36 completed, 8 terminated, 3 recruiting, 2 not yet recruiting. 53 Phase 3, 6 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 53 | Completed 36, Terminated 8, Recruiting 3, Not yet recruiting 2, Unknown 2, Withdrawn 2 |
| Phase 2 | 6 | Completed 4, Recruiting 1, Unknown 1 |
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 |
|---|---|---|---|---|---|---|
| Efficacy and Safety of Modafinil to Treat Fatigue in People With Mitochondrial Disease. Modafinil (M), Placebo - Mitochondrial Disease | Phase 3 | Not yet recruiting | Kenneth Myers, MD | 15 | 2026-12-01 | 2026-10-26 |
| Modafinil for Debilitating Fatigue in Quiescent Inflammatory Bowel Disease MODIFI-IBD Trial) Modafinil, Placebo - Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Chronic Fatigue | Phase 2 / Phase 3 | Recruiting | Radboud University Medical Center | 60 | 2026-08-03 | 2026-09-14 |
| Cognitive Strategies in Early Psychosis 2 Modafinil, D-serine solution, Placebo - Psychosis, Schizophrenia Disorder | Phase 3 | Recruiting | University of Minnesota | 24 | 2026-07-17 | 2026-07-23 |
| Cognitive Strategies in Early Psychosis 1 Modafinil - Cognition, Healthy Participants | Phase 3 | Recruiting | University of Minnesota | 103 | 2025-10-31 | 2026-02-17 |
| Modafinil and Exercise for Post Stroke Fatigue Modafinil 200mg, Placebo, Exercise - Stroke, Fatigue | Phase 3 | Not yet recruiting | University Health Network, Toronto | 212 | 2025-09-01 | 2025-06-10 |
| Treatment for Cognitive Impairment in Depression Modafinil, Placebo - Major Depressive Disorder | Phase 3 | Withdrawn | Stanford University | 2018-12-01 | 2020-03-20 | |
| Modafinil's Effects on Cognition in Remitted MDD Modafinil, Placebo - Major Depressive Disorder, Cognitive Impairment | Phase 3 | Terminated | Unity Health Toronto | 9 | 2018-10-15 | 2019-08-08 |
| Treatment of Fatigue With Methylphenidate, Modafinil and Amantadine in Multiple Sclerosis Amantadine, Modafinil, Methylphenidate - Fatigue in Multiple Sclerosis | Phase 3 | Completed | Johns Hopkins University | 141 | 2017-10-04 | 2020-10-20 |
| Modafinil Versus Placebo for Hypoactive Delirium in the Critically Ill Modafinil, Placebo - Delirium, Respiratory Failure | Phase 3 | Withdrawn | Brigham and Women's Hospital | 2014-01-01 | 2016-11-03 | |
| Armodafinil in Reducing Cancer-Related Fatigue in Patients With High Grade Glioma armodafinil 150 mg, Placebo, armodafinil 250 mg - Fatigue | Phase 3 | Completed | Alliance for Clinical Trials in Oncology | 328 | 2013-06-21 | 2025-01-27 |
| Treatment of Post Stroke Fatigue With a Wakefulness Promoting Agent modafinil, placebo - Stroke, Post Stroke Fatigue | Phase 3 | Terminated | Herlev Hospital | 41 | 2012-10-01 | 2015-06-24 |
| Palliative Morphine With or Without Concurrent Modafinil Modafinil, Placebo - Cancer, Pain Palliation | Phase 3 | Unknown | Dr. Rajendra Prasad Government Medical College | 200 | 2012-09-01 | 2013-01-11 |
| Modafinil in the Treatment of PTSD (Posttraumatic Stress Disorder) Modafinil - Posttraumatic Stress Disorder | Phase 2 / Phase 3 | Unknown | Biomedical Research Foundation | 40 | 2012-08-01 | 2012-11-14 |
| Armodafinil (Nuvigil), Postoperative Recovery of OSA (Obstructive Sleep Apnea) and Obese Patients Nuvigil, Placebo - Obesity, Premature Recovery From Anesthesia | Phase 3 | Completed | University of Texas Southwestern Medical Center | 67 | 2011-08-01 | 2018-12-04 |
| 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 |
| Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder Armodafinil, Placebo - Depression | Phase 3 | Completed | Cephalon | 399 | 2011-03-01 | 2016-05-26 |
| Effects of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy. BF2.649, Vigil, palcebo - Treatment of Excessive Daytime Sleepiness in Narcolepsy | Phase 3 | Completed | Bioprojet | 180 | 2010-11-01 | 2017-01-31 |
| Modafinil in Cancer Related Fatigue Modafinil, Pyridoxine - Cancer Related Fatigue, Quality of Life | Phase 3 | Completed | Indira Gandhi Medical College, Shimla | 217 | 2010-08-01 | 2012-03-23 |
| A Study of the Effectiveness of Armodafinil to Treat Cancer-Related Fatigue in Patients With Multiple Myeloma armodafinil, Placebo - Fatigue, Multiple Myeloma | Phase 3 | Completed | Oncotherapeutics | 50 | 2010-06-01 | 2014-11-06 |
| Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder Armodafinil - Depression | Phase 3 | Terminated | Cephalon | 867 | 2010-04-30 | 2018-09-21 |
Showing 20 of 53. Sign in to see all of them.
Disorders of Excessive Somnolence (15) · Narcolepsy (10) · Fatigue (9) · Sleep Apnea, Obstructive (7) · Cataplexy (5) · Depression (5) · Attention Deficit Disorder with Hyperactivity (3) · Neoplasms (3) · Sleep Apnea Syndromes (3) · Brain Injuries, Traumatic (2) · Chronobiology Disorders (2) · Depressive Disorder, Major (2) · Obesity (2) · Pain (2) · Psychotic Disorders (2)
Cephalon (19) · Bioprojet (3) · Cephalon, Inc. (2) · Duke University (2) · University of Minnesota (2) · Alliance for Clinical Trials in Oncology (1) · Assistance Publique - Hôpitaux de Paris (1) · Biomedical Research Foundation (1) · Brigham and Women's Hospital (1) · Brown University (1) · Dr. Rajendra Prasad Government Medical College (1) · Gary Morrow (1) · Herlev Hospital (1) · Indira Gandhi Medical College, Shimla (1) · Jazz Pharmaceuticals (1)
United States (34) · Canada (7) · France (5) · Germany (4) · Argentina (3) · Australia (3) · Bulgaria (3) · Italy (3) · Poland (3) · South Africa (3) · Spain (3) · Switzerland (3) · Ukraine (3) · Brazil (2) · Croatia (2)
Caroline Demro, Ph.D. (2) · Claudio Bassetti (2) · Sophia Vinogradov, MD (2) · Alyx B. Porter Umphrey, MD (1) · Andrew Krystal, MD (1) · Bardia Nourbakhsh, MD (1) · Enas Kandil, MD (1) · Gary R. Morrow, PhD, MS (1) · Gerald L Weinhouse, MD (1) · Gwendolyn Neibler, DO (1) · James Berenson, MD (1) · Jared M Bruce, PhD (1)
PMID 20564068, PMID 25325609, PMID 16895262, PMID 19270033, PMID 19318599, PMID 19416039, PMID 19880686, PMID 20530317, PMID 21046171, PMID 21206549, PMID 22687392, PMID 24107292, PMID 24337761, PMID 25099397, PMID 25933099, PMID 26011779, PMID 26330288, PMID 26534969, PMID 29113955, PMID 29221779, PMID 32356515, PMID 33242419, PMID 34822113, PMID 34882169, PMID 34935103
2009 (3), 2008 (2), P50MH119569 (2), F32MH075583 (1), P20GM103425 (1), P20RR020146 (1), U10CA037404 (1), U10CA037420 (1), U10CA037447 (1), UG1CA189823 (1)