49 completed. 49 Phase 2, 5 Phase 1, 4 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 49 | Completed 49 |
| Phase 1 | 5 | Completed 5 |
| Phase 3 | 4 | Completed 4 |
Follow Modafinil: new trials by email Literature Review of Modafinil trials Research Report on Modafinil
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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| Psilocybin Therapy for Chronic Low Back Pain Psilocybin therapy with Zolpidem and Modafinil, Psilocybin therapy with Zolpidem, Psilocybin therapy with Modafinil - Chronic Low-back Pain | Phase 1 / Phase 2 | Completed | Joshua Woolley, MD, PhD | 40 | 2023-12-01 | 2026-11-04 |
| Modafinil Versus Amphetamines for the Treatment of Narcolepsy Type 2 and Idiopathic Hypersomnia Modafinil, Amphetamine-Dextroamphetamine - Idiopathic Hypersomnia, Narcolepsy Without Cataplexy | Phase 2 | Completed | Emory University | 44 | 2019-04-15 | 2024-05-23 |
| Modafinil for the Treatment of Alcohol Use Disorders Modafinil, Placebo - Alcohol Use Disorder | Phase 2 | Completed | The Mind Research Network | 12 | 2017-12-11 | 2020-05-26 |
| Modafinil for Freezing of Gait (FOG) in Parkinson's Disease (PD) modafinil 50mg, Placebo oral capsule - Parkinson Disease | Phase 2 | Completed | University of Arkansas | 21 | 2017-06-13 | 2021-10-27 |
| Developing Adaptive Interventions for Cocaine Cessation and Relapse Prevention Acceptance and Commitment Therapy (ACT), Drug Counseling (DC), Contingency Management (CM) - Cocaine-Related Disorders | Phase 2 | Completed | The University of Texas Health Science Center, Houston | 118 | 2016-11-18 | 2023-02-08 |
| Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients Active comparator: Modafinil + placebo, THN102 300/3, THN102 300/27 - Narcolepsy | Phase 2 | Completed | Theranexus | 51 | 2016-09-01 | 2020-09-04 |
| Improving Therapeutic Learning in Depression: Proof of Concept 250 mg DCS, 100 mg Modafinil, Placebo - Major Depressive Disorder | Phase 2 | Completed | Boston University Charles River Campus | 36 | 2014-09-16 | 2018-09-19 |
| A Phase II Study of Minocycline and Armodafinil for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Esophageal Cancer Armodafinil, Placebo, Minocycline - Esophageal Cancer | Phase 2 | Completed | M.D. Anderson Cancer Center | 22 | 2013-02-01 | 2018-06-06 |
| A Randomized, Placebo-Controlled Trial of Modafinil for Methamphetamine Dependence Modafinil - Methamphetamine Dependence | Phase 2 | Completed | California Pacific Medical Center Research Institute | 72 | 2011-10-01 | 2013-07-02 |
| Modafinil in Treating Children With Memory and Attention Problems Caused by Cancer Treatment for a Brain Tumor modafinil, placebo - Brain and Central Nervous System Tumors, Cognitive/Functional Effects | Phase 2 | Completed | University of South Florida | 112 | 2011-08-01 | 2021-08-13 |
| Single Agent Armodafinil for Patient-Reported Fatigue Following Radiation Therapy for Head and Neck Cancer Armodafinil, Placebo, Questionnaires - Head And Neck Cancer, Fatigue | Phase 1 / Phase 2 | Completed | M.D. Anderson Cancer Center | 26 | 2011-05-19 | 2024-02-14 |
| Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia Armodafinil, Placebo - Nocturia, Daytime Sleepiness | Phase 2 / Phase 3 | Completed | Duke University | 81 | 2011-05-01 | 2017-03-24 |
| Management of Insomnia in Breast Cancer Patients BBT-I, Control, Armodafinil - Insomnia, Fatigue | Phase 2 | Completed | Stanford University | 70 | 2011-01-01 | 2018-11-29 |
| Armodafinil in Treating Fatigue Caused By Radiation Therapy in Patients With Primary Brain Tumors Armodafinil, placebo - Brain Tumors, Nervous System Tumors | Phase 2 | Completed | Wake Forest University Health Sciences | 54 | 2010-08-01 | 2021-09-28 |
| Pharmacodynamic Profile of SPD489 in Healthy Adult Males Undergoing a Nocturnal Period of Acute Sleep Loss SPD489 20 mg, SPD489 50 mg, SPD489 70 mg - Sleep Deprivation | Phase 2 | Completed | Shire | 135 | 2010-04-05 | 2021-06-14 |
| Modafinil, Sleep Architecture and Cocaine Relapse Modafinil, Cognitive Behavioral Therapy - Cocaine Dependence | Phase 2 | Completed | Yale University | 114 | 2010-04-01 | 2016-04-27 |
| Identifying and Treating Arousal Related Deficits in Neglect and Dysphagia Modafinil, Placebo, Baseline - Spatial Neglect, Dysphagia | Phase 2 | Completed | University of Arkansas | 28 | 2010-03-01 | 2016-10-18 |
| Impact of Armodafinil on Neurocognition and Cognitive Fatigue in Multiple Sclerosis (MS) armodafinil - Multiple Sclerosis | Phase 2 / Phase 3 | Completed | University of Missouri, Kansas City | 33 | 2009-09-01 | 2013-10-14 |
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Cocaine-Related Disorders (13) · Fatigue (8) · Disorders of Excessive Somnolence (3) · Schizophrenia (3) · Alcoholism (2) · Glioma (2) · Narcolepsy (2) · Post-Acute COVID-19 Syndrome (2) · Sleep Initiation and Maintenance Disorders (2) · Sleepiness (2) · Stroke (2) · Alcohol-Related Disorders (1) · Astrocytoma (1) · Attention Deficit Disorder with Hyperactivity (1) · Behavior, Addictive (1)
Cephalon (4) · Duke University (4) · The University of Texas Health Science Center, Houston (3) · University of Arkansas (3) · California Pacific Medical Center Research Institute (2) · Kyle Kampman (2) · M.D. Anderson Cancer Center (2) · Medical University of South Carolina (2) · National Institute on Drug Abuse (NIDA) (2) · University of Rochester (2) · Yale University (2) · Abramson Cancer Center at Penn Medicine (1) · Alza Corporation, DE, USA (1) · Boston University Charles River Campus (1) · Burke Rehabilitation Hospital (1)
United States (44) · Belgium (1) · Bulgaria (1) · Canada (1) · France (1) · Hungary (1) · Romania (1)
Christina Barkauskas, MD (2) · Susan Redline, MD MPH (2) · Ahmed Elkashef, M.D. (1) · Andrew Krystal, MD (1) · Charles Dackis (1) · Claire Wilcox, MD (1) · Domenic Ciraulo, M.D. (1) · Dr. Janette McGaugh, MD (1) · Edward G. Shaw, MD (1) · Efrat Aharonovich, PhD (1) · Eudocia Lee, MD (1) · Gantt Galloway, Pharm D. (1) · Gantt Galloway, PharmD (1) · Gary B. Gunn, MD (1)
PMID 41170811, PMID 20092966, PMID 20673554, PMID 20816042, PMID 21035624, PMID 21840138, PMID 22178084, PMID 22217949, PMID 22445683, PMID 22969732, PMID 24315572, PMID 24424425, PMID 25452447, PMID 30621831, PMID 31233323, PMID 33630644, PMID 34559026, PMID 36480395, PMID 39207396, PMID 39306601, PMID 41451557
P50DA009262 (2), 2015 (1), K07CA132916 (1), K23DA016743 (1), P50DA012756 (1), P50DA018185 (1), R01CA026582 (1), R01CA126968 (1), R01DA015366 (1), R01DA016368 (1), R01DA021264 (1), R01DA021690 (1), R01DA023650 (1), R21HD055677 (1), U10CA081851 (1)