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Last Updated: November 5, 2024

CLINICAL TRIALS PROFILE FOR MODAFINIL


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505(b)(2) Clinical Trials for MODAFINIL

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT03182413 ↗ Impact of THN102 on Attention, Wakefulness and Cognitive Performance During Total Sleep Deprivation Completed Institut de recherche biomédicale des armées (IRBA), Bretigny sur Orge, France Phase 1 2015-09-01 Study Objectives: THN102 is a new combination between modafinil and flecainide low-dose, a documented glial connexin inhibitor. Efficacy of THN102 was compared to modafinil and to placebo on parameters impaired by total sleep deprivation (SD, lasting 40h). Methods: 20 healthy male subjects participated in a double-blind, randomised, incomplete-block 3-period cross-over trial involving 5 treatments (n=12 per group): placebo (PBO), modafinil 100 mg (MOD), and combinations THN102 (modafinil 100 mg and 1, 3 or 9 mg flecainide as THN1, THN3 and THN9), as 3 oral doses over 18h.
New Combination NCT03182413 ↗ Impact of THN102 on Attention, Wakefulness and Cognitive Performance During Total Sleep Deprivation Completed Theranexus Phase 1 2015-09-01 Study Objectives: THN102 is a new combination between modafinil and flecainide low-dose, a documented glial connexin inhibitor. Efficacy of THN102 was compared to modafinil and to placebo on parameters impaired by total sleep deprivation (SD, lasting 40h). Methods: 20 healthy male subjects participated in a double-blind, randomised, incomplete-block 3-period cross-over trial involving 5 treatments (n=12 per group): placebo (PBO), modafinil 100 mg (MOD), and combinations THN102 (modafinil 100 mg and 1, 3 or 9 mg flecainide as THN1, THN3 and THN9), as 3 oral doses over 18h.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for MODAFINIL

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00033046 ↗ Evaluation of Modafinil as a Cocaine Treatment Medication and Interactions With Cocaine - 1 Unknown status National Institute on Drug Abuse (NIDA) Phase 1 2001-06-01 The purpose of this study is to evaluate modafinil, a cocaine treatment medication, and its interactions with intravenous (IV) cocaine.
NCT00042848 ↗ Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer Completed National Cancer Institute (NCI) Phase 3 2002-08-01 RATIONALE: Modafinil may be effective in relieving fatigue in patients with cancer who are undergoing chemotherapy. The effectiveness of modafinil in relieving chemotherapy-related fatigue is not yet known. PURPOSE: This randomized phase III trial is studying the effectiveness of modafinil in treating fatigue in patients who are receiving chemotherapy for cancer.
NCT00042848 ↗ Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer Completed Gary Morrow Phase 3 2002-08-01 RATIONALE: Modafinil may be effective in relieving fatigue in patients with cancer who are undergoing chemotherapy. The effectiveness of modafinil in relieving chemotherapy-related fatigue is not yet known. PURPOSE: This randomized phase III trial is studying the effectiveness of modafinil in treating fatigue in patients who are receiving chemotherapy for cancer.
NCT00052286 ↗ Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer Completed Cephalon N/A 2002-09-01 RATIONALE: Modafinil may be effective in relieving fatigue and improving behavioral changes such as memory loss in patients who have undergone treatment for primary brain cancer. The effectiveness of modafinil in relieving fatigue and improving behavioral change is not yet known. PURPOSE: This randomized clinical trial is comparing how well two different doses of modafinil work in treating fatigue and behavioral changes in patients who have undergone treatment for primary brain cancer.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for MODAFINIL

Condition Name

Condition Name for MODAFINIL
Intervention Trials
Fatigue 19
Narcolepsy 12
Healthy 12
Cocaine Dependence 12
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Condition MeSH

Condition MeSH for MODAFINIL
Intervention Trials
Fatigue 27
Cocaine-Related Disorders 22
Sleepiness 20
Disorders of Excessive Somnolence 16
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Clinical Trial Locations for MODAFINIL

Trials by Country

Trials by Country for MODAFINIL
Location Trials
United States 368
Canada 15
France 7
Germany 5
Belgium 5
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Trials by US State

Trials by US State for MODAFINIL
Location Trials
California 30
New York 21
Texas 19
Pennsylvania 15
Illinois 12
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Clinical Trial Progress for MODAFINIL

Clinical Trial Phase

Clinical Trial Phase for MODAFINIL
Clinical Trial Phase Trials
Phase 4 27
Phase 3 30
Phase 2/Phase 3 4
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Clinical Trial Status

Clinical Trial Status for MODAFINIL
Clinical Trial Phase Trials
Completed 103
Unknown status 20
Terminated 19
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Clinical Trial Sponsors for MODAFINIL

Sponsor Name

Sponsor Name for MODAFINIL
Sponsor Trials
National Institute on Drug Abuse (NIDA) 21
Cephalon 20
National Cancer Institute (NCI) 6
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Sponsor Type

Sponsor Type for MODAFINIL
Sponsor Trials
Other 174
Industry 48
NIH 38
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