Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 14, 2019

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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 National Cancer Institute (NCI) 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.
NCT00052286 Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer Completed Jonsson Comprehensive Cancer Center 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.
NCT00057707 Effects of Modafinil on Brain Function in Patients With Schizophrenia Active, not recruiting National Institute of Mental Health (NIMH) Phase 1 2003-03-01 This study will evaluate whether modafinil improves cognition in patients with schizophrenia and healthy volunteers. Modafinil is a drug that has been FDA approved for day-time sleepiness and allegedly increase the amount of the neurotransmitter dopamine in the frontal cortex of the brain
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Modafinil

Condition Name

Condition Name for Modafinil
Intervention Trials
Fatigue 16
Narcolepsy 12
Cocaine Dependence 11
Healthy 10
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Condition MeSH

Condition MeSH for Modafinil
Intervention Trials
Fatigue 24
Cocaine-Related Disorders 21
Narcolepsy 14
Schizophrenia 11
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Clinical Trial Locations for Modafinil

Trials by Country

Trials by Country for Modafinil
Location Trials
United States 360
Canada 11
France 7
Switzerland 5
Germany 5
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Trials by US State

Trials by US State for Modafinil
Location Trials
California 27
New York 21
Texas 18
Pennsylvania 15
Arkansas 12
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Clinical Trial Progress for Modafinil

Clinical Trial Phase

Clinical Trial Phase for Modafinil
Clinical Trial Phase Trials
Phase 4 24
Phase 3 28
Phase 2/Phase 3 4
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Clinical Trial Status

Clinical Trial Status for Modafinil
Clinical Trial Phase Trials
Completed 83
Unknown status 16
Recruiting 16
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Clinical Trial Sponsors for Modafinil

Sponsor Name

Sponsor Name for Modafinil
Sponsor Trials
National Institute on Drug Abuse (NIDA) 20
Cephalon 19
National Institute of Mental Health (NIMH) 6
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Sponsor Type

Sponsor Type for Modafinil
Sponsor Trials
Other 143
Industry 39
NIH 35
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