19 completed, 6 recruiting, 2 enrolling by invitation, 1 not yet recruiting. 13 Phase 3, 10 Phase 2, 5 Phase 4, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 13 | Completed 8, Recruiting 3, Enrolling by invitation 2 |
| Phase 2 | 10 | Completed 8, Not yet recruiting 1, Recruiting 1 |
| Phase 4 | 5 | Completed 3, Terminated 1, Unknown 1 |
| Phase 1 | 1 | Completed 1 |
Follow solriamfetol: new trials by email Literature Review of solriamfetol trials Research Report on solriamfetol
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD Solriamfetol - ADHD | Phase 3 | Enrolling by invitation | Axsome Therapeutics, Inc. | 300 | 2026-08-06 | 2026-10-13 |
| Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol Solriamfetol 150 MG, Placebo - Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms | Phase 3 | Recruiting | Axsome Therapeutics, Inc. | 508 | 2026-02-23 | 2026-10-13 |
| A Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Subjects With Binge Eating Disorder Solriamfetol, Placebo - Binge-Eating Disorder | Phase 3 | Enrolling by invitation | Axsome Therapeutics, Inc. | 236 | 2025-02-20 | 2026-08-11 |
| Efficacy and Tolerance of Solriamfetol in Patients Affected with Idiopathic Hypersomnia. Solriamfetol, Placebo - Idiopathic Hypersomnia | Phase 2 | Not yet recruiting | University Hospital, Montpellier | 60 | 2024-09-15 | 2024-09-19 |
| RECOVER-SLEEP: Platform Protocol, Appendix_A (Hypersomnia) Modafinil, Modafinil Placebo, Solriamfetol - Long COVID, Long COVID-19 | Phase 2 | Completed | Duke University | 361 | 2024-08-12 | 2026-06-03 |
| Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN) Solriamfetol 150 mg, Solriamfetol 300 mg, Placebo - Excessive Sleepiness, Shift-work Disorder | Phase 3 | Recruiting | Axsome Therapeutics, Inc. | 520 | 2024-08-01 | 2026-07-24 |
| RECOVER-SLEEP: Platform Protocol Modafinil, Modafinil Placebo, Solriamfetol - Long COVID, Long COVID-19 | Phase 2 | Completed | Duke University | 830 | 2024-07-31 | 2026-01-22 |
| Solriamfetol for the Treatment of Multiple Sclerosis Fatigue Solriamfetol, Placebo - Multiple Sclerosis, Multiple Sclerosis Fatigue | Phase 2 | Recruiting | Johns Hopkins University | 46 | 2024-06-01 | 2026-06-09 |
| Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol Solriamfetol 150 mg, Solriamfetol 300 mg, Placebo - Binge-Eating Disorder | Phase 3 | Recruiting | Axsome Therapeutics, Inc. | 450 | 2024-04-26 | 2026-07-28 |
| Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol Solriamfetol 300 mg, Placebo - Major Depressive Disorder | Phase 3 | Completed | Axsome Therapeutics, Inc. | 346 | 2024-03-18 | 2026-01-05 |
| A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Solriamfetol in the Treatment of Excessive Daytime Sleepiness (EDS) in Patients with Obstructive Sleep Apnea (OSA) Solriamfetol, Placebo - Sleep Apnea, Obstructive, Excessive Daytime Sleepiness | Phase 3 | Completed | Ignis Therapeutics (Suzhou) Limited | 204 | 2023-08-01 | 2025-03-03 |
| Solriamfetol and CBT-I in Patients With Insomnia Disorder Solriamfetol 75 MG, Cognitive Behavioral Therapy for Insomnia (CBT-I), Monitoring - Insomnia | Phase 4 | Completed | University of Pennsylvania | 115 | 2023-07-31 | 2026-05-12 |
| A Study to Assess the Efficacy and Safety of Solriamfetol in Subjects With ADHD (FOCUS) Solriamfetol 150 mg, Solriamfetol 300 mg, Placebo - ADHD | Phase 3 | Completed | Axsome Therapeutics, Inc. | 516 | 2023-07-06 | 2026-02-10 |
| Evaluate Sunosi® PK in Breast Milk and Plasma of Healthy Postpartum Women Following Single Dose Oral Administration Solriamfetol 150 mg Oral Tablet - Narcolepsy, Obstructive Sleep Apnea | Phase 1 | Completed | Axsome Therapeutics, Inc. | 6 | 2021-08-27 | 2023-04-14 |
| WAKIX® (Pitolisant) Pregnancy Registry Pitolisant, Comparator Products - Pregnancy Related, Narcolepsy | Recruiting | Harmony Biosciences Management, Inc. | 1329 | 2021-08-24 | 2026-06-12 | |
| A Controlled Study of Solriamfetol for Attention Deficit Hyperactivity Disorder (ADHD) in Adults Solriamfetol 75 MG, Solriamfetol 150 MG, Placebo - Attention Deficit Hyperactivity Disorder | Phase 2 / Phase 3 | Completed | Massachusetts General Hospital | 66 | 2021-08-06 | 2024-03-04 |
| Clinical Trial of Solriamfetol for Excessive Sleepiness Related to Shift Work Disorder Solriamfetol Oral Tablet, Placebo - Excessive Sleepiness, Shift-work Disorder | Phase 4 | Terminated | Charles A. Czeisler, PhD, MD | 84 | 2021-07-21 | 2025-09-24 |
| Solriamfetol in Binge Eating Disorder Solriamfetol, Placebo - Binge Eating Disorder | Phase 4 | Unknown | Lindner Center of HOPE | 64 | 2021-06-15 | 2023-03-08 |
| Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study Solriamfetol, Placebo - Excessive Daytime Sleepiness, Obstructive Sleep Apnea | Phase 4 | Completed | Axsome Therapeutics, Inc. | 59 | 2021-05-17 | 2026-01-26 |
| A Trial of Solriamfetol in the Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Solriamfetol Oral Tablet [Sunosi], Placebo - Chronic Fatigue Syndrome, Myalgic Encephalomyelitis | Phase 4 | Completed | Rochester Center for Behavioral Medicine | 44 | 2021-04-27 | 2025-04-06 |
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Disorders of Excessive Somnolence (12) · Narcolepsy (8) · Sleep Apnea, Obstructive (8) · Attention Deficit Disorder with Hyperactivity (3) · Binge-Eating Disorder (3) · Depressive Disorder, Major (2) · Fatigue (2) · Post-Acute COVID-19 Syndrome (2) · Sleep Initiation and Maintenance Disorders (2) · Fatigue Syndrome, Chronic (1) · Idiopathic Hypersomnia (1) · Multiple Sclerosis (1) · Parasomnias (1) · Parkinson Disease (1) · Sleep Disorders, Circadian Rhythm (1)
Axsome Therapeutics, Inc. (10) · Jazz Pharmaceuticals (9) · Duke University (2) · Charles A. Czeisler, PhD, MD (1) · Harmony Biosciences Management, Inc. (1) · Ignis Therapeutics (Suzhou) Limited (1) · Johns Hopkins University (1) · Lindner Center of HOPE (1) · Massachusetts General Hospital (1) · Rochester Center for Behavioral Medicine (1) · University Hospital, Montpellier (1) · University of Pennsylvania (1)
United States (26) · Netherlands (6) · Canada (5) · France (5) · Germany (4) · Finland (3) · China (1) · Italy (1) · Spain (1) · Sweden (1) · United Kingdom (1)
Christina Barkauskas, MD (2) · Grace Wang, MD (2) · Jan Ramaekers, PhD (2) · Susan Redline, MD MPH (2) · Bardia Nourbakhsh, MD (1) · Charles A Czeisler, PhD,MD (1) · Craig Surman, MD (1) · David Ward, MD (1) · Joel Young, MD (1) · Millie Gottwald, PharmD (1)
PMID 33226332, PMID 34283019, PMID 36494591, PMID 26298786, PMID 27166238, PMID 30471270, PMID 30521757, PMID 31691827, PMID 31926465, PMID 32353246, PMID 32588401, PMID 33179591, PMID 33394323, PMID 33631141, PMID 34191352, PMID 34606437, PMID 34610482, PMID 36084494, PMID 37819836, PMID 39528111, PMID 40958377, PMID 41128833, PMID 41590992
2015 (1)