>10 within 21 days of enrollment
Clinical and/or radiographic evidence of stable disease within 21 days of enrollment
* Patients must have completed concurrent chemoradiation with recovery of all pre-existing toxicity to CTCAE Grade \>1
* Patient who are anticipated to undergo surgery and/or radiation therapy for management of their tumor during the duration of study treatment are NOT eligible.
* Patients who are anticipated to undergo adjuvant chemotherapy are eligible as long as there is no evidence of tumor progression by clinical exam and/or imaging within 21 days of enrollment (see 4.1.2). This determination should be made by clinical documentation and if there is question discussed with the Study Chair. Adjuvant chemotherapy is not an exclusion.
* Patients who are currently undergoing chemotherapy, targeted therapy, immunotherapy, or salvage treatment and h…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before completion — can you find out why it was stopped, and whether that tells us anything important about the safety or usefulness of solriamfetol for glioma patients like me?
2The main thing this Phase 2 trial was measuring was the proportion of patients who experienced serious side effects (Grade 3 or higher) — given that it was terminated, what do we actually know so far about how safe solriamfetol is for someone with a Grade II-IV glioma?
3Since this study was specifically looking at sleep problems in glioma patients, are there other ways to address sleep or fatigue that have more complete evidence behind them that we could consider instead?
4Because this was only Phase 2 and the trial was terminated, does that mean there are still too many unknowns about this drug for glioma to make it a realistic option for me right now?
5Are there any other active clinical trials or standard treatments targeting sleep issues or fatigue in glioblastoma or high-grade glioma that you think would be worth exploring given that this one didn't complete?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion With Grade 3 or Higher Adverse Events
Timeframe: Duration of treatment (timing ranges from 3 weeks to 9 weeks past start of treatment)