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GliomaPhase 2JAZZNCT03868943

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

A Phase 2 study testing Soliramfetol in people with Glioma and Glioblastoma, run by Wake Forest University Health Sciences at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioma, Glioblastoma
What is being tested?
Soliramfetol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited States
Study dates
27 Jan 2021to 22 Nov 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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 have stable disease by imaging are eligible and can continue the current anti-cancer therapy. Patients who will require a new anti-cancer treatment or are anticipated to change anti-cancer treatments are not eligible.
  • Age > 18 years
  • Karnofsky performance status ≥ 60%
  • Life expectancy of greater than 4 months
  • Patients must have normal organ and marrow function as defined below:
  • leukocytes >3,000/mcL absolute neutrophil count >1,500/mcL platelets >100,000/mcL total bilirubin 1.5 X institutional upper limits of normal AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal creatinine within normal institutional limits OR creatinine clearance >50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
  • The effects of solriamfetol on the developing human fetus are unknown. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative)

Who cannot join

  • Receiving active radiation therapy (including patients who are within 28 days of completing radiation therapy)
  • Anticipated to undergo radiation therapy or require neurosurgical intervention during the period of active treatment(i.e. within the next 4 months)
  • Contraindication to solriamfetol based on drug-drug interactions or concurrent systemic illness that precludes drug treatment
  • Patients who have not recovered to < CTCAE grade 2 toxicities related to prior or current therapy are ineligible.
  • Exception for laboratory-based or other adverse event that is stable and not anticipated to interfere with study related treatment must be reviewed and approved by the study chair
  • Customary bedtime later than midnight
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  • Known and/or documented history of obstructive sleep apnea (OSA)
  • Uncontrolled behavioral or psychiatric disorder (including suicidal ideation)
  • Current excessive caffeine use (> 600 mg/day or > 6 cups of coffee/day)
  • Current or prior history of alcohol or drug abuse within the last 2 years as assessed by the treating clinician
  • Nicotine dependence that is currently interfering with sleep based on assessment by the treating clinician
  • Concurrent use of selective serotonin or norepinephrine reuptake inhibitors (e.g. selective serotonin reuptake inhibitor [SSRI], serotonin and norepinephrine reuptake inhibitors [SNRI]) within 14 days of study enrollment
  • Patients who are currently taking these agents may be tapered at the direction of the treating physician prior to study enrollment
  • Patients taking other medications such as narcotics, benzodiazepines, antipsychotics, antiepileptics, corticosteroids, or over-the-counter sleep aids can be enrolled. It is recommended that the doses of these medications remain the same throughout the portion of active study treatment unless there is a medical indication for dose adjustment which will be determined by the treating physician
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to solriamfetol
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant women are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with solriamfetol, breastfeeding should be discontinued if the mother is treated with solriamfetol

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Wake Forest Baptist Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

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

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).

Read the detailed description

Primary Objective:

  1. 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):

  1. 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)

  1. 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)

  1. 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
Being tested
Soliramfetol
Medical subject headings
Glioma, Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SoliramfetolDrug

    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).

Study groups in NCT03868943
Study groupRoleWhat they receive
SolriamfetolExperimentalGiven orally daily
Receives: Drug: Soliramfetol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion With Grade 3 or Higher Adverse Events

    National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be used for scoring toxicity and adverse events. Score of 1 to 5 (1 = mild, 5 = death). The proportions of subjects who experienced grade 3 or above toxicities will be estimated

    Measured: Duration of treatment (timing ranges from 3 weeks to 9 weeks past start of treatment)

Secondary outcomes (8)

  1. Epworth Sleepiness Scale

    The effect of solriamfetol on patient-reported sleep using Epworth Sleepiness Scale measuring how likely participants are likely to doze off or fall asleep in certain situations (8 situations), in contrast to feeling tired. Scale of 0 would never doze, 1 - slight chance of dozing, 2 - moderate chance of dozing and 3 - high chance of dozing. Score is the sum of the eight items (range 0-24)

    Measured: End of treatment (timing ranges from 3 weeks to 9 weeks past start of treatment)

  2. Pittsburgh Sleep Quality Index (PSQI)

    The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month. Each item is on a scale 0 - 3. The total score is a sum of the seven items, ranging from 0-21 with lower scores indicating better sleep.

    Measured: End of treatment (timing ranges from 3 weeks to 9 weeks past start of treatment)

  3. Neurocognitive Battery Record

    Evaluation of attention, concentration, information processing speed, learning/memory and aspects of higher-order executive functions to be done at baseline and end of treatment only.

    Measured: post treatment

  4. Cancer Fatigue Scale (CFS)

    15-item self-administered patient-reported questionnaire exploring both overall and domain specific fatigue in cancer patients. The instrument explores three fatigue domains: physical effects of fatigue, cognitive effects, and affective issues related to cancer fatigue. Each response is measured 1 - No, 2 - a little, 3 - somewhat, 4 considerably and 5 - very much, with a sum of the 15 items as the total score (range 15-75). Higher scores generally indicate greater fatigue/severity.

    Measured: End of treatment (timing ranges from 3 weeks to 9 weeks past start of treatment)

  5. Beck's Depression Inventory (BDI)

    A 21 item self-scored questionnaire to assess levels of depression. Each item is rated on a scale from 0-3, with the total score being the sum of the 21 items (range 0-63).

    Measured: End of treatment (timing ranges from 3 weeks to 9 weeks past start of treatment)

  6. FACT-Brain Module (FACT-Br)

    An instrument measuring general quality of life (QOL) that reflects symptoms or problems associated with brain malignancies across 5 scales (physical well being, social/family well being, emotional well being, functional well being and additional concerns). Each of the 50 items are on a scale: 0 - not all all, 1 - a little bit, 2 - somewhat - 3 - quite a bit and 4 - very much. Total score has a range 0-200. Higher scores across all subscales and total scores indicate a better quality of life

    Measured: End of treatment (timing ranges from 3 weeks to 9 weeks past start of treatment)

  7. 7 Day Actigraphy

    Actigraph devices are worn on the wrist for 7 days and record movements that can be used to estimate sleep patterns using specialized computer software programs. Completion of actigraphy will be done from baseline to end of treatment and recorded with the sleep-diary data.

    Measured: Approximately over 10 weeks post treatment

  8. 7-day Patient-Reported Sleep Diary

    Participants will be provided a sleep diary at the time of consent and/or study enrollment. All sleep diaries will be collected over 7-days including at pre-study baseline, throughout each dose of the dose escalation phase, and during the first 7-days and last 7-days of the fixed dose drug continuation phase of the study. Caregivers may complete sleep diaries for patients.

    Measured: Approximately 10 weeks post treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2019
  2. Study start27 Jan 2021
  3. Primary completion22 Nov 2021
  4. Study completion22 Nov 2021

Why it stopped: Axsome has conducted a review of the ongoing IST program and are unable to continue supporting this study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03868943
Sponsor's protocol ID
IRB00056700
Other IDs
NCI-2019-01299, P30CA012197, CCCWFU 98418
Acronym
JAZZ
Status last verified
Jul 2026
First submitted
7 Mar 2019
Last updated
3 Aug 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Soliramfetol in people with Glioma and Glioblastoma, run by Wake Forest University Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion With Grade 3 or Higher Adverse Events (time frame: Duration of treatment (timing ranges from 3 weeks to 9 weeks past start of treatment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03868943.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.

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