Trial Outcomes & Findings for Solriamfetol in Improving Sleep in Patients With Grade II-IV Glioma (NCT NCT03868943)

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

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

Results posted on

2025-10-21

Participant Flow

The study was terminated early. Only 2 participants were enrolled in this study, with only one completing fully. Based on the low enrollment number, some outcomes have no data reported while other outcomes are reported in broad ranges in order to protect and maintain participant privacy/confidentiality.

Participant milestones

Participant milestones
Measure	Solriamfetol Given orally daily 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).
Overall Study STARTED	2
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Solriamfetol Given orally daily 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).
Overall Study Adverse Event	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Solriamfetol n=2 Participants Given orally daily 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).
Age, Customized 45-70 years	2 Participants n=5 Participants
Sex/Gender, Customized White male	1 Participants n=5 Participants
Sex/Gender, Customized White female	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

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

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

Outcome measures

Outcome measures
Measure	Solriamfetol n=2 Participants Given orally daily 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).
Proportion With Grade 3 or Higher Adverse Events	0 Participants

SECONDARY outcome

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

Population: The study was terminated early with only 2 participant were enrolled in this study. Based on the low enrollment number, data is reported in broad ranges in order to protect and maintain participant privacy/confidentiality.

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)

Outcome measures

Outcome measures
Measure	Solriamfetol n=2 Participants Given orally daily 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).
Epworth Sleepiness Scale ESS total score 0-2	0 Participants
Epworth Sleepiness Scale ESS total score 2-18	2 Participants
Epworth Sleepiness Scale ESS total score 19-24	0 Participants

SECONDARY outcome

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

Population: The study was terminated early with only 2 participant were enrolled in this study. Based on the low enrollment number, data is reported in broad ranges in order to protect and maintain participant privacy/confidentiality.

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.

Outcome measures

Outcome measures
Measure	Solriamfetol n=2 Participants Given orally daily 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).
Pittsburgh Sleep Quality Index (PSQI) PSQI total score 0-5 (good sleep quality)	0 Participants
Pittsburgh Sleep Quality Index (PSQI) PSQI total score 6-21 (bad sleep quality)	2 Participants

SECONDARY outcome

Timeframe: post treatment

Population: The study was terminated early with only 2 participant were enrolled in this study with only one patient completing the neurocognitive battery at the conclusion of the treatment. Since data for only one patient is available, no results are reported to protect the privacy of the patient.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: The study was terminated early with only 2 participant were enrolled in this study. Based on the low enrollment number, data is reported in broad ranges in order to protect and maintain participant privacy/confidentiality.

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.

Outcome measures

Outcome measures
Measure	Solriamfetol n=2 Participants Given orally daily 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).
Cancer Fatigue Scale (CFS) CFS total score 15-35	2 Participants
Cancer Fatigue Scale (CFS) CFS total score 36-55	0 Participants
Cancer Fatigue Scale (CFS) CFS total score 56-75	0 Participants

SECONDARY outcome

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

Population: The study was terminated early with only 2 participant were enrolled in this study. Based on the low enrollment number, data is reported in broad ranges in order to protect and maintain participant privacy/confidentiality.

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).

Outcome measures

Outcome measures
Measure	Solriamfetol n=2 Participants Given orally daily 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).
Beck's Depression Inventory (BDI) BDI score 0-40 (none - severe depression)	2 Participants
Beck's Depression Inventory (BDI) BDI score 41-63 (Extreme depression)	0 Participants

SECONDARY outcome

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

Population: The study was terminated early with only 2 participant were enrolled in this study. Based on the low enrollment number, data is reported in broad ranges in order to protect and maintain participant privacy/confidentiality.

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

Outcome measures

Outcome measures
Measure	Solriamfetol n=2 Participants Given orally daily 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).
FACT-Brain Module (FACT-Br) 0-80	0 Participants
FACT-Brain Module (FACT-Br) 81-160	2 Participants
FACT-Brain Module (FACT-Br) 161-200	0 Participants

SECONDARY outcome

Timeframe: Approximately over 10 weeks post treatment

Population: The study was terminated early and this data was not collected at the end of study treatment due to patient refusal.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately 10 weeks post treatment

Population: The study was terminated early and this data was not collected at the end of study treatment due to patient refusal.

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.

Outcome measures

Outcome data not reported

Adverse Events

Solriamfetol

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Solriamfetol n=2 participants at risk Given orally daily 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).
Gastrointestinal disorders Other	100.0% 2/2 • Number of events 6 • Up to 4 months.
Infections and infestations Other	50.0% 1/2 • Number of events 1 • Up to 4 months.
Nervous system disorders Other	50.0% 1/2 • Number of events 1 • Up to 4 months.
Psychiatric disorders Other	50.0% 1/2 • Number of events 1 • Up to 4 months.

Additional Information

Principal Investigator

Wake Forest Baptist Comprehensive Cancer Center

Phone: 336-716-7548

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place